F.D.A. Has 6 Inspectors for 3 Million Shipments of Cosmetics By ERIC LIPTONAUG. 2, 2017
The Food and Drug Administration in Silver Spring, Md., has said it found contamination, illegal ingredients and other problems in the soaring quantities of imported cosmetics. Credit Andrew Harnik/Associated Press
WASHINGTON — The Food and Drug Administration has warned Congress that it is frequently finding contamination, illegal ingredients and other problems in the soaring quantities of imported cosmetics, and that it has only “limited resources” to inspect the shipments.
The warning was part of a letter sent in late June to a House Democrat who is pushing Congress to enact legislation giving the F.D.A. greater powers and resources to regulate cosmetics.
The F.D.A. has the equivalent of just six full-time inspectors to monitor three million shipments of cosmetics coming in each year — lipsticks, eyeliners, nail polish, face powders, tattoo inks and other products — an amount that has doubled in the last decade, said the letter to Representative Frank Pallone Jr., Democrat of New Jersey. He is the top Democrat on the House Energy and Commerce Committee, which oversees the F.D.A.
These products came from 181 countries last year, sent by 29,000 foreign companies, few of which have registered with the F.D.A., as they are not required to do so, the agency told Mr. Pallone.
“Cosmetics imports, by volume, are one of F.D.A.’s larger categories,” Anna K. Abram, an F.D.A. deputy commissioner, wrote in the June 30 letter, adding that the “F.D.A. has limited resources to examine imported cosmetics.”
However, F.D.A. officials and industry executives said they remained confident that most cosmetics sold in the United States — imported or made domestically — were safe.
Document: The F.D.A. Letter on Cosmetics
Of the three million imported cosmetics shipments, the agency physically inspected just 9,871, or about 0.3 percent, last year. It picks those products it has reason to believe might have problems, often based on past checks of material from the same company. The letter said that 15 percent of those inspections resulted in what the F.D.A. calls “adverse findings.”
Laboratory tests were conducted on a smaller sample of those shipments — a total of 364 last year — and 20 percent of those led to adverse findings. The agency found bacterial contamination, illegal color additives that can cause skin or eye injuries, ingredients that were not on the label as required, and unsafe chemical substances like mercury, the agency said.
About 2,000 shipments a year are refused entry to the United States, based on these inspections or other issues; the highest share of those blocked come from China, India, South Korea, Canada and France, the letter said. Imports from China were particularly problematic — as has historically been the case with other products, including children’s toys. Cosmetics imports from China have jumped 79 percent over the last five years, the letter says.
For example, samples examined by the F.D.A. of a Chinese-made product called Kleancolor Frameous Lash & Brow, which sells for just $1, contained hazardous levels of mold, given that its intended area of use was the eye. The F.D.A. also found dangerous levels of mercury — it can cause kidney and nervous system damage — in a product made in Mexico called “Crema Piel De Seda,” or “Silky Skin Cream.” It was marketed to whiten skin, treat acne and remove various skin blemishes.
An F.D.A. official, who spoke on the condition of anonymity, said the real problem was that the agency has no way of knowing how widespread the problem is with imported cosmetics, given that it is doing so few inspections. But she said that the agency inspects only imported cosmetics it has a reason to suspect might have problems, which inflates the rate of adverse findings. The 20 percent adverse-findings figure does not mean that the problem is that widespread in imported cosmetics over all.
“The F.D.A. believes that the vast majority of cosmetic products on the market are safe, but our information on the universe of cosmetics is limited,” said Linda Katz, director of the office of cosmetics and colors, in a written statement.
Mr. Pallone, in an interview, said that the data the F.D.A. provided could help convince Congress to take up legislation to strengthen regulation of imported cosmetics. The idea has been embraced by some congressional Republicans as well as many major companies in the industry, who could benefit if cheap imports (including sometime counterfeits of their brand-name products) are subject to more scrutiny.
“The time is ripe to deal with the cosmetic issues, given the problems with imports,” Mr. Pallone said. He intends to reintroduce his proposal to expand the regulation of cosmetics, including imports, as part of a larger bill that would fund greater oversight of over-the-counter drugs.
Lisa Powers, a spokeswoman for the Personal Care Products Council, which represents the nation’s largest cosmetics makers, declined to comment on F.D.A. statistics regarding problems found with imported products, saying she had not seen the agency letter.
Craig Weiss, an executive at the Consumer Product Testing Company, which does thousands of tests a year on cosmetics products on behalf of companies in the industry, said he questioned how serious the health threat was, as most of the issues the F.D.A. finds were minor — for instance, labeling flaws or the use of color additives that happen not to be approved in the United States.
But he agreed that federal regulations might help the industry. “I have no issue with the F.D.A. upping the game,” he said. “It would stop the craziness and the attacks from the consumer activists.”
For now, President Trump’s 2018 budget proposal for the F.D.A. would slash spending for cosmetics imports testing from the roughly 10,000 conducted last year to about 1,600, which has angered consumer advocates.
“We are flying blind,” said Scott Faber, a lobbyist at the Environmental Working Group. “And until we have the rules and resources that enforce them, we will continue to be flying blind.”
The Honorable Frank Pallone, Jr.
Ranking Member JUNE 30 2017
Committee on Energy and Commerce
House of Representatives
Washington, DC. 20515—6] 15
Dear Representative Pallone:
Thank you for your letter of December 20, 2016, regarding the safety of imported cosmetics. The Food and Drug Administration (FDA or the Agency) shares your interest in helping to ensure the safety of cosmetic products used by American consumers.
In your letter, you asked about imports of personal care products. The Federal Food, Drug and Cosmetic (FD&C) Act does not include a definition of “personal care products.” People often use the term "personal care products" to refer to a Wide variety of items that can include cosmetics, certain devices, and nonprescription drugs, which are regulated by FDA, and some products regulated by the Consumer Product Safety Commission that are intended for personal care. 'By agreement with your staff, this response provides data on imported cosmetics.
By way of background, all imported products regulated by FDA are required to meet the same FDA requirements as domestic products. Articles offered for import must comply with applicable laws and regulations at the time of entry to the United States. If a product is, or appears to be, among other things, adulterated or misbranded at the time of entry to the United States, it is subject to refusal of admission.
Cosmetic imports, by volume, are one of FDA’s larger categories of imports, consisting of more than 2.9 million entry lines1 in Fiscal Year (FY) 2016, yet the Agency’s cosmetics program is one of its smallest. Not only is the volume of cosmetic imports quite significant, but many different countries and manufacturers export cosmetics to the United States. FDA has limited resources to examine imported cosmetics.
in response to your request, we have compiled data related to recent years of cosmetic imports, including information on the volume of such imports, FDA’S efforts to screen those products, and problems identified as a result of our screening. We have restated your specific requests for information below in bold type below, followed by our responses.
1. The number and kinds of personal care products imported each year.
E An import entry can consist of one or multiple products. When multiple products are included under the same entry number. each product will be identified as a separate “line" or “entry line" under that entry,
US. Food a Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Page 2 - The Honorable Frank Pallone, Jr.
in FY 2016, 2.9 million lines of cosmetics entered the United States through the FDA import process. Taken together, these imports represent virtually every type of cosmetic marketed in this country, including lipsticks, eyeliners. nail polish, face powders, tattoo inks and more. in FY 2016, 181 different countries were declared as the origin of cosmetics imported into the United States.
The lines of cosmetic imports entering this country have doubled over the last ten years, and there has been a steady and substantial increase in cosmetic imports each of the past five years. There were over 800,000 more import lines in FY 2016 than in FY 2011. Some countries have notably increased their exports to the United States over the past five years, including China by 79 percent. Mexico by 61 percent, and Canada by 60 percent. Canada and France are the two largest exporters of cosmetics to the United States, and a significant volume is produced in other countries such as China. India, Mexico, Korea and Taiwan.
Approximately 29,000 foreign companies have been identified as the manufacturers or exporters of imported cosmetics in our import records, although few have voluntarily registered with FDA. FDA does not have authority to require registration for domestic or foreign cosmetic manufacturers, as it does for other commodities; as a result, the actual number of manufacturers may be different.
2. The number of imported products subject to inspections each year.
In FY 2016, of the 2.9 million lines of cosmetic products that arrived at US. ports. 9,871 received a physical examination by FDA inspectors, a rate well under one percent. We note that FDA conducts an electronic review of all imports via a risk—based screening tool and focuses inspection and sampling resources on those products with the potential for the greatest impact on public health.
3. The number of contaminated products intercepted each year.
FDA can refuse to allow entry of a product into this country if either electronic or physical examination suggests a potential violation of FDA requirements. Approximately 2,000 such cosmetic lines are refused each year, for reasons including labeling violations, the use of illegal color additives, and the appearance of contamination with filth or other contaminants. Countries with the ten highest refusal rates are China, India, Korea, Canada, France, Taiwan, Germany, the United Kingdom. Mexico, and Japan.
Of the 9.871 cosmetic imports physically examined by FDA in 2016, inspectors reported adverse findings with 1,474 of those imports. a rate of 15 percent. A number of those cosmetic imports were sampled and tested within FDA laboratories in 2016. Of the 364 subjected to laboratory testing, 73 resulted in adverse findings, a rate of 20 percent. The principal reasons for adverse
Page 3 — The Honorable Frank Pallone, Jr.
findings in laboratory tests were the presence of illegal color additives and microbial contamination. By a large margin, imports from China were identified with these concerns.
FDA currently has a number of Import Alerts involving specific cosmetic products or importers. import alerts inform FDA field staff and the public that the Agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of FDA laws and regulations. The principal reasons for issuing import alerts covering cosmetics have been illegal color additives, unsafe chemical substances, and microbial contamination.
The following current Import Alerts provide examples of the range of problems found with some cosmetic imports:
Skin Whitening Creams (which FDA also classifies as drugs), labeled as cosmetics, that contain high levels of mercury;
Eyeliners containing a product known as “Kohl,” because of its heavy metal content;
Anti-aging creams with structure-function and/or disease claims which make these products drugs. These products lack FDA approval as a drug and are unapproved new
drugs;
Cosmetic kits found with high levels of Citrobacter, Pseudomonas, and Staphylococcus bacteria;
Eye makeup containing color additives, such as D&C Red #10 and D&C Red #7. that have been banned for decades as hazardous for eye exposure:
Hairsprays that contain methylene chloride, an aerosol product that is a banned cosmetic ingredient under 21 CFR 700.19; and
Temporary tattoo products that contain unapproved color additives and often falsely claim to be "FDA Approved."
Thank you for contacting us concerning this matter. If you have any further questions or concerns, please let us know.
Sincerely,
xxxxxxxxxxxxx
Anna K. Abram Deputy Commissioner for Policy, Planning. Legislation and Analysis
FDA COSMETICS WARING LETTERS
FDA Announces Final Rule on Bovine Spongiform Encephalopathy
March 17, 2016
The U.S. Food and Drug Administration today issued a rule finalizing three previously-issued interim final rules designed to further reduce the potential risk of bovine spongiform encephalopathy (BSE), sometimes referred to as “mad cow disease,” in human food.
The final rule provides definitions for prohibited cattle materials and prohibits their use in human food, dietary supplements, and cosmetics, to address the potential risk of BSE. These materials include:
- Specified risk materials (SRMs ): brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia (DRG) of cattle 30 months of age and older, and the tonsils and distal ileum of the small intestine from all cattle.
- The small intestine from all cattle unless the distal ileum has been properly removed,
- Material from nonambulatory disabled cattle,
- Material from cattle not inspected and passed, or mechanically separated (MS) (Beef).
The rule additionally confirms that milk and milk products, hides and hide-derived products, tallow that contains no more than 0.15 percent insoluble impurities, and tallow derivatives are not prohibited cattle materials. The FDA also finalized the process for designating a country as not subject to BSE-related restrictions applicable to FDA regulated human food and cosmetics.
Finally, the rule provides a definition of gelatin and clarifies that gelatin is not considered a prohibited cattle material if it is manufactured using the customary industry processes specified. Gelatin was never considered a prohibited cattle material, but FDA had never specifically defined gelatin in past IFRs.
The FDA is taking this action to minimize human exposure to certain cattle material that could potentially contain the BSE agent. It is important to note that the U.S. has long had measures in place to prevent the introduction and spread of BSE, including those affirmed in this rule; therefore the risk of human exposure to the BSE agent from FDA-regulated human food and cosmetics is negligible.
For more information:
- Federal Register Notice: Use of Materials Derived From Cattle in Human Food and Cosmetics (Final rule; adoption of interim final rule as final with amendments)
- Questions and Answers on BSE
- Bovine Spongiform Encephalopathy Information
TUESDAY, JULY 18, 2017
USDA announces Alabama case of Bovine Spongiform Encephalopathy Alabama
SUNDAY, JULY 30, 2017
PRION2017 Low levels of classical BSE infectivity in rendered fat tissue
THURSDAY, JULY 20, 2017
USDA OIE Alabama Atypical L-type BASE Bovine Spongiform Encephalopathy BSE animal feeds for ruminants rule, 21 CFR 589.200
SATURDAY, JULY 29, 2017
Risk Advisory Opinion: Potential Human Health Risks from Chronic Wasting Disease CFIA, PHAC, HC (HPFB and FNIHB), INAC, Parks Canada, ECCC and AAFC
PRION 2017 DECIPHERING NEURODEGENERATIVE DISORDERS
Subject: PRION 2017 CONFERENCE DECIPHERING NEURODEGENERATIVE DISORDERS VIDEO
PRION 2017 CONFERENCE DECIPHERING NEURODEGENERATIVE DISORDERS
PRION 2017 CONFERENCE VIDEO
Chronic Wasting Disease CWD TSE Prion to Humans, who makes that final call, when, or, has it already happened?
TUESDAY, JUNE 13, 2017
PRION 2017 CONFERENCE ABSTRACT First evidence of intracranial and peroral transmission of Chronic Wasting Disease (CWD) into Cynomolgus macaques: a work in progress
TUESDAY, JULY 04, 2017
*** PRION 2017 CONFERENCE ABSTRACTS ON CHRONIC WASTING DISEASE CWD TSE PRION ***
TUESDAY, JUNE 13, 2017
PRION 2017 CONFERENCE ABSTRACT Chronic Wasting Disease in European moose is associated with PrPSc features different from North American CWD
URINE
SUNDAY, JULY 16, 2017
*** Temporal patterns of chronic wasting disease prion excretion in three cervid species ***
WEDNESDAY, JULY 26, 2017
Chronic wasting disease continues to spread Disease of cervids causing local population declines
SUNDAY, JULY 30, 2017
Do we need to explain the occurrence of atypical scrapie?
TUESDAY, JULY 18, 2017
MINK FARMING USA TRANSMISSIBLE MINK ENCEPHALOPATHY TSE PRION DISEASE SURVEILLANCE AND TESTING
WEDNESDAY, APRIL 05, 2017
Disease-associated prion protein detected in lymphoid tissues from pigs challenged with the agent of chronic wasting disease
TUESDAY, APRIL 18, 2017
*** EXTREME USA FDA PART 589 TSE PRION FEED LOOP HOLE STILL EXIST, AND PRICE OF POKER GOES UP ***
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APHIS USDA Emerging Animal Disease Preparedness and Response Plan July 2017
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BSE INQUIRY DFA 17 Medicines and medical devices
Friday, January 10, 2014
vpspr, sgss, sffi, TSE, an iatrogenic by-product of gss, ffi, familial type prion disease, what it ???
THURSDAY, JULY 13, 2017
TEXAS CREUTZFELDT JAKOB DISEASE CJD TSE PRION
National Prion Center could lose all funding just as concern about CWD jumping to humans rises
SATURDAY, JULY 15, 2017
*** National Prion Center could lose all funding just as concern about CWD jumping to humans rises
SATURDAY, JULY 22, 2017
Why the U.S. Needs to Continue Prion Disease Surveillance, instead of reducing funding to zero
BSE INQUIRY DFA 18 COSMETICS
COVER SHEET FOR DFA 18
24 JANUARY 2000
The published update sets out revisions for this DFA as at 18 November 1999.� Further relevant evidence and corrections are noted below.
Further relevant evidence
Further relevant evidence may be found in:
S Pickles 115I
S Lowson 104E
T 127 (transcript of Mr Lowson�s evidence on 25 November 1999)
Corrections
Please note the following corrections:
para 111A� The document is YB91/3.7/3.1-3.2
para 110A ��� [Insert new para 110A:]
On 12 July 1990 Mr Lowson sent a minute to Dr MacOwan about further transmission studies in mice. [Insert new footnote 113A: YB90/7.12/28.1]� In response to Dr MacOwan�s minute of 9 July 1990, he said that Dr Tyrrell had �identified the need for research into possible unpredicted routes of transmission.�� He noted that Animal Health Division had begun with an enquiry at slaughterhouses to establish what happens to the whole range of bovine tissues.� He then said that �[p]ending the results of this enquiry I would not see a need to direct resources to this item.�
DFA 18 ������ ����
�Cosmetics
Draft Factual Accounts ������������������������������������������� 29 October 1999
This is one of a series of documents intended to provide an account as at the date of publication of the factual evidence received by the Inquiry. The documents do not make any judgements about the implications of the facts or point to any conclusions. They are simply working drafts seeking in a neutral way to set out relevant evidence. They do not contain any expressions of opinions by the Secretariat or the Committee of the Inquiry. The series will only cover certain areas of the evidence.
The DFAs may contain inaccuracies and omissions. The purpose of publishing them is to invite corrections, additions and comments. The Inquiry has received suggestions for such corrections and additions in relation to DFAs already published. This is helpful in furthering the work of the Inquiry; all suggestions are considered and used to update the Secretariat�s working papers which will form the basis of the Committee�s Report in due course. The DFAs should not be treated as setting out a complete and accurate appreciation of the relevant facts.
You are invited to let the Secretariat know of any errors, inaccuracies or material omissions in this DFA. It would be helpful if you could distinguish suggested amendments to the DFA from more general comments which would not involve such amendment. Please write to:
������������������ The Secretary
The BSE Inquiry
6th Floor
Hercules House
Hercules Road
London SE1 7DU
The BSE Inquiry
6th Floor
Hercules House
Hercules Road
London SE1 7DU
Email to : inquiry@bse.org.uk
Responses should reach the Secretariat by 15 November 1999 for them to be of most assistance to the Inquiry.
Cosmetics
What is a cosmetic product?............................................................................................... 4
Regulatory framework......................................................................................................... 4
European Community Legislation.......................................................................................... 4
The Cosmetics Directive......................................................................................................... 4
Action by Member States........................................................................................................ 6
UK statutory framework.......................................................................................................... 6
The general safety requirement............................................................................................... 6
Safety regulations made by the Secretary of State................................................................ 7
The Cosmetic Products (Safety) Regulations....................................................................... 8
Monitoring and Enforcement.................................................................................................. 9
Enforcement authorities.......................................................................................................... 9
Prosecution for breach of s 10 and s 12.............................................................................. 10
Enforcement authorities� powers......................................................................................... 10
Prohibition Notices and Notices to Warn - Secretary of State�s powers......................... 11
Structure of DH and DTI areas responsible for cosmetics................................................ 12
Administrative and professional staff: their roles and responsibilities............................ 12
Communication between the relevant sections of DH and DTI......................................... 14
Risks associated with tallow and gelatine............................................................................ 15
Chronology of events.......................................................................................................... 16
1987-88.................................................................................................................................. 16
1989........................................................................................................................................ 16
1990........................................................................................................................................ 18
SEAC first meeting: other routes of transmission............................................................. 24
1991........................................................................................................................................ 30
SEAC considers cosmetics................................................................................................... 31
DH contacts CTPA................................................................................................................. 35
The Bovine Offal (Prohibition) (Amendment) Regulations............................................... 41
1992........................................................................................................................................ 43
Meeting with CTPA............................................................................................................... 48
1993........................................................................................................................................ 54
1994........................................................................................................................................ 60
German proposals.................................................................................................................. 60
1995........................................................................................................................................ 63
1996........................................................................................................................................ 64
1. EU Directive 76/768/EEC defined a cosmetic product as:[1]
�Any substance or preparation intended for placing in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or principally to cleaning them, perfuming them or protecting them in order to keep them in good condition, change their appearance or correct body odours.�
2. The Cosmetic Products (Safety) Regulations of 1984 and 1989 defined cosmetic products similarly to the Directive, but expressly excluded items used wholly for the purpose of treating or preventing disease.� Directive 76/768/EEC was amended by Directive 93/35/EC.
3. The Cosmetic Products (Safety) Regulations 1996 now define a cosmetic product as:[2]
�Any substance or preparation intended to be placed in contact with any part of the external surfaces of the human body (that is to say, the epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours except where such cleaning, perfuming, protecting, changing, keeping or correcting is wholly for the purpose of treating or preventing disease.�
4. Examples of cosmetic products include: creams, emulsions, and lotions for the skin; make-up powders; toilet soaps; perfumes; deodorants; hair care products; and anti-ageing products.
5. Some cosmetic products contain animal materials, including bovine materials.� For example, bovine tallow and glycerine were used in soap. Glycerine was also used in skin creams and lotions.� Other tallow derivatives were used in products such as shaving sticks and stick deodorants.[3]� Other products, such as anti-ageing creams and other exotic products, may contain other bovine extracts.� Prior to the emergence of BSE this might have included extracts derived from specified bovine offal.
6. The laws of Member States relating to cosmetic products are governed by Directive 76/768/EEC of 27 July 1976 (�the Cosmetics Directive�).
7. The Cosmetics Directive seeks to ensure the safety of cosmetics and their unhindered trade throughout the EU.� In relation to safety, article 2 formerly provided:
�Cosmetic products put on the market in the Community must not be liable to cause damage to human health when they are applied under normal conditions of use.�
8. Article 2 was amended on 14 June 1993 by Directive 93/35/EC and now reads:
�A cosmetic product put on the market within the Community must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use, taking account, in particular, of the product�s presentation, its labelling, any instructions for its use and disposal as well as any other indication or information provided by the manufacturer or his authorised agent or by any other person responsible for placing the product on the Community market.�
9. The Cosmetics Directive does not require any prior approval or licence from regulatory agencies before cosmetic products can be marketed, unlike those governing medicines or pesticide products.� It places the onus on manufacturers and suppliers to ensure that the product is safe for the use intended.[4]
10. Member States have a duty to �take all necessary measures to ensure no unsafe cosmetics are placed on the market.�[5]� The annexes of the Cosmetics Directive list substances that must not be used in cosmetics and substances whose use is regulated.� They also contain lists of substances (�the prescribed lists�) permitted for certain uses (preservatives, colorants, sunscreens) and it is only these substances (up to a given concentration limit) that are permitted to be used for those purposes in cosmetic products.[6]�
11. Member States must also ensure that cosmetics are only marketed if their packaging, containers, or labels bear certain particulars.
12. Proposals to amend the prescribed lists are considered by the European Commission�s Cosmetic Products Working Party, which consists of representatives from Member States and the industry.�� Decisions on proposals to amend the annex lists are made by the Committee on the Adaptation to Technical Progress, which is established under Article 9 and comprises representatives of Member States chaired by the Commission.� Essentially, the Committee votes on proposed amendments to the Directive after they have been considered by the Working Party.[7]�
13. Both the Working Party and the Committee have access to the Scientific Committee on Cosmetology (SCC).� The SCC is an independent multi-disciplinary committee of scientists appointed by the Commission to assess the safety of cosmetic ingredients.� Member States benefit from the expertise of the SCC in addition to advice from their own national scientific advisers. Advice to the UK is provided by toxicologists within the Department of Health and chemists in the Laboratory of the Government Chemist.[8]�
14. The Cosmetics Directive limits the action Member States can take to regulate cosmetics.� If a product is listed in and complies with the conditions set out in Annex IV of the Directive, or is a permitted product, the UK Government cannot prohibit its use, except in accordance with Article 12.� This provides that if a Member State notes on the basis of �a substantiated justification� that a cosmetic product represents a hazard to health (although complying with the Directive), it may provisionally prohibit its marketing or subject it to special conditions.� The State must immediately inform the other Member States and the Commission stating the grounds for its decision.� The Commission must consult the Member States concerned and then deliver an opinion without delay, backed by appropriate action.�
15. Regarding labelling of cosmetic products, a Member State can act unilaterally only to the extent permitted by the Cosmetics Directive.� The permissible areas relate to such matters as whether the product must be marked with the country of origin (for goods manufactured outside the Community) (article 6(1)(a)) or whether information is given in a particular language (article 7(2)).
16. The primary UK legislation governing product safety is the Consumer Protection Act 1987 (�the Act�), [9] and, since 1994, the General Product Safety Regulations 1994.
17. Section 10 of the Act makes it an offence to supply consumer goods that fail to comply with the general safety requirement.� For this purpose, consumer goods fail to comply with the general safety requirement if they are not reasonably safe having regard to all the circumstances, including:
�(a) the manner in which, and purposes for which, the goods are being or would be marketed, the get-up of the goods, the use of any mark in relation to the goods and any instructions or warnings which are given or would be given with respect to the keeping, use or consumption of the goods;
(b)�� any standards of safety published by any person either for goods of a description which applies to the goods in question or for matters relating to goods of that description; and
(c)�� the existence of any means by which it would have been reasonable (taking into account the cost, likelihood and extent of any improvement) for the goods to have been made safer.�[10]
18. �Safe� means such that there is no risk (or no risk apart from one reduced to a minimum) that the goods will (whether immediately or after a definite or indefinite period) cause death or personal injury to any person.[11]� Goods are not regarded as failing to comply with the general safety requirement in respect of anything shown to be attributable to compliance with any requirement imposed by or under any enactment or with any Community obligation.� Similarly, goods are not regarded as failing to comply with the general safety requirement in respect of any failure to do more in relation to any matter than is required by any safety regulations, standards of safety approved by or under any such regulations, or designated enactment or subordinate legislation.[12]�
19. �Consumer goods� means any goods which are ordinarily intended for private use or consumption, subject to a number of exceptions, which are not material for present purposes.[13]�
20. By virtue of s 11, the Secretary of State may by regulation �make such provision as he considers appropriate� for the purpose of securing:
�(a) that goods to which [the section]applies are safe;
(b) that goods to which [the section] applies which are unsafe, or would be unsafe in the hands of persons of a particular description, are not made available to persons generally or, as the case may be, to persons of that description; and
(c) ����������� that appropriate information is, and that inappropriate information is not, provided in relation to goods to which [the section] applies�[14]
21. The Secretary of State has a wide discretion as to the nature of regulations made under the Act.� However, section 11(2)[15] specifically contemplates, among other things, the following:
(i.) ��Prohibiting the supply of goods or raw materials.
(ii.) ��Requiring goods to conform to standards or descriptions.
(iii.) ��Regulations as to the testing or inspection of goods.
(iv.) ��Requiring information to be supplied to specific people.
22. Regulations made, in part, under s 11 of the Act give effect to the Cosmetics Directive in UK law. The Cosmetic Products (Safety) Regulations 1984 (made under a predecessor of the Act), which came into force in stages between 1984 and 1988, were replaced as of 1 January 1990 by the Cosmetic Products (Safety) Regulations 1989 (�the 1989 Regulations�).
23. The main provisions of the 1989 Regulations are as follows:
(i.) A cosmetic product shall not be liable to cause damage to human health when it is applied under normal conditions of use (reg 3(1)).
(ii.) No cosmetic product may contain any substance listed in column 2 of Schedule 1, unless it is only a trace that could not reasonably have been removed during or after manufacture (reg 4(2)).
(iii.) A cosmetic product must not contain any substance listed in column 2 of Schedule 2 unless specified requirements in that schedule are satisfied (reg 4(3)).
(iv.) The Secretary of State may authorise the use in a cosmetic product of any substance not listed in either schedule (reg 5(1)).� In giving authorisation the Secretary of State may impose conditions relating to the use of the substance (reg 5(2)).
(v.) There are various conditions and standards for labelling and packaging (reg 6).
24. The effect of the specific Community and UK legislation on cosmetics (i.e. principally the Cosmetics Directive and the 1989 Regulations) is that there was, at the time when BSE and cosmetics was first under consideration, fairly limited scope for the application of s 10 of the Act.
25. Section 10 has now been for most purposes disapplied by the General Product Safety Regulations 1994 (regulation 5), which implement the General Product Safety Directive (Council Directive 92/59/EEC on General Product Safety).� Where a product is the subject of provisions of Community law other than the General Product Safety Directive (such as the Cosmetics Directive), the Regulations apply only in so far as those other provisions do not make specific provision governing an aspect of the safety of the product (regulation 4). The General Product Safety Regulations came into force on 3 October 1994. This means that there is virtually no scope for the application of the General Product Safety Regulations to the supply of cosmetics.
26. The Department of Trade and Industry (DTI) has policy responsibility for the safety of cosmetics in the UK.� DTI is not aware of any enforcement action that has been taken regarding BSE in cosmetics.[16]� No regulations were made relating specifically to BSE in cosmetics during the period covered by the BSE Inquiry�s terms of reference.
27. Under section 27(1)(a) of the Act, every trading standards authority in Great Britain has a duty to enforce within their area the safety provisions and any regulations made under the Act.[17] The everyday responsibility for enforcing the 1989 Regulations therefore falls to the trading standards departments of local authorities.[18] Under s 27(1)(b) of the Act the Secretary of State may by regulation transfer these duties to other bodies who agree to the transfer.[19]
28. The Act confers a number of enforcement powers on �enforcement authorities.�� Pursuant to s 45 of the Act, �enforcement authority� means:
(i.) The Secretary of State.
(ii.) Any other Minister of the Crown in charge of a Government department.
(iii.) Any such department.
(iv.) Any authority, council or other person on whom functions under the Act are conferred by section 27.
29. It is an offence by virtue of s 10 of the Act to supply, or offer or agree to supply, any consumer goods that fail to comply with the general safety requirement. Failure to comply with certain prohibitions or requirements of safety regulations is also an offence, under s 12 of the Act.� The bringing of prosecutions in relation to these offences is one of the duties of trading standards authorities.� There are no established rules as to when a prosecution will be brought.� Factors generally taken into account are: the magnitude of danger posed to consumers; whether the defect is isolated or indicative of a more general failure; the offender�s attitude and whether steps have been taken to rectify the problem; and past record in terms of safety compliance.[20]
30. In addition to their prosecution powers, enforcement authorities are given a number of further powers, including the following:
(i.) Power to serve a suspension notice prohibiting the person on whom it is served from supplying goods for up to six months without the consent of the enforcement authority, where the enforcement authority has reasonable grounds to suspect that a safety provision has been contravened in relation to the goods.� The notice may require the person on whom it is served to keep the authority informed as to the whereabouts of the goods.[21]� The DTI have stated that the imposition of a suspension notice is commercially disrupting and may effectively terminate the supply of a product.� However, the notice only binds those on whom it is served, and given that is impractical to serve notices on all retail outlets, a suspension notice has little practical effect if products are already widely circulated.[22]
(ii.) Power to apply to the magistrates� court for a forfeiture order applying to goods on the ground that there has been a contravention in relation to the goods of a safety provision.� Where goods are forfeited this means they are to be destroyed in accordance with the court�s directions, unless the court directs that they shall be released to a specified person.[23]� The DTI have stated that, as with a suspension notice, a forfeiture order applies only to the recipient, and so will not have the effect of a comprehensive ban.[24]
(iii.) Power to purchase goods for the purpose of ascertaining whether any safety provision has been contravened.[25]
(iv.) Power for an authorised officer of the enforcement authority to enter any premises, inspect any goods, or examine any procedure for the purpose of ascertaining whether any safety provision has been contravened.� The officer also has power in appropriate circumstances to require the production of records and to seize and detain goods.[26]
31. Section 13 of the Act gives the Secretary of State power to:
(i.) Serve on any person a prohibition notice prohibiting that person from supplying any goods which the Secretary considers unsafe and which are described in the notice (s 13(1)(a)).
(ii.) Serve on any person a notice to warn requiring that person to publish at his own expense a warning about any relevant goods which the Secretary of State considers are unsafe and which he supplies or has supplied and which are described in the notice (s 13(1)(b)).[27]
32. Contravention of a prohibition notice or a notice to warn is an offence by virtue of s 13(4) of the Act.�
33. The Secretary of State may also, by virtue of s 18 of the Act, serve on a person a notice requiring him to provide information or records where the Secretary of State considers that he requires the information for the purpose of deciding whether to make, vary or revoke any safety regulations; to serve, vary or revoke a prohibition notice; or to serve or revoke a notice to warn.[28]�
34. In his statement to the BSE Inquiry, Mr Richard Roscoe, Head of the Chemical Hazards Section of the Consumer Safety Unit of the DTI,[29] says �Whilst I was in the Consumer Safety Unit, the DTI never used Prohibition Notices under section 13 of the Consumer Protection Act to prohibit the use of cosmetic ingredients not covered by this Regulation, because there was never a need.�[30]�
35. The DTI has also found that, in practice, public statements (e.g. press notices) are a quicker and more effective way of protecting the public than notices to warn, and the notice to warn procedure has never been used.[31] No power exists to recall products.
36. Within DTI overall responsibility for the safety of cosmetics falls to the Consumer Safety Unit (CSU).� Within the CSU, the Chemical Safety Section has day to day responsibility for cosmetics.
37. Mr D Jones was the Grade 5 Head of CSU with overall responsibility for cosmetics until 1995.� Mr P Mason succeeded him.� Mr Robin Hope preceded Mr Jones.[32]
38. Mr R J Roscoe was Grade 7 Head of the Chemical Hazards Section of the CSU from 1983 to 1992, with specific responsibility for ensuring the safety of cosmetics sold in the UK.[33]� His direct line managers were Mr Hope and then Mr Jones.� Mr Roscoe copied all letters and minutes to them and they met regularly.� They had regular branch meetings every week and if there was a serious problem Mr Roscoe would consult them.[34]� However, Mr Roscoe cannot recall referring any specific problem relating to cosmetics to his Grade 5; in his opinion there were no problems or issues that arose when he was dealing with cosmetics that he could not handle himself.[35]� Mr Roscoe�s Grade 5 never interfered with his proposed course of action in relation to BSE; Mr Roscoe states that there was no need for them to do so.[36]� Mr John Walker replaced Mr Roscoe in 1992.� Mr Walker was in turn replaced by Dr William Trott in 1995.[37]
39. Mrs Maria Payne was a Higher Executive Officer (now Range 8) and assisted the Grade 7 Heads of the chemical safety section from March 1990.� She reported mainly to Mr Roscoe (and subsequently his successors), but also reported directly to Mr Jones in some matters.[38]� In her statement to the BSE Inquiry Mrs Payne says that she was responsible for developing policy on regulation covering the safety of chemicals, including ingredients used in cosmetic products.� This entailed formulating and negotiating chemical safety Directives and making and administering UK implementing Regulations to control hazardous chemicals.� Until April 1997 she was also responsible for heading-up the UK delegation to the European Commission�s Working Party of cosmetic experts (the Cosmetic Products Working Party) and also the Committee on the Adaptation to Technical Progress.[39]
40. A number of staff within DH were also involved with cosmetics issues.
41. Dr Pickles (Principal Medical Officer, Grade 4) worked in the Med SEB/B Division (later renamed Med ISD3 and then ISP/3) and held the lead responsibility in DH for assisting the Chief Medical Officer (then Sir Donald Acheson) in matters related to BSE from 1988 to 1990.� She continued to hold the professional lead until 1991.[40]
42. Dr Wight joined the Department of Health in June 1991 and took over professional responsibility for BSE from Dr Pickles in September 1991.� From late 1991 to 1 April 1995 Dr Wight was a Senior Medical Officer and Section Head in the Health Aspects of the Environment and Food Medical Division (HEF (M)).� When HEF (M) was integrated with its administrative counterpart on 1 April 1995, Dr Wight became head of a unit within the new Division.� In her statement to the BSE Inquiry Dr Wight says she took the DH lead on drawing BSE to the attention of the cosmetics industry.[41]
43. Dr R J Fielder joined the DH as a Principal Scientific Officer in 1984, and was originally part of the Medical Toxicology Environmental Protection (MED TEP) Division.� From 1988 to 1992 he was Section Head in MED TEH/HEF (M) 2.� From 1992 to 1995 he was also Section Head in HEF (M) 3.� From 1995 onwards he was Unit Head, Chemical Toxicology Unit, HEF2.� He had a number of responsibilities relating to the toxicology of chemicals used in food, consumer products and the environment.� In particular, from 1985 he provided advice to CSU on the toxicology of chemicals used in consumer products including cosmetics.� From 1988 he was a member of the EC Scientific Committee on Cosmetology.� He was the senior toxicological adviser within DH.[42]�
44. Dr R Singh worked as a Senior Medical Officer in Toxicology and Environmental Health Division (MED (TEH/TEP)/HEF (M)) from November 1987 to May 1992.� During that time, in relation to cosmetics, Dr Singh was the medical, and Dr Fielder the scientific liaison with the DTI.[43]�
45. Throughout the relevant period, Dr Fielder had support from Higher Scientific Officers, who spent a proportion of their time in the consumer product area.� They were also members of the UK delegation to the EC Cosmetic Products Working Party and also the Committee on the Adaptation to Technical Progress.� They were Dr I Dewhurst (1988-1990), Dr D Gott (1991-1993), and Ms C Mulholland (1993-1997).[44]�
46. Mr Murray was a Head of Section in HEF (A) from June 1990 until 1995. Between 1990 and 1993 he was also DH Secretariat to SEAC.� Soon after he joined HEF, Mr Murray discussed with Dr Pickles the suggestion that he should take over the administrative responsibility for BSE from Dr Pickles, and subsequently he did so. �Reflecting the scientific and medical focus of SEAC, and the subject matter dealt with, he worked in close partnership with Dr Pickles and Dr Wight, both of whom were at different times observers to SEAC, throughout the relevant period.[45]
47. Mrs Whyte was a Higher Executive Officer within HEF (A) working under Mr Murray.[46]
48. In his statement to the BSE Inquiry, Mr Roscoe stated that DH acted as advisers to CSU on toxicity.� He stated that the DTI learnt in various ways about the possible hazards in cosmetics.� Normally they received advice from DH or reacted to reports in the press or to complaints made by members of the public.� The DTI together with DH then monitored them on an ongoing basis.� Whenever an ingredient of a cosmetic product �looked risky�, Mr Roscoe referred the matter to the DH, and they advised him what to do.� Mr Roscoe then decided what course of action to take.� As no one at DTI had any toxicity expertise, they relied entirely upon DH�s advice.[47]� The DTI always acted on the DH�s advice unless there were very strong reasons for not doing so.[48]� When the issue of BSE and cosmetics arose, this was the approach adopted by DTI.
49. Mr Roscoe stated that although Mrs Payne did have some contact with DH, Mr Roscoe was the main contact until his transfer to another Division of the DTI in February 1992.[49]�
50. Mr Roscoe also stated that Dr Fielder was his main contact at the DH, and that he referred everything to him.[50]
51. Ms Kelly, of the Cosmetics, Toiletries and Perfumeries Association (�CTPA�) has stated that in respect of advice from the Government, the CTPA would have received much of the contact by telephone.� Ms Kelly states that this is one reason why only limited records are now available.[51]
52. Ms Kelly also states, �Throughout this period the DTI Consumer Safety Unit (responsible for cosmetic legislation) kept the Association informed of any issue impacting on cosmetic safety and liased with other relevant DTI divisions and other Government departments.�[52]
53. In a memorandum to the Inquiry, DTI has said:
�An extensive search of our files has revealed very few papers relating to this subject.� This seems to be primarily because the Industry and the Department of Health were in direct contact, and the two sides were essentially just keeping us informed.� In addition, however, it was necessary for us to obtain briefing when this subject was raised, as it was on a few occasions, at the Cosmetics Working Party, an EU body set up to discuss matters related to the Cosmetics Directive.[53]
54. Mr Roscoe has stated in relation to the period when he was Grade 7 Head of the Chemical Hazards Section of the CSU:[54]
��I kept complete control of events taking place between the Department of Health, the industry and DTI.��
55. For much of the relevant period, a distinction was drawn for policy purposes between tallow, gelatine, and glycerol, which are the result of substantial industrial processing, and other bovine extracts.� Attention was directed at the latter, and in these areas the DTI sought advice from DOH.
56. As regards tallow derivatives and gelatine products used in cosmetics, the DTI stated in its memorandum to the Inquiry that before the European Commission decision of 27 March 1996 it accepted the view that there was no risk from tallow derivatives and gelatine products used in cosmetics. It based this view on the following factors:[55]
(i.) Assurances from MAFF that British beef was safe to eat which implied that there could be no risk from bovine products intended for external application.
(ii.) The belief that all material likely to harbour the BSE agent was being removed at abattoirs prior to processing as required by the Bovine Offal (Prohibition) Regulations 1989.
(iii.) The fact that the manufacturing processes for tallow derivatives and gelatine involved either high temperatures or aggressive chemical treatment or both � this was believed to deactivate any infective agent if present.
(iv.) The continued use of tallow derivatives and gelatine in food and pharmaceuticals.
(v.) Where appropriate, advice on specific proposals from toxicological advisers in DH.
(vi.) The recommendation from SEAC on 20 March 1996 that �the risk from eating beef is now likely to be extremely small� and the SEAC statement issued on 24 March 1996 that gelatine derived from non-specified bovine offal (non-SBO) material was safe to use in pharmaceutical and medical devices as well as food.
57. In relation to the use of gelatin Ms Kelly has stated:� �The use of gelatin in cosmetics is rare.� Most members using this ingredient were (and are) using pharmaceutical grade.�[56]
58. The DTI has said that it was not aware of any research into BSE conducted by the cosmetics or soap industry and that it had not conducted any research itself.[57]
59. In his Statement to the Inquiry Mr Roscoe said that in 1987-88 �From investigations carried out by the DTI�I knew that some cosmetics products did include offal.�[58]
60. In February 1989, the Report of the Working Party on Bovine Spongiform Encephalopathy (the Southwood Report) was published.[59]
61. The Interim Report of the Tyrrell Committee completed in June 1989 (published in January 1990) identified research into unrecognised routes of transmission of BSE to other species as being one of the highest priority research projects, and therefore gave it a three star rating. The cosmetics industry was specifically mentioned:[60]
�A1d. More detailed investigation into the fate of bovine (and ovine) tissues and products that could lead to infection being spread by as-yet-unrecognised routes.
Some uncertainty remains as to whether all the possible routes of transmission from bovine (and ovine) tissues to other species have been considered and appropriate action taken. Small scale users of bovine products, such as the cosmetic industry, may not be covered by the present regulations and guidelines. There are no formal proposals for work of this sort and consideration should be given as to whether such a study should be commissioned.�
62. On 20 June 1989, Mr Derek Andrews (Permanent Secretary, MAFF) wrote to Sir Donald Acheson (CMO, DH) to inform him that he had asked for a note to be prepared setting out the following for each of the research areas given three or two stars in the report:[61]
(i.) If the work was already in hand, where it was being carried out and what funding was being devoted to it.
(ii.) If the work was not already in hand, what funding was needed; to what extent it would be proper for the industry to fund it and who might do so; and, if it was most appropriate for the Government to fund, on whose budget it might fall - MAFF, DES or MRC.
63. Dr Shannon (Chief Scientist Group, MAFF), following extensive discussions with Mr Meldrum, Dr Watson and appropriate staff at the CVL, prepared a comprehensive document in response to Mr Andrews� request, on 30 June 1989. Project A1 d was included in �table 2� outlining work not in hand with suggestions for action.� In the column headed �Responsibility/source of funds/action� the table suggested �Further guidance should be sought from the Tyrrell Committee.�[62]
64. Clarification: The Inquiry also has a version of this document upon which, in relation to project A1d, that note has been crossed out by hand, and replaced with �Those routes currently considered important are being pursued.� Scientific progress may reveal the need for further action.� This issue is of importance also to DOH.�� We have been unable to identify the author of these hand-written annotations.�
65. A meeting chaired by Mr Andrews was held on 13 July 1989 to discuss Dr Shannon�s paper. A minute prepared by his PS noted that the following action was agreed:[63]
�(i)������� Dr Shannon would divide all the projects marked in the Tyrrell report with three or two stars into two categories: list A would set out with costing the projects which MAFF would be responsible for funding; list B would set out those projects regarded as falling to others to fund;
(ii)������� Mr McIvor would draft a letter for the Minister to write to the Secretaries of State for Health and for Education and Science, explaining that we had analysed the Tyrrell report, asking them to agree that we had no choice but to fund as an immediate priority all the work given three or two stars, and seeking their agreement to our breakdown between work we regarded as falling to MAFF and to others.� Further thought would be given later to work given one star in the report.� The letter would be copied to the Chief Secretary and would make clear how much extra funding the Minister would have to bid for in order to finance this extra research on BSE.� (Salmonella research would be treated in a separate letter).� Finally, the letter would enclose a draft statement for the Minister to make to Parliament announcing decisions on the implementation of the Tyrrell recommendations.�
66. On 21 July 1989 Mr McIvor circulated a draft letter for the Minister to send to the Secretary of State for Health, and a draft statement for the Minister to make to Parliament.� Table 2 appended to the submission had been amended in accordance with the handwritten annotations set out in para 64 above.[64]
67. On 5 January 1990, Dr Pickles sent a minute to Mrs Baxter stating that the Tyrrell Report was completed in June 1989, and that �there had been several months delay for MAFF to sort out financing of the research that was recommended.�[65]
68. Dr Pickles also stated that time had not been wasted since the report was completed.� She said that those who had needed to act upon its recommendations had had access to pre-publication copies, and that much of the high priority work was already in progress.� Dr Pickles then listed the �only two high priority topics that fall to us,� namely A2a � the monitoring of UK cases of the human equivalent of BSE, and C2a � concerning pharmaceuticals.[66] She enclosed a draft inspired Parliamentary Question prepared by MAFF which stated: �A number of the projects are covered by the substantial programme of research that is already in progress�Preparatory work is in hand on the other projects which the Committee recommended as urgent and of high priority.�[67] In her witness statement to the Inquiry Dr Pickles said: �I believed this to be the case in relation to A1d during the latter half of 1989 and the early part of 1990.�[68]
69. In his statement to the BSE Inquiry, Mr Roscoe says that he first made a connection between BSE and cosmetics in January 1990 after Professor Dayan (Professor of Toxicology at St Bartholomew�s Hospital and a member of the Medicines Commission) told him that normal industrial processes would not kill the BSE virus, and that using bovine offal in cosmetics carried the potential risk of BSE.[69]�
70. Mr Roscoe therefore wrote to the Department of Health in January 1990 (from memory he believes he spoke to Dr Fielder and then wrote to him) requesting advice on the use of bovine offal in cosmetics.[70]
71. On 26 January 1990 Dr Singh sent a minute to Dr Pickles and Mr Love (MCA), copied to Dr Fielder, attaching a draft reply to Mr Roscoe�s letter and a briefing for their comment.[71]�
72. On 29 January 1990 Mrs Shersby (MB1B/MCA) sent a minute to Dr Jefferys (Principal Medical Officer, MB3/MCA) copied to Dr Rotblat, Dr Raine, Dr Winship, Dr Purves, Mr Sloggem and Mr Love, all officials within the MCA, enclosing Dr Singh�s draft letter.� She requested comments on the letter and continued:[72]
�2. You will recall that the BSE Working Group decided at its meeting on 6th September 1989 that its recommendations applied to products in categories 7.1, 7.2 and 7.3 but not to those listed in categories 7.4, 7.5 and 7.6�This means that topical and oral products were excluded from the requirement, but that open wound dressings were included.
I shall be grateful if you will address the point about application of topical products to abraded skin, in particular.�
73. On 29 January 1990 Dr Pickles sent a minute to Dr Singh, copied to Mr Love and Mr Maslin.� Dr Pickles referred to a conversation about Dr Singh�s draft letter to Mr Roscoe, and stated:[73]
�I feel uneasy about permitting use of bovine offal from British calves under 6 months.� If there is a guarantee that any material derived from this is to be applied to intact skin only, then the hazard is so very remote it could be ignored.� But I sense difficulties in (1) being sure material will only be applied to intact skin (2) policing removal of these offal from only animals under 6 months and (3) consequent avoidable dangers to workers in the cosmetic industry.��
But I think application to broken skin is getting rather close to parenteral administration. Together with problems of policing the 6 month limit, and the fact that the �benefit� from such material is so dubious, I would prefer to see a complete ban.�
74. As the 6 month limit had already been agreed in Europe she stated� �I will not rock the boat the boat if you want to leave this alone for now� adding that she was sure that �MAFF would prefer this to be the case because of their current problems with BSE in Europe.�� She enclosed copies of her briefing note on BSE, the Southwood report (to pass on to DTI) and the Tyrrell Report (for his scientific colleagues).[74]
75. On 29 January 1990 Mr Sloggem replied to Mrs Shersby�s minute of the same date.� He said:[75]
�1.�� The advice from Dr Fielder seems fine to me.� There could be a problem with abraded skin providing a route of entry.� Spleen and placenta could well have high titres, assuming the analogy with scrapie holds good.� Sourcing abroad would seem the sensible thing to do.� Some tissues may have higher titres earlier than brain tissue eg gut, hence these are best avoided from British sources.
2.��� I see the briefing note mentions heating at 134-138� [2 atmospheres] for 18 minutes.� It should be made clear that autoclaving is intended.�
76. On 31 January 1990 Dr Jefferys, Dr Adams, Dr Raine and Dr Winship sent a minute to Mrs Shersby with their comments on Dr Singh�s draft.� They said that they were somewhat concerned with the draft letter, and made the following points:[76]
�First paragraph: No detailed information has been provided on the cosmetic products mentioned containing extracts of bovine offal, primarily spleen and thymus, therefore informed comment is not possible.
The CSM/VPC guidelines were framed in relation to licensed medicinal products where the risk/benefit analysis has been established.
Second paragraph: This is line with the current MCA position, which has been arrived at following the Southwood report, and the advice of the standing BSE Working Party, after reviewing the information provided by all Companies on their source materials and manufacturing processes.
Third paragraph: The wording of this paragraph will raise new concerns which cannot be scientifically answered.� We would ask that the third paragraph be omitted.
We feel there is an urgent need to clarify this issue and its implications for both MCA and MED TEH.� We therefore strongly advise that a meeting be held between MED TEH and MCA representatives to discuss overlapping areas of responsibility, before the reply to DTI is finalised.�
77. On 1 February 1990 Mrs Shersby sent a minute to Dr Singh proposing changes to his draft letter:[77]�
�Paragraph 1 � �������� to be unchanged
Paragraph 2 ����������� Reference to the use of cattle aged under 6 months is deleted.
Paragraph 3 - ���������� Will be replaced by the following:-
������ �We accept that the risk of transmission is very remote, but believe that it would be prudent to eliminate any risk from BSE, either by reformulating, so that the products do not contain any extracts of bovine offal, or if incorporation of bovine extracts is retained, material derived from cattle reared outside the UK, Eire and Channel Islands should be used.��
78. She added �our preference is towards material from Australasia� and indicated �we may reassess topical preparations in general and with specific relationship to human medicinal products before our next BSE Working Group meeting which is due to be held on 4 July 1990��
79. Following this consultation process, on 1 February 1990 Dr Fielder replied to Mr Roscoe�s request for advice, and attached the briefing note provided by Dr Pickles.� He said:[78]
�We accept that the risk of transmission is likely to be remote, but believe that it would be prudent to eliminate any risk by reformulating such products.� Alternatively if the incorporation of bovine extracts is retained, material derived from cattle reared outside the UK, Eire or the Channel Islands should be used.
We would be grateful if you would transmit these recommendations to industry via the Trade Association CTPA.
I attach background briefing prepared by medical colleagues from those sections most involved with consideration of BSE in DH, together with a copy of the Southwood report.�
80. On 1 February 1990 Mr Roscoe wrote to Ms Marion Kelly of the CTPA.� He said:[79]
�As you know there is no record of bovine spongiform encephalopathy crossing to humans, but we need to take precautions to avoid any risk.
There are a number of cosmetic products on sale in the United Kingdom such as anti-ageing creams that contain extracts of bovine offal, primarily from spleen and thymus.
The purpose of this letter is to ask you to ask your members to eliminate any risk by reformulating such products to eliminate these extracts, or alternatively to use material derived from cattle reared outside the UK, Eire or the Channel Islands.
Please let me know if you have any trouble persuading your members to do so.�
81. In her statement to the Inquiry, Ms Kelly states �When in 1990 the Department of Health expressed concern about lightly processed proteins (which were used in a very limited number of cosmetic products) the CTPA established that these products and ingredients were not manufactured in the UK and that imported products contained ingredients of non-UK-bovine origin.�[80]
82. On 2 February 1990 Dr Singh wrote to Mrs Shersby, copied to Dr Fielder, Dr Pickles and Mr Love, thanking her for the helpful comments and noting that the advice to Mr Roscoe had been copied to Dr Pickles and Mr Love.� He also said:[81]
�When we spoke a day or two ago, I said we would not wish to attend a BSE Working Group meeting unless relevant topics were to be discussed.� I note that the next meeting may consider topical preparations in which case we would welcome the opportunity to be present and look forward to receiving the agenda and papers.�
83. On 8 February 1990 Ms Kelly wrote to all members of the CTPA Perfumery Working Group, which comprised members marketing perfumery and premium skincare products:[82]
�� If you use any bovine offal extracts in your products I would be grateful if you could confirm that these materials are derived from cattle reared outside the UK, Eire or the Channel Islands.
This matter may attract further press enquiries, both to CTPA and to individual companies, and I would suggest that you alert your PR department and ensure that your technical services give this enquiry a priority.
The attached communication from DTI should be treated as highly confidential within your company.� [83]
84. The CTPA�s March 1990 newsletter contained the following in the �Blue Pages�:[84]
�Bovine Extracts
We would be grateful if any member marketing products containing such extracts would inform the secretariat (Debra Redbourn) with the following information:
Type of raw material e.g. tallow, gelatin
Type of product in which used
As soon as possible but no later than Friday 30 March.
This information is needed by the Secretariat to help it with any questions raised for a variety of reasons concerning such extracts.� It will also enable us to contact these manufacturers directly should there be a need to do so.
As usual all replies will be treated confidentially.�
85. In his statement to the BSE Inquiry Mr Roscoe said:[85]
�All mainstream cosmetic manufacturers were members of the CTPA.� The DTI did not have any knowledge of firms that were not members of the CTPA.� I cannot give an estimate on what percentage of firms were members of the CTPA, but their turnover would not be great.
No specific contact was made with the manufacturers that the DTI knew had used offal in their products in 1987/88.� We worked through the CTPA who contacted their members.
There was no means of contacting manufacturers who were not members of the CTPA, except by a press notice.� It would have been inappropriate in this situation to issue a press notice.� A press notice is a very crude instrument.� If we had used a press notice we would have possibly created a huge stir, as the media would have jumped onto the bandwagon and scared the public, creating an unjustified fuss.� In my opinion it is a serious flaw in the system that there is no complete list of cosmetic manufacturers and no way of contacting those manufacturers who are not members of the CTPA.
There are so many small manufacturers making cosmetic products, that in my view it would be impossible to compile a list of manufacturers who are not members of the CTPA.
�
We considered that the risk from cosmetics products thought to contain bovine offal was too remote to take action at retail outlets, or to attempt to establish the quantity in the pipeline.���
86. In his statement to the BSE Inquiry, Mr Roscoe also stated that he did not follow up with the CTPA to see what response they received from members because DH had advised that risk of transmission from cosmetics was remote, and therefore he did not consider that further follow-up action was justified.[86]
87. On 6 April 1990 Dr Pickles minuted Mr Lowson (Grade 5, Animal Health Division, MAFF) on the establishment of SEAC.� Dr Pickles asked whether they were going to raise the relatively minor matters of possible routes to man overlooked previously, such as the use of bovine ingredients in cosmetics, and the dissection of eyeballs.� She stated that if Mr Lowson were content she could put together very brief papers on these.[87]
88. On 11 April 1990 Mr Lawrence sent a minute to Mr Lowson, enclosing a chart identifying all the Tyrrell Committee�s recommendations for research and indicating the current position in relation to each one.[88] Project A1d, listed at 22, was described as funded by DOH/industry and� �not under way� and �not being undertaken at the present time.�� Mr Lawrence stated:
��
4. Hilary Pickles mentioned Item 22 and why DOH should be regarded as the main sponsor.� It is also down as a high priority which is not yet under way.� Ministers are sure to pick this up.� Perhaps a starting point would be for us to identify what materials leave an abattoir and for what use.� I am therefore copying this to Keith Baker and Chris Rogers for advice on where we should go to for this information.� Should we, for instance, talk to the Abattoir Owner Association?�
89. On 12 April 1990 Dr Pickles faxed a copy of a draft paper entitled �Routes of Possible Transmission of BSE to Man� to Mr Lowson.� The paper stated:[89]
�1.�� The Committee is asked to advise on whether there might be theoretical routes of transmission of BSE-infected material to man that have so far been overlooked.� In particular, advice is sought on (a) use of bovine material in cosmetics and (b)� .
�
3.��� The Consultative Committee on Research into Spongiform Encephalopathies in its interim report (June 1989) recommended that the range of destinations of all bovine parts leaving abattoirs should be determined, in case some of the tissues thought most likely to be infected were being used in ways that could present a hazard to man [see study A1d on p 10].� The cosmetic industry was mentioned.� This study has yet to be commissioned.� Indeed, a sponsoring body has yet to be found.
�
5.��� We have discovered some �cosmetics� on sale in the UK use extracts of spleen and thymus.� These products are said to have �anti-ageing� properties and although supposedly only administered onto intact skin, clearly broken skin could be exposed also.� Needless to say, there is no evidence of efficacy.� These products are not covered by the Medicines Act.� Advice given so far via the DTI to the appropriate trade association is that it would be prudent to reformulate to exclude bovine tissue.� Alternatively, if the incorporation of bovine extracts is regarded as essential, this material should be sourced outside the UK, Eire or Channel Islands.
6.��� Is the committee content with the line taken to date on cosmetics?�
90. On 23 April 1990 in a minute to Mr Lowson, Mr K Meldrum (CVO, MAFF) commented on Dr Pickles� paper. On cosmetics he stated:[90]
��it would not be reasonable to suggest that the material should be sourced outside the British Isles. At this time there must be some possibility that BSE exists in other countries in either a clinical or sub-clinical form bearing in mind their own scrapie incidence and the trading patterns in cattle and meat and bone meal from the UK to such countries.� An answer has to be found that takes cognisance of all these factors and does not simply classify the British Isles as an �infected area.� On that basis the paper needs considerable expansion to be helpful to the Tyrrell Committee.�
91. Apparently before receiving Mr Meldrum�s minute, Mr Lowson sent a letter to Dr Pickles on 24 April 1990, in which he stated, in relation to her proposed paper on the routes of possible transmission of BSE to man:[91]
��We can see no objection to this and the only reason why I did not include it in the bundle that I circulated last week was that I did not think that it was right to do so in the absence of final clearance from the author.� I should mention in passing that we were a bit surprised to read in paragraph 5 of the note that advice had been given to the relevant trade association on the advisability of incorporating bovine material in cosmetics.[92]� Such advice may well be right, but, as you rightly remind me from time to time, our two Departments need to keep each other informed of what we are doing; we have recently had to field a few enquiries on this point.
� .�
92. Upon receipt of Mr Meldrum�s minute on 24 April 1990, Mr Lowson faxed an annotated version of the minute to Dr Pickles.� He noted:[93]
�You will want to note Mr Meldrum�s comments above; I suggest you discuss with him any revisions.� I am afraid this overtakes the letter which I faxed to you a short time ago.�
93. Dr Pickles responded immediately to Mr Lowson, saying that she had seen the CVOs comments. She said that �in the circumstances, including what seems like a direction to you to only clear a much more detailed paper� that there was no alternative but to withdraw the paper from the agenda for the meeting of 1 May 1990.[94]� She added by way of explanation:
�� the line taken on cosmetics including sourcing from overseas was based on that given for licensed medicinal products by a group that included Drs Kimberlin, Watson and Will, as well as other MAFF officials.� There is no question that the UK is an �infected area�: the only question is whether other countries should be included too. The Licensing Authority, quite reasonably in my view, feels they can only insist on sourcing in countries where there is no evidence of BSE and the veterinary service and reporting system is adequate to detect it were it present.� Most manufacturers of mainline pharmaceuticals are not risking having to change sources yet again and so are looking to Australasia.� If the CVO thinks he has enough evidence, say concerning the USA, to persuade the CSM, CDSM etc to advise more strongly against sourcing there too, he should present that evidence in a convincing form and in writing.� I do not see this as a matter for our group, since there are statutory responsibilities under the Medicines Act.� What we should do is ensure consistent advice is given for those borderline products (like these �cosmetics� with medicinal claims) that currently fall outside that Act.�
94. SEAC met for the first time on 1 May 1990.[95]� The Committee considered Mr Lawrence�s table summarising research work being undertaken.� In relation to item 22 (project A1d), the minutes records:[96]
�MAFF and DOH would consider how to carry this work forward - it remains high priority.�
95. On 3 May 1990 Dr Pickles sent a minute to Dr Dastgir of PM.[97]� She stated:
� � in relation to item 22 on the chart, the committee were not pleased to hear that we had yet to agree who would commission this work.� The secretariat were left to sort it out.� It is �soft� research, so we cannot look to research councils.� The money would be very small.� I suggest we find it ourselves.� Provided you assure me you can do that, and tell me how much might be available - a few �k at most - then we can talk together and with MAFF about putting together a protocol.� I think the draft can be put together in house, but later we would need some expert advice too.�
96. On 3 May 1990 Dr Pickles also sent a minute to Mr Burton of PD.[98]� She attached a copy of her minute to Dr Dastgir and noted that the Tyrrell group was cross that nothing was being done about item A1d.� She asked whether PD had funds which might be used to commission the work, which might involve a relatively junior researcher for a few months at most.
97. On 9 May 1990 Mr Lowson sent a minute to Dr Pickles commenting on the draft minutes of the meeting of the Tyrrell Committee.[99] In relation to follow-up action, he said that he would pursue a number of additional points which he thought fell to him, including �arrange for Alan Lawrence�s table on research work to be updated periodically.�� The final paragraph included the following: �You and I will need to discuss how to carry forward work on unrecognised modes of BSE transmission � .�
98. Dr Pickles has stated to the Inquiry[100] that she attended a briefing meeting for Mr Gummer on 21 May 1990, at which he said that the A1d study should be immediately started �so that he could give Parliament what they wanted to hear and what he wanted to say.�[101]� Dr Pickles recalls that she told Mr Gummer she would start thinking about the protocol straight away, so that he could mention in all honesty to Parliament that all the work had �started.� In her witness statement to the Inquiry Dr Pickles said: �I think there was full understanding of those present that this was a device to ease a Ministerial statement, not a commitment from DH to sponsor this.�[102]
99. On 22 May 1990 Mr Lowson sent a minute to Dr Pickles[103] making some further points in relation to a revised version of the minutes of the Tyrrell Committee sent to him by Dr Pickles.� He attached a check list of action from the first two meetings of the Group and from �yesterday�s activity surrounding the debate� and asked �If there is anything that I have forgotten or got wrong (in particular if there is anything which you believe MAFF should be doing but which I have not recorded) please let me know.�
100. The attached check list included, under the heading �Agenda for future meetings� the topic �Dr Pickles� ideas on cosmetics, bulls eyes etc.�
101. On 4 June 1990 Dr Pickles sent a minute to Mr Lawrence providing comments on the MAFF draft memorandum for the select committee.[104]� In relation to Annex D (the list of research projects) she said �If item 22 (A1d) is now in progress please tell me about it - the advice to trade associations concerned cosmetics only, I think.�
102. On 7 June 1990 Dr Dastgir sent a minute to Dr Pickles.[105]� She stated:
��
2. The other DH areas of interest identified are - use of bovine materials in pharmaceuticals etc.� As you know MAFF have indicated (in A J Lawrence minute 11/4/90 - Spongiform Encephalopathies: Tyrrell Recommended Research item 22) that they consider these should be DH funded research.� This item is still outstanding and may have MAFF ministerial support.� In view of your briefing to CMO for 20 June Agriculture Select Committee meeting, would you please indicate if there is still a need for research commissions for us in this area. �With economies for research funding that are now needed due to pressure on our budgets, this source is worthy of further consideration perhaps by Will. It will be important for RMD to discuss these issues with you further as necessary but RMD requires an urgent response re item 22�
103. Dr Pickles replied to Dr Dastgir on 8 June 1990 by way of a handwritten note which stated:
�There is an urgent need for this work (no 22) to be commissioned, but Mr Gummer at a meeting with me on 21st May said MAFF would fund it.� Please contact your MAFF opposite number to confirm this is actually happening.�
104. On 9 June 1990 Dr Pickles forwarded to Dr Dastgir a copy of her minute to her of 3 May 1990, to which she had added the handwritten note:
�Following on from my minute of 8.6.90, in response to your recent minute, you will remember this of mine from 3rd May.� I did not get a response (nor from PD either it must be said.)�[106]
105. On 11 June 1990 Dr Pickles wrote to Mr Bradley about some concerns she had about the significance of BSE.[107]� She stated at paragraph 9:
�9. This ties in with my concern that we do not really know what happens to all the parts of cows.� � This was raised in the Tyrrell report as A1d.� When Mr Gummer found this was still not being attended to, he gave a firm instruction the study should be started and I presume you have this in hand and that MAFF will be providing the funds.� Please let me know if you need any help with the protocol.�
106. On 14 June 1990 Mr Smith (RMA1) wrote to Dr Pickles about research recommended in the Tyrrell Report.[108]� He referred to project A1d, and stated, �Following your exchange of minutes with Dr Dastgir, I have confirmed with MAFF (Mr Lawrence�s office) that MAFF/DTI are to fund [A1d].� They will send me the latest version of the list of projects showing this.�
107. Mr Bradley�s reply to Dr Pickles� minute of 11 June is dated 17 June 1990 (but he stated that although he started the letter on 17 June, it was not finished until much later).[109]� He stated in relation to A1d:
�I have not got far with this.� Where do fetal calves, placenta and uteri go and are any uses made of lymph nodes?� Cosmetics, ointments, oils, indeed anything that is used on the skin (it could have a lesion) could present an increased hazard.� I have some concern over mesenteric lymph nodes though they are not eaten, though DOH/MAFF agreed earlier there was no need to include them in the offal ban.� This is one to discuss in Committee.�
108. On 22 June 1990 Mr Otley (EHF3) provided a submission to Mr Yates (PS/PS(H)) providing briefing prior to the Agriculture Select Committee hearing of 27 June 1990.� This was copied to, among others, Dr Pickles.� Annexed to the submission was a memorandum prepared by MAFF for the Agriculture Select Committee, which included a revised version of Mr Lawrence�s table of research projects.� Item 22 was now listed as funded by DTI, MAFF and Industry, and the table stated that the project was �In progress.� Advice given by DTI to trade associations in relation to cosmetics.� Investigations under way to determine other outlets for bovine and ovine tissues.�[110]
109. On 25 June 1990 Dr Pickles sent a note to Dr Metters attaching a note he had requested �with examples of difficulties in MAFF, BSE research.� [111]The attached list was headed �AREAS OF RESEARCH falling to MAFF to fund, and where delays and difficulties have been experienced.�� The list included, at point 5 �OTHERS: where progress (if any) uncertain or delayed, in spite of the importance � (b) survey of all outlets for bovine tissue � .�
110. On 4 July 1990 the BSE Working Group of the Committee on Safety of Medicines met.� The Working Group was chaired by Professor Collee.� Also present at the meeting were Professors Campbell and Lawson, and Drs Kirby, Minor, D Taylor, Kimberlin, Tyrrell and Watson (of whom the last three were members of SEAC).�� Amongst the items for discussion were topical products, both medicines and cosmetics.� The Working Group had before them a paper on this subject dated June 1990 prepared by Dr Winship,[112] which attached a copy of Dr Fielder�s reply to Mr Roscoe of 1 February 1990.� The minutes record the following:[113]
�10. Topical Products - Medicines and Cosmetics
10.1 Following a request from the Department of Trade and Industry for advice on the safety of the use of extracts of bovine offal in certain cosmetics, a reply was sent by Dr R J Fielder, Med TEH, Department of Health on 1 February following consultation with Med ISD and the MCA.� It is recommended that the products should be reformulated or if the incorporation of bovine extracts is to be retained, material derived from cattle reared in BSE-free areas should be used.
10.2 Topical administration of licensed medicinal products containing bovine materials has already been discussed at the BSE Working Group Meeting in September 1989.� They were not considered to be a cause for concern at that time and this position is unchanged.
10.3 In view of this more recent concern about the use of bovine offal in cosmetics, it was considered advisable to look into topical use in relation to medicinal products.� Such use appears to be confined to products by [redacted] and [redacted] and the source of the material is Germany.� No further action is currently required by the MCA in relation to licensed medicinal preparations.���
111. On 7 March 1991 SEAC held a meeting. [114]�� Mr Murray had by this time replaced Dr Pickles as DH secretary to SEAC (he was in post for its fifth meeting on 19 September 1990).[115] On 15 March 1991, Mr Lowson wrote a minute entitled �Tyrrell Committee: Follow up to 7 March meeting.� [116] This included the following:
��
(iii) Non-food uses of bovine material.� The Committee asked for a note on the use of bovine material for cosmetics in particular, although it might make sense to cover all the non-food uses that we can think of (harp strings, tennis rackets etc).� I think that all that is required is a factual note about the range of uses, and quantities, together with an assessment of possible risk factors. It looks to me like a job for Dr Pickles.
��
112. In a minute to Mr Maslin (MAFF) on 25 March 1991, Dr Pickles queried the status of the research into non-food uses of bovine by-products highlighted as a priority in the June 1989 Tyrrell report.� She asked:[117]
��Who is doing the study identified in the Tyrrell report A1d?� Your Ministers have claimed all the 3 star projects are being taken forward.� The MAFF summary chart gives this item as being done by �DTI, MAFF, Industry�.� Please let me know how it is going on and who are the relevant contacts.�
113. On 8 April 1991 Mr Bradley prepared a hand-written minute, apparently to Stephanie Townsend, entitled �Non-food uses of Bovine Material.�� This stated:
�I refer to Dr Pickles� minute to Mr Maslin.
I have questioned this before and have no hard evidence to offer.� My notes suggest action on Aid (Tyrrell Report) to be a joint DOH/MAFF responsibility.� Within MAFF my notes suggest that commodities divisions have had some responsibility but I cannot identify which.� I also have a heading entitled �MURPHY� but do not know its significance now.
Non-food uses of bovine material �off the top of my head� would include:
- �
- tallow in industry
������ in non-medicinal ointments
������ in cosmetics.
- gangliosides (from brain) for cosmetics and biologicals.
�
The Tyrrell para referred also to ovine tissues and to �ROUTES OF TRANSMISSION.�� I believe we can consider these under:-
�
5 - cosmetics and other topical applications as yet unlicensed.
�
5 Definitely use gangliosides in some instances.� This was referred to in my Annecy report of 1990.
�
COSMETICS AND OINTMENTS
These have a potential risk depending on ingredients and [illegible] as they can be applied repeatedly (daily) and could enter the body through cuts.� When I brought this up before I was informed by I believe Alan Lawrence that DTI was responsible for this aspect.�
114. On 23 April 1991, Mr Maslin replied to Dr Pickles� minute dated 25 March 1991.[118]
�I apologise for not coming back to you earlier but we have been trying to find out what has happened to this study.�
From our papers it would seem that there has been no �study� initiated.� The reference to �DTI, MAFF, Industry� was I assume included in the summary chart in the early days and has simply been perpetuated in later charts. Alan Lawrence recalls that this was a matter raised with Mr Gummer before the BSE Parliamentary debate last year.� It seems however that this area has fallen through the cracks.�
115. On 24 April 1991, Dr Pickles replied to Mr Maslin.� She stated: [119]
�1.�� I find your response quite unsatisfactory.
2.��� When we were discussing last year with Mr Gummer and MAFF officials were writing into a speech that all essential research was being funded, I pointed out this *** project identified by the Tyrrell research committee was not being taken forward.� Mr Gummer�s response was that it should be immediately so that he could give Parliament what they wanted to hear and what he wanted to say.� I have asked about the project several times since and been reassured.� You now tell me that nothing has happened.
3.��� Do you really want to come clean in front of the next meeting of the Tyrrell committee, or do you want more time to prepare your case?� Of course, I could make a start at a �list�, but the purpose of a research study was to investigate more formally as to what actually happens, not what some of us think might happen.�
116. Mr Lowson was copied Dr Pickles� minute of 24 April 1991, and responded to her on 26 April 1991:[120]
�I entirely agree that it is not satisfactory that this item on the Tyrrell shopping list should not have received the attention it deserved. �� As to why this has happened, Alan Lawrence and I both have a clear memory that at the briefing meeting with Mr Gummer for the House of
Commons BSE debate last May you were kind enough to raise with him the question of what was happening about this study and then agreed to go away and draft a protocol as quickly as possible.� It was a hot afternoon, a long meeting and nobody produced a note so I would not want to be too critical of the fact that nothing seems to have happened as a result.�
Commons BSE debate last May you were kind enough to raise with him the question of what was happening about this study and then agreed to go away and draft a protocol as quickly as possible.� It was a hot afternoon, a long meeting and nobody produced a note so I would not want to be too critical of the fact that nothing seems to have happened as a result.�
117. On 29 April 1991 Dr Pickles replied to Mr Lowson�s minute of 26 April 1991.� She stated:[121]
�1. We discussed briefly your note of today�s date and agreed that we now did not have time to bring this to the next Tyrrell meeting.
2. I agree that to satisfy Mr Gummer that the matter was being taken forward I said I would be thinking about the protocol that afternoon since there was no professional from MAFF present at the time who could volunteer in stead.� But the tables provided thereafter by MAFF indicated that �DTI, MAFF and Industry� was carrying this forward and in correspondence with Mr Maslin I made it clear it was not really my responsibility.
3. Irrespective of what should have happened, how do we take this forward?� Would the right approach be to provide a paper for Tyrrell and put our own attempt at a list in, and ask them whether a formal study should be commissioned?� If so, who would pay?� The money will be trivial.� Is it DTI, MAFF, HSE, DH or the �agriculture� industry?� Or do we quietly drop the idea of a study and hope none of them remember the Tyrrell research report (some chance!).�
118. The BSE Inquiry has been unable to trace a response to this letter or any continuation of correspondence on this point.� However, on 2 May 1991 Mr Lowson wrote to Dr Tyrrell regarding the agenda for the next meeting of the Tyrrell Committee.� He stated:[122]
��
Third, I am afraid that we have not made much progress on the question of the non-food uses of bovine material.� We may be able to table some basic information, but only I think for a preliminary discussion.
��
119. A meeting of SEAC took place on 10 May 1991, the minutes record:
�K NON-FOOD USES OF BOVINE MATERIAL
21. MAFF would circulate to members a list of such uses that had been drawn up in consultation with the slaughtering industry.� It would make sense in addition to seek from the cosmetics industry an indication of whether they used bovine material.�[123]
120. On 13 May 1991 Mr Lowson circulated a minute entitled �Tyrrell Committee: 10 May: Follow-up� which included the following:[124]
��
(iv) Non-food uses of bovine material: Could Mr Rhodes please tidy up the list that was faxed to me during the Committee meeting and send it to members.� It was agreed that information should be sought from the cosmetics industry about whether they use bovine material and I suggest that Mr Murray pursues this.
� .�
121. On 22 May 1991 Mrs Townsend (Animal Health (Disease Control) Division) sent Mr Murray a copy of a list of uses of bovine material, at Mr Lowson�s request.[125]� The list was entitled �Treatment of By-Products of Bovine Slaughter.�
122. On 29 May 1991 Dr Pickles sent a minute to Dr Raine (MCA), Mr Burton (MDD), Dr Nugent (ISPA) and Mrs Shersby (MCA), copied to Mr Murray and Mr Lister, regarding non-food uses of bovine material.[126]� She attached the list prepared by MAFF entitled �Treatment of By-Products of Bovine Slaughter� and stated:
�The Tyrrell Committee is now into the small print of trying to work out how possibly BSE-infected bovine material might get into humans.� I need your help with lateral thinking.� MAFF have drawn up the attached list, based on bits collected from slaughterhouses.� It does not include placentae, for example.
2.��� We have already identified use of bovine lymphoid in cosmetics as a topic worthy of attention.� We are well aware of the use of bovine serum, albumen and fetal calf serum in laboratory studies (as well as pharmaceuticals).� Are you aware of any other uses of bovine materials not listed here?� Even if there seems no direct contact of the product with humans at the end of the road, there may be concerns for the workers handling the material, so news of anything else you can think of (however minor the use) would be appreciated.� Material used in licensed medical products is controlled separately, so need not concern us here.
3. If you can respond by 14 June, so much the better. Please copy to anyone else who might have bright ideas on this.�
123. On 3 June 1991 Mrs Shersby copied Dr Pickles� minute of 29 May to Dr Purves, Dr Matthews, Mr Sloggem and Mrs Baker.[127]
124. On 17 June 1991, Dr Pickles sent a minute to Mr Lowson, attaching a paper on use of bovine material in non-food products, and asking whether this was the sort of thing they were proposing to put before the Committee.[128]� She also asked whether someone was getting more detail about cosmetics, noting that Mr Lowson�s note of 13 May suggested that this was to be Mr Murray, but stating that she had not heard from Mr Murray what, if anything, he had done on this.
125. On 19 June 1991 Mr Lowson replied to Dr Pickles� minute of 17 June.[129]� He stated that he thought the draft paper was perfectly adequate to focus the Tyrrell Committee�s thoughts on the issues.� He noted that Ray Bradley had suggested two further items, and that he believed that there might be yet further items, such as placenta, which Mr Bradley believed was used in cosmetics.� Mr Lowson stated that he and Mr Murray had discussed the point about cosmetics, and that Mr Murray was following it up.� He asked Dr Pickles to finalise the paper with Mr Murray, to be numbered SEAC9/2.
126. Dr Pickles faxed Mr Lowson�s reply of 19 June to Mr Murray the same day.� She said that she had added the two new items and altered the code number.� If Mr Murray was content, she asked him to circulate the paper.[130]
127. On 25 June 1991 Mrs Whyte minuted Mr Murray in response to a request to make enquiries of the trade organisation representing the cosmetics industry into the use of bovine material.� She informed him that Dr Gott in MED TEH (who had policy responsibility for cosmetics) had given her CTPA�s name as the trade organisation with whom he liaised and Mr Ian Phillipson as the contact.� Dr Gott had also faxed across copies of the correspondence that had taken place with DTI in February 1990.� Mrs Whyte continued:[131]
�In Mr Phillipson�s absence I spoke to his assistant Mrs Deborah Redborne.� She has looked out their file on this subject and can find nothing further to the 1990 correspondence.� However she confirmed that the DH advice on bovine material was issued to the cosmetic industry through an article in their trade journal written by Mr Phillipson.�
I will speak to Mr Phillipson tomorrow when he returns to check the latest position.����
128. On 26 June 1991 Mrs Whyte minuted Mr Murray again after speaking with Mr Phillipson.� Mr Phillipson had told Mrs Whyte that following the receipt of the DTI letter in February 1990 advice was issued to the cosmetics industry through the �CTPA Scientific News.�� Mrs Whyte said:[132]
�The advice was also discussed at the CTPA European Scientific Committee so international interests have been covered.� A copy of the article in the scientific journal is attached for our reference.� Mr Phillipson confirmed that the advice stands and that the industry has acted on it.� The correspondence from DTI did not mention ovine material so this has probably not been covered (if used).�
129. It appears that two papers were prepared for SEAC.� The first was prepared by Dr Pickles and numbered SEAC 9/2.[133]� It was entitled �Use of Bovine Material in Non-Food Products� and had attached the list prepared by MAFF.� It was circulated by Mr O�Neill to the members of the Tyrrell Committee on 21 June 1991, at Mr Murray�s request.[134]� This paper stated that although a formal study had not been undertaken, the attached list had been drawn up.� It stated that the questions for the Committee were whether the list was complete, and whether these or other, unlisted, uses of bovine material presented any risks to public health or the health and safety of the workers concerned.� A certain amount of discussion then followed.
130. �A second paper, entitled �Use of Bovine Material in Non-Food Products: Cosmetics,� numbered SEAC 9/2A, was prepared by Mr Murray.[135]� A hand-written note on the document, initialled RL and dated 2/7, notes �Tabled at SEAC 28/6.�� This paper dealt specifically with the position in relation to cosmetics. The paper summarised the action taken in relation to cosmetics to date. It referred to the DH letter of 1 February 1990 to the DTI (a copy of which was attached together with the background briefing provided to Dr Fielder by Dr Pickles) and the publication of this advice in the February 1990 edition of �CTPA Scientific News�.� The advice was said to have been the subject of discussion at the CTPA European Scientific Committee.� The note continued:[136]
�The CTPA claim that their members have received the advice and acted upon it. However, the CTPA has no detailed information on the present use of bovine material, DH cannot therefore be sure all CTPA members have received and adhered to the guidance. Similarly, there is uncertainty about the practices of small scale producers who do not have CTPA membership.�
131. The minutes of the meeting of SEAC on 28 June 1991 record:
� �F NON-FOOD USES OF BOVINE PRODUCTS
21. The Committee considered papers SEAC 9/2 and 9/2A.� In general it appeared that no problems arose but the following points should be pursued:
- check whether contact lens care products were covered by CSM guidelines
- investigate whether any specified bovine offals going for industrial use and hence exempt from sterilisation and staining regulations were likely to end up in products (e.g. cosmetics) which might come into contact with human tissues; and
- remind DTI that as BSE had now been found in other countries their guidance to cosmetic manufacturers should be updated in regard to scrutiny, and importation of prepared cosmetics.[137]
132. Hand-written notes made by Mr Murray on SEAC 9/2 state:[138]
�Mr Lowson to check the release of specified offal for manufacturing process.
Query imports of offals from continent.
Revised guidance to DTI.�
133. On 30 June 1991 Mr Bradley sent Mr Lowson a hand-written note in which he referred to the letter of 1 February 1990 from Dr Fielder to DTI and to the background briefing [presumably Dr Pickles� background briefing, which was sent to DTI with Dr Fielder�s letter: see para 79 above]: [139]
�In regard to the former I understand (and recommend) the Secretariat will inform DTI about BSE in France and Switzerland.� Also to look into imports of cosmetics using ingredients from cattle originating in those countries.�
134. On 3 July 1991, Mr Lowson prepared a note concerning follow-up to the Tyrrell Committee meeting on 28 June.� In relation to non-food uses of bovine material, he noted:[140]
�The Committee were concerned about a number of issues:
- to update the advice from DTI to the cosmetics industry to take account of the existence of BSE in other countries (can Mr Murray please pursue);
- to investigate whether contact lens care products are covered by CSM guidelines (I understand Dr Pickles is pursuing); and
- to find out whether any sbo�s which are exempted from the sterilisation and staining regulations for industrial use might end up in products for human use.� Can Mr Lawrence please investigate.�
135. On 24 July 1991 Mr Murray sent Dr Pickles a minute referring to the SEAC meeting of 28 June 1991. Mr Murray asked Dr Pickles to review the previous advice to the DTI and suggest amendments as necessary.� He suggested, �reference will have to be made to BSE in France and Switzerland and the ingredients from bovines from these countries.�[141]
136. On 25 July 1991, Dr Pickles replied to Mr Murray�s request.� She agreed that the geographical aspects needed updating.� She said �[the] background briefing is not really appropriate in that form (it was not something I had intended should have gone to DTI in any case).�� She also suggested that it could be pointed out that there were potential concerns:[142]
�*��� for workers in the cosmetic industry who may be exposed frequently to these materials, especially if inoculation injuries might occur and
*���� those who by repeated application particularly to thinned, scarified or diseased skin might absorb material including infective agent that way, also
*���� there may still be some strange products administered by injection that are trying to evade the Medicines Act by calling themselves cosmetics.� If any of those involve bovine ingredients, they need to comply with the CSM guidelines.�
137. Dr Pickles also noted that the fundamental concerns were well described in previous papers/briefing etc and were essentially unchanged from those expressed in the Southwood report.� She said that in addition to EHF3 writing to the DTI, DH should ask to be kept properly informed of any action that followed.� They needed reassurance that the message had reached the right people. She questioned whether fringe companies were members of trade associations, and, if not, whether information was reaching them, and whether the DTI had accepted it was their responsibility to keep such manufacturers informed.[143]
138. In August 1991 a letter was drafted to Mr Roscoe by Mrs Whyte along the lines suggested by Dr Pickles.[144]� Mr Murray, the proposed signatory, made some hand-written amendments.
139. CLARIFICATION: The BSE Inquiry has been unable to locate any final letter sent to Mr Roscoe.� Is there any record that this letter was or was not sent to Mr Roscoe?
140. On 5 August 1991 Mr Bradley minuted Mr Lawrence about cosmetics. He said: [145]
�I have the feeling we are far too remote from the industry to make meaningful comments.� Contacts via DOH/DTI do not inspire me with confidence.� I would advise we need to know what bovine materials are really used in cosmetics and for what purposes.� We either need to send someone into the industry (as I did for tripe, casings and rennet) or have a closer contact via the trade association.� I am not satisfied yet that the industry is �in the clear� and it is us that may shoulder some blame if it is later found ladies are rubbing cow brain or placenta on to their faces.� It may not be our job but if we have any responsibility we need to get at the facts.�
141. In his statement to the BSE Inquiry Mr Roscoe commented:
�I have not seen the minute between Mr Lawrence and Mr Bradley before�. This minute states� �contacts with the DOH, DTI do not inspire me with confidence�.� I do not agree with this comment.� I am satisfied that the DTI and the DH did everything they could, the only flaw in the system is that we could not reach all manufacturers.�[146]
142. During August 1991 Animal Health (Disease Control) Division [Mr Lawrence] prepared a note for SEAC[147] entitled �Use of Specified Bovine Offal.�� The note outlined existing controls on the movement of SBO, and continued:
�Cosmetics
3.��� In February 1990 the Department of Health wrote to the Department of Trade and Industry, following a request for advice on the safety of using extracts of bovine offal in certain cosmetics.� Placenta is used for its supposed anti-ageing properties. Gangliosides, spleen and thymus may also be used, although there is no firm knowledge on this.
4.��� DTI issued advice to the industry, via the Trade Association, to the effect that even though the risks were remote it would be prudent to reformulate these products or source from countries free from BSE.� In this context it was agreed at the Tyrrell committee meeting on 28 June that DTI would be reminded that since BSE had been found in other countries their guidance to cosmetic manufacturers needed to be updated.
�
Consideration and Conclusion
7.��� � Guidance has also been issued in relation to cosmetic use and we have no reason to believe that the major manufacturers have not followed the advice given.� However in order to obtain as definitive a picture as possible it is considered advisable to check with the trade association to see if this is the case and whether there are small companies who are not members and may not therefore be aware of the advice given.� A further check could also be made through the abattoir owners as to the destination of by-products.�
143. On 21 August 1991, Miss S B Jones (Meat Hygiene Division, MAFF) sent proposed amendments to the Bovine Offal (Prohibition) (Amendment) Regulations for comment to various organisations and interested parties.[148]
144. On 6 September 1991, the Animal Health (Disease Control) Division paper �Use of Specified Bovine Offal� was tabled at the tenth meeting of SEAC.[149]� The minutes do not record any discussion of the paper.
145. On 15 October 1991 Mrs Whyte minuted Dr Wight. She said:[150]
�1. Mr Murray asked me to copy to you our papers on the use of bovine material in cosmetics in connection with the attached article sent to us by John Maslin, MAFF. The article appeared in a recent Mail on Sunday supplement and states that �sheep�s placenta and cow�s brain tissue are included in (cosmetic) treatment products as �fresh cells� and �biological extracts�.
2. We have been looking at the use of bovine material in cosmetics and other non-food products, and the subject has also been discussed by the Tyrrell Committee. The Department issued advice to the cosmetics industry, via DTI, on the use of bovine material in cosmetics in February 1990. This advice suggested that the use of extracts of bovine offal should be discontinued. Alternatively material should be imported from cattle reared outside the UK, Eire and the Channel Islands.
3. Follow up enquiries of the Industry�s Trade Association indicate that manufacturers were asked to check with their suppliers the origin of any bovine material used. However, there is no detailed information on the present use of bovine material and we cannot be sure that the DH advice has been widely received or adhered to. Also we do not know about small scale operators who are not members of the Trade Association.
4. When this was discussed by the Tyrrell Committee in June, it was agreed that the DH should reconsider its earlier advice to DTI with a view to re-issuing it.
5. When you have had a chance to look at the background papers Mr Murray would like us to get together urgently to consider this further. Perhaps you can let me know if it is possible for us to meet sometime this week? I look forward to hearing from you.�
146. On 31 October 1991 Dr Wight minuted Mr Murray about ruminant-derived material in cosmetics.� The minute appears to be a draft update of the advice given to the DTI.� The minute said the following:[151]
�The Department of Health wishes to reinforce the advice given to the Cosmetics Industry in February 1990 (ref.)
It is possible that some ruminant-derived materials are being incorporated into cosmetics or beauty treatments which are then marketed as �natural� products.
The particular materials that should not under any circumstances be used in the manufacture of cosmetics or beauty treatments are:
1.bovine (cattle) derived offals, or proteins derived from these offals.� These offals are: brain, spinal cord, spleen, thymus, tonsils, intestines (Bovine Offal (Prohibition) Regulations)
2. ovine (sheep) � derived offals and ovine placenta.
In view of the current uncertainty about the incidence of infection with spongiform encephalopathy agents it is probably advisable that these recommendations apply to the above ruminant-derived materials of any country of origin.�
147. A hand-written note (author unknown) at the bottom of the page states �this could go in trade rag(s)�.� The Inquiry has been unable to ascertain what became of this advice.
148. On 6 November 1991 Mrs Whyte minuted Dr Wight about the draft Bovine Offal (Prohibition) (Amendment) Regulations. She said:[152]
�2. Tom Murray is concerned with two points raised in the draft Regulations and would appreciate your views. They are as follows:
(i) Section 2(a)(ii)(b) states that �premises used for the manufacture of products other than food or animal feeding stuffs�� will be designated as excepted premises. Do you know if they are covered by other regulations (ie CSM advice) and what about cosmetic manufacturers? ��
149. Mrs Whyte also asked whether Dr Wight �could let us know how far you have got with the advice note on the use of bovine material in cosmetics?�
150. A hand-written comment on the minute, author unknown, said:[153]
�I don�t think these bovine or other animal derived products should enter cosmetic or other such industries at all. Don�t know about other Regs.�
151. On 13 November 1991 Miss Jones (Meat Hygiene Division MAFF) sent a minute to Mr Turner of the Legal Section,[154] about DH concerns on the use of specified bovine offal (SBO) by the cosmetics industry. DH wanted to use the Bovine Offal (Prohibition) (Amendment) Regulations to impose a ban on the use of SBO in cosmetics. This measure was felt to be necessary, as it seemed the advice issued by the DTI in February 1990 was not being followed universally.� Miss Jones felt that as the SBO regulations were made under the Food Safety Act 1984, �they would not be an appropriate or legitimate means of introducing such a ban�.� As she understood it, �the Act is concerned solely with ensuring that food which reaches the consumer is safe to eat and it could not therefore provide a legal basis for a prohibition relating to cosmetics�.� She asked if Mr Turner could confirm that this was the case.� If so, then �it would presumably be up to DOH to introduce the ban under other legislation.�
152. Miss Jones wrote to Mr Murray on 25 November 1991.[155]� She said:
�Following discussions with Mr Baker and myself it emerged that you had three areas of concern in relation to the�Regulations. �
�Your first point related to the definition of �excepted premises� (Regulation 2).� You expressed concern that certain sectors of the cosmetics industry are still using specified bovine offal in the manufacture of their products and you wished to see the definition amended to exclude such premises.� Indeed you would prefer to see the Regulations used as a vehicle for introducing a total prohibition on use of SBO in cosmetics and, perhaps, certain other non-food products.� While I understand your concern over this issue, our legal advice is that the Food Safety Act 1990 (under which these Regulations are made) would not be an appropriate means of introducing such a ban.� The Act is concerned solely with ensuring that food which reaches the consumer is safe to eat and could not therefore provide a satisfactory basis for action in relation to cosmetics or similar products.� In light of this you may wish to consider whether there is other legislation available which would provide a more appropriate basis for taking such action.
��
153. On 9 December 1991 Mr Murray replied to Miss Jones� minute regarding the proposed amendments.� He said:[156]
��
I accept the point you make on the first two amendments that we cannot use powers under the Food Safety Act to control the non-food use of �specified offal�. �
I have briefly discussed with Robert Lowson the need to control the non-food use of specified offal.� He and Dr Tyrrell (Tyrrell Committee) are sympathetic to the suggestion.� I will discuss further with Robert how we take forward such action.
��
154. On 19 December 1991, Mr Lewis Baker (Meat Hygiene, MAFF) distributed a revised draft of the submission, regulations and press release for comment to, among others, Dr Pickles and Mr Murray.� This was stated to be necessary because of the volume of comment received after the last circulation.[157]� By this time Dr Wight was acting as DH observer to SEAC.
155. On 28 January 1992 Mr Murray minuted Miss Bloomfield, the APS to the Parliamentary Secretary for DH, attaching a submission on the proposed regulations, and recommending �PS(H)�s acceptance of the Regulations.�[158] The submission said, at paragraph 9:[159]
�Concern has been expressed, both within the Ministry and by the Department of Health, about the use of specified bovine offal in certain non-food products, particularly cosmetics. It has, however, been agreed that the Bovine Offal (Prohibition) Regulations would not be a suitable vehicle for introducing a prohibition on such use.�
156. On 28 February 1992 Mrs Whyte minuted Dr Wight in connection with �our proposed approach to the Cosmetic, Toiletry and Perfumery Association about the use of bovine material in cosmetics etc.�� She attached a list of suggested questions to put to the CTPA and said �[t]he outcome of this exercise could then determine whether a meeting was needed with possible guidance issued later.�[160]� Mrs Whyte asked Dr Wight to let her know whether the list was acceptable.� She indicated that they could write to the CTPA �fairly quickly� once the questions had been agreed, and said that she would copy any correspondence to MAFF �to keep them informed of our action.�
157. On 1 April 1992, Mrs Whyte minuted Mr Murray attaching a draft letter to Mr Phillipson of CTPA seeking additional information on the use of bovine material in cosmetics.� Appended to the letter was a questionnaire the contents of which had been agreed with Dr Wight.� Mrs Whyte said that if Mr Murray was content with the draft, she would arrange issue.� A hand-written comment on the page, written by Mrs Whyte, states �draft amended.�[161]
158. On 2 April 1992, Mrs Whyte wrote to Mr Phillipson of the CTPA.� After mentioning the advice issued on 1 February 1990 and the CTPA�s dissemination of it to members, she continued:[162]
�As it is some time since the Departmental advice was issued it is possible that some ruminant-derived materials are again being incorporated into cosmetics or beauty treatments which are then marketed as �natural� products.� As an example, an article on �natural beauty products� has appeared in a Sunday supplement which stated that �sheep�s placenta and cow�s brain tissue are included in (cosmetic) treatment products such as �fresh cells� and �biological extracts�.� This is exactly the type and use of product about which the Tyrrell Committee was concerned.� The particular materials which should not, under any circumstances, be used in the manufacture of cosmetics or beauty treatments are:
1.��� Bovine (cattle)-derived offals, or proteins derived from these offals, such as: brain, spinal cord, spleen, thymus, tonsils, intestines.� These are the specified offals covered by the Bovine Offal (Prohibition) Regulations 1989.
2.��� Ovine (sheep)-derived offals and ovine placenta.�
159. In addition the CTPA were asked to complete an attached questionnaire in �an attempt to gauge the extent to which bovine and ovine material may be used in the production of cosmetics and beauty products.�� This letter was copied to Dr Wight and Dr Fielder.
160. On 14 April 1992 Ms Kelly replied on behalf of CTPA to Mrs Whyte, saying that it would not be possible to obtain answers to the questions posed by 24 April, as the cosmetic products were manufactured in the UK, the EU and non-EU countries.� Ms Kelly suggested that the following points might be relevant to discussions on 24 April:[163]
�* �� The use of animal derived �cell/biological extracts� is largely confined to the premium end of the market i.e. expensive facial care treatments.
*���� These products are marketed mainly by French and US based companies, who manufacture mainly in those countries.
*���� In response to a request from DTI in February 1990 we wrote to member companies whom we considered would be most likely to be affected.� The members who replied indicated that the material they used did not originate in the UK, Eire or the Channel Islands.�
161. Ms Kelly also stated that on �the basis of our knowledge that these substances are used in relatively few products and that these products have a relatively small turnover we have assumed that the number of companies supplying the ingredients would, for economic reasons, be fairly limited.� Since the CTPA had alerted members to the problem they did not take the matter further at that point.� Ms Kelly suggested it would be most helpful if the DH could identify, on a worldwide basis, the sources that would be of concern.[164]
162. On 23 April 1992 Mrs Whyte summarised the above comments in a minute to Mr Murray and Dr Wight.[165]� Dr Wight replied the next day[166]pointing out that feedback had not been received from all of the companies notified at the time. She stated� �We can only assume they heeded the advice. Non-member companies may still be unaware of previous advice, assuming that they make these type of products (which given the target market Ms Kelly describes may perhaps be unlikely).� Do we have any way of estimating the likelihood (through CTPA or DTI?) or the extent of non-membership?� She also noted,� �We now know that France and Switzerland�have some BSE cases. At the very least it would therefore be appropriate to update the 1990 advice we issued, including these countries as unacceptable for source material.� She also observed that the manufacturing country was not always the same as the source country of raw material.� Therefore the message should be conveyed that� ��these products should not contain SBO�s or other ruminant offal /placenta materials at all, as we do not know how the ruminant SE situation could develop globally.�
163. The CTPA�s May 1992 Newsletter provided as follows:[167]
�Use of Bovine and Ovine Materials in Cosmetic Products
We have received an enquiry from the Department of Health about the use of the above materials in cosmetic products.� In particular the following ingredients were specified.
1).�� Bovine� (cattle)-derived offals, or proteins derived from these offals, such as: brain, spinal cord, spleen, thymus, tonsils, intestines.� These are the specified offals covered by the Bovine Offal (Prohibition) Regulations 1989
2).�� Ovine (sheep)-derived offal and ovine placenta.�
164. Members using bovine offal were asked to contact the CTPA as soon as possible.[168]� In her statement to the BSE Inquiry Ms Kelly says that the newsletter request received no positive response.� Members were not using these materials and were sourcing tallow derivatives and to a minimal extent gelatin from suppliers who were following UK guidelines.[169]
165. On 1 July 1992 Mrs Whyte sent a minute to Dr Wight copied to Dr Fielder attaching a proposed letter to the CTPA for their comment and approval. The draft advised that the CTPA might think it prudent to advise its members that bovine materials generally should not be used in cosmetics, whether or not they were sourced from countries with reported cases of BSE.� In the covering minute Mrs Whyte noted that �we have to accept that this advice will be difficult for the CTPA to enforce, particularly as we do not know about the smaller manufacturers not covered by the Association.�[170]��
166. On 3 July 1992 Dr Wight responded by way of a hand-written note on Mrs Whyte�s original minute.� She indicated that her view was that they should recommend that ruminant tissues should not be used.� This was copied to Mr Murray and Dr Fielder.[171]
167. On 6 July 1992 Dr Fielder replied to Mrs Whyte (copied to Dr Wight and Dr Gott).[172]� He stated that the situation was a little more complicated due to the uncertainty about which countries could be designated as being BSE free. Action at EU level should be considered since the Cosmetics Directive covered this area.� He felt that action was warranted at European level because� ��the concern is very predominantly with companies from outside the UK, in particular France.�� However, he foresaw problems with a voluntary ban as there was potential for an EU challenge over barriers to trade ��unless we take our case to the EC Working Group on Cosmetics and argue for a ban throughout Europe.��� He suggested a meeting to discuss the issue involving the DTI�s Consumer Safety Division.
168. On 23 July 1992 Dr Wight minuted Dr Fielder (copied to Mr Murray and Mrs Whyte).� She set out some points that might be useful to discuss when they met:[173]
�2.�� Firstly, we on the SE side have a rather scanty knowledge of the cosmetics industry.� It would be helpful if you could provide any background information on the trade.
As part of this, what about current controls � regulations and otherwise � governing the use of raw materials, with respect to microbiological rather than chemical safety, and how is the safety of the production process and the end product monitored?
3.��� Is it possible to compare any trade controls with controls used in the drug industry?
4.��� How do our controls relate to EC requirements and how, if necessary, are these enforced?
5.��� Do you have any idea as to what sort of products are likely to be a problem with bovine/ruminant derived materials and is it possible to have details of the handling of these materials in the production process?� Would any of the likely compounds be for non-topical use?
6.��� We recognise that we are discussing theoretical rather than proven risks, which makes deciding on a course of action more difficult, particularly if any action would have repercussions in the EC.
While we feel there is a need to update the previous DH advice, we need to think how this might best be done, and how it can reach all parts of the trade effectively.�
169. On 3 August 1992 Mrs Whyte minuted Dr Wight and Mr Lowson, attaching a draft invitation to the CTPA to attend an informal meeting with DH and MAFF representatives. The minute said:[174]
�I should be grateful if you could let me know as soon as possible if you are happy with the draft so that we can arrange the meeting within the next week or so.�
170. On 10 August 1992 Mrs Whyte minuted Mr Ridgeway and said:[175]
�1. Please see my minute of 3 August to Dr Wight and Mr Lowson (MAFF) below. To date I have not received their reply and comments on the draft letter to the CTPA.
2. Could you please ring them and ask when they will be able to reply as we would like to arrange the proposed meeting with the CTPA as soon as possible.�
171. A handwritten note from Mr Ridgeway on 10 August 1992 replied to Mrs Whyte�s minute, stating that Mr Lowson had said, �the draft letter to the CTPA is fine; ok to go ahead and arrange the meeting; he would like MAFF to be represented, most likely by Ray Bradley.� Dr Wight�s comments are attached.�[176]
172. On 14 August 1992 Mrs Whyte sent a minute to Dr Fielder informing him that a meeting could not be arranged until early September because of the leave arrangements of the relevant parties. She also attached a draft letter to the CTPA that asked for an informal meeting to go through the latest developments on BSE. With the CTPA�s agreement a DH/MAFF team of experts would also be at the meeting to give advice on BSE.[177]
173. On 21 September 1992, a meeting was held between the DH (Drs Wight and Fielder), the DTI (Mrs Payne), MAFF (Mr Bradley and Mr Dixon) the CTPA (Ms Kelly) and other cosmetics industry representatives (Jane Shutt (Procter and Gamble); Vic Hyde (L�Oreal); Martin Adams (Unilever)).[178]� Dr Wight stated that the purpose of the meeting was� ��to reappraise the situation with respect to BSE and the use of bovine and other materials derived from animal origin in cosmetics manufacture.�� This is also Ms Kelly�s recollection in her statement to the Inquiry; she adds that the situation in the UK and worldwide had changed since the CTPA had last issued advice to its members in February 1990.[179]� Ms Payne has stated that her involvement in the area of BSE and cosmetics resulted from an invitation from the CTPA to attend this meeting.[180]
174. The draft minute of the meeting records the following:[181]
�MK and JS said that the cosmetics of concern can be divided into two � 10% expensive �exotica� which could contain the particular tissues of concern to DH such as cerebrocides, placenta (either human or other animal) and 90% are the routine products, many of which are based on collagen, elastin and gelatin.� �
MK explained that the French cosmetics industry was soon to hold discussions with their Department of Health and it was likely that the use of placental material, particularly human, would be discontinued in any cosmetics.� The main producers of �exotica� were French and American, the products very expensive and therefore the companies would have the resources to ensure the safety of their products by safe sourcing eg from Australasia where there is no scrapie and no BSE.� Small UK manufacturers would not be producing products containing animal materials but would rely on vegetable materials.� They were not thought to be likely to be incorporating materials of concern, and this was also true for those producers of �natural� products who would not necessarily be members of the CTPA.��
175. Mr Bradley indicated that tallow should be derived from the rendering of protein and fat waste from cattle only after SBOs were removed. However in general tallow was not felt to be a problem because of the tissues it was derived from and the extraction processes involved.[182]�
176. It was concluded, �Concrete advice may well not be feasible and guidance would probably need to centre around the industry knowing what questions to ask of their suppliers of source material.�� CVL offered to act as a contact point to help industry develop these questions and provide answers as far as possible. The CTPA indicated that they would consider the information provided at the meeting and then reach their own conclusions.� Ms Kelly leant towards the view that the most logical course might be to advise against the inclusion of any animal offal in cosmetic manufacture. The CTPA would issue advice to its members after consultation and agreement with the DH and MAFF.
177. While giving oral evidence to the BSE Inquiry, Dr Wight was asked whether the consultation and agreement referred to took place.� She responded:[183]
�To be honest I cannot recall it, no.� It was not clear from the bundle I got whether or not that had actually happened, although there clearly was some ongoing discussion after the meeting in 1992.� Quite what form it took in terms of the detail of the advice, I am afraid I cannot help.�
178. On 23 September 1992 Dr Wight minuted Mr Bradley, Dr Fielder, Mr Dixon, and Ms Payne, enclosing a draft note of the meeting.� She noted:[184]
�Incidentally, we did not talk about any input DTI might wish to make to the advice that will be issued.� Can Ms Payne and Dr Fielder clarify if this is necessary?�
179. In her supplementary statement to the Inquiry Ms Payne states:[185]
�3. Following receipt of Dr Wight�s draft note of the 21 September 1992 meeting between DOH, MAFF and DTI, I telephoned Dr Fielder to discuss the draft meeting note and to agree action to be taken in the light of that meeting.�
4. We recalled that the CTPA had mentioned that the French cosmetics industry would be discussing the use of bovine materials in cosmetics with their Ministry of Health and that this could lead to the industry producing Europe-wide guidelines, in consultation with COLIPA, the European cosmetics trade association.� We agreed that we should ensure that whatever the outcome of the meeting in France, UK industry should be issued with guidelines, the content of which would need to be agreed by experts in MAFF and DoH before being circulated to the industry.� Dr Fielder said he would let Dr Wight know what we had decided.
5. After speaking to Dr Fielder I rang Marion Kelly at the CTPA to check whether she had received any feedback from the French cosmetics industry and if any progress had been made in drafting the industry�s guidelines.� I was told that the French Ministry of Health had expressed concern to its industry over the use of bovine material in cosmetics.�
6. In view of this, the CTPA had agreed with their French counterparts that they should jointly draft guidelines for the use of both their industries.� They also agreed to discuss the provision of guidelines with other cosmetics trade associations in Europe.� Ms Kelly told me that COLIPA would be hosting a meeting to facilitate the latter and, in the meantime, she would be raising the issue of guidelines with the CTPA Council who were due to meet.� I was later informed by Ms Kelly that the CTPA Council had agreed that draft guidelines should be prepared for the UK industry and that these should be drafted jointly with the French industry, drawing-on advice from MAFF and DoH.
7. I recall relaying this information back to Dr Fielder.� We agreed that DoH would keep DTI informed of any developments regarding the content and issue of the industry guidelines. ��
180. Dr Fielder responded to Dr Wight�s note of 23 September on 29 September 1992.� He expressly left the question of DTI input for Ms Payne to comment.� The BSE Inquiry has been unable to trace any response from DTI.� Dr Fielder stated:[186]
�However the real concerns are with the bulk materials collagen, elastin and gelatin.� I would be grateful for a sight of the conclusions of the DH/MAFF expert group as soon as this is available.� I presume that we do not believe that there is any significant risk from products such as collagen and elastin (at least not sufficient to take immediate action): these materials are very widely used in skin creams and we should perhaps try to be somewhat more specific in this area when we comment on the CTPA proposals.� I am not really clear how serious are our concerns in this area.��
181. On 30 September 1992 Ms Kelly wrote to Dr Wight noting that the company promoting a range of products containing cerebrocides was now changing over to a synthetic alternative. In addition she was chasing the report from their French counterparts on their meeting with the French Department of Health.[187]
182. On 1 October 1992 Dr Wight again minuted Mr Bradley, Dr Fielder, Mr Dixon and Ms Payne.� She enclosed a final note of the meeting, and suggested that Mr Bradley, Dr Fielder and anyone else who was interested could get together to discuss the CTPA proposals for advice when they arrived.[188]
183. On 2 October 1992 Mrs Payne, with DH representatives, attended a meeting of the Cosmetic Products Working Party.[189]� An extract from the official record of this meeting notes:[190]
�Comment by the Italian delegation on the problem of contamination of animal extracts (from cattle, sheep, goats) by the BSE virus found in medicinal products based on these extracts: what was the situation as regards cosmetics?
The Italian delegation had sent a note to the Commission to ask for an assessment of the categories of cosmetic products that contained the substances (animal extracts � principally based on brain and marrow) so that they could be withdrawn from the market.
The delegation thought that cosmetic products applied to the mucous membranes or around the eyes were the most dangerous.
Action
The Italian delegation would provide the Commission with its entire documentation on this issue.�
184. On 7 October 1992 Mrs Whyte sent a minute to Dr Wight regarding the minutes of the 21 September meeting.� She informed Dr Wight that Mr Adrian Dixon said that either he or Mr Maslin would be interested in attending a meeting to discuss the CTPA�s proposals for advice to their members.�She also said, �I have asked Dr Fielder to keep us informed of the outcome of the French Industry�s discussions with their Health Ministry, but understand from him that this may take some time to come through.�[191]
185. On 7 October 1992 the CTPA Council received a report on the meeting with DH, the DTI and MAFF. It was noted that an equivalent meeting of their French counterparts had taken place on 23 September 1992. The CTPA said that they were going to liaise with the French Federation (the trade association representing the industry in France) on this issue to produce joint guidelines.[192]
186. On 8 October 1992 Mr R T Jones, Director of Research and Development at Croda Colloids, wrote to Ms Debra Redbourn, Scientific Officer at the CTPA, to offer some comments on the subject of BSE and proteins used in cosmetics.� He said that hydrolysed gelatin (collagen) represented the major source of cosmetic protein, and attached a statement he had prepared summarising the relevant information relating to any risk from BSE.� He continued:
�We believe that the nature of the raw material and the manufacturing process for gelatin ensures freedom from any risk to human health and this is the view of the BSE experts.� With regard to other bovine-derived cosmetic proteins, it is not possible to offer a general statement and each product may have to be considered on its own merits.� However, in general the treatments given to the raw materials are at least as severe as those used in gelatin manufacture and known to destroy BSE (e.g. NaOH for 1 hour at 25�C).
��
187. The paper attached to Mr Jones� letter considered the risk from BSE in relation to �[g]elatin and its hydrolysates for use in cosmetics�. It noted� that the European Federation of Pharmaceutical Industries Association placed gelatin in the category of materials unlikely to present any risk of contamination from BSE, and that the raw materials, i.e. bones and skins, were placed in the lowest risk category (no detectable infectivity) by both EFPIA and the WHO.� The paper continued:[193]
��
In the USA, the US Department of Agriculture (USDA) introduced regulations (Title 9, Parts 94 + 95 on Importation of Animal Products and By-Products from Countries where BSE exists) to prohibit or restrict import of animal derived products which pose a risk of introducing BSE into the USA. However, gelatin was specifically excluded from these restrictions provided it is intended for �use in human food, human pharmaceutical products, photography or some other use that will not result in the gelatin coming in contact with ruminants in the US.�
The USDA also states that �certain listed products may be imported into the United States for use as ingredients in cosmetics.� The products are collagen, collagen products ---- derived from ruminants that have been in any country where BSE exists.�
188. On 29 October 1992 Ms Kelly wrote to a member of the CTPA to explain that Italy had asked for the issue of bovine materials in cosmetics to be raised at the next EC Working Party on Cosmetics in Brussels. The Committee on Proprietary Medicinal Products guidelines [on medicinal products] were to be the focus of this discussion. The Italian trade association UNIPRO had offered to provide the Italian Government with a list of bovine ingredients used in cosmetics together with any advice issued on the avoidance of contamination.� Ms Kelly requested a copy of these from COLIPA, the European trade association.� She went on to say that the next COLIPA Technical Committee would consider the European pharmaceutical guidelines with respect to cosmetics.� Finally, she said she would be writing to DH informing them of recent developments and added that since products could move freely within the EC there did not seem to be any sense in having UK guidelines that were out of step with the rest of Europe.[194]
189. On 30 October 1992 Mr Phillipson wrote to Mrs Whyte.� He referred to the meeting of 21 September 1992 at the end of which the CTPA had agreed to draft some guidelines for members after discussion with sister associations and to submit them to DH for further consideration.� He stated that the subject of BSE and cosmetics was ��now the subject of discussion among our sister associations in the EEC and the matter will be discussed at a technical committee of our European association in Brussels in the middle of November.� Following this it is hoped that guidelines will be produced for use by European industry.�[195]
190. On 4 November 1992 Mr Murray minuted Dr Fielder attaching the CTPA�s correspondence of 30 October 1992.� Mr Murray commented that the guidance had to be accurate and not unduly single out the UK for restrictions.� He was also concerned that the exercise should not �drag on for an overlong period when guidance needs to go out as soon as possible.�� Mr Murray then asked:[196]
�Can I leave it to you to be proactive in tracking developments on the guidance, copying papers to me for information and comments as appropriate.� I will in turn ensure HEF(M) (Dr Wight) and MAFF colleagues are fully involved in any action we think necessary at Government level.�
191. On 17 November 1992 Dr Wight minuted Mr Murray (copied to Mrs Whyte) attaching a draft letter which she proposed to send to the CTPA. The draft letter stated that she was very happy to hear that the matter was being taken up at European level, and added �I trust this will not mean too great a delay is incurred in issuing guidelines and that the EC view will be consistent with our own�.� She also reported that SEAC had reaffirmed its view that tallow was not a high risk product, and that gelatin was also felt not to pose a risk.� However, she said that it remained advisable for the purchasing company to ensure SBOs were not used in the production process.[197]
192. On 18 November 1992 Dr Fielder minuted Mrs M McCarthy (HEF(A) 3A) regarding their telephone conversation of that morning.� He said that the latest letter he had from CTPA regarding bovine material in cosmetics was the one of 30 October 1992.� He stated� �I will be seeing Mr Phillipson at CTPA on Friday about another matter and will raise the issue of timing with him then�.[198]
193. On 4 December 1992 Dr Wight�s draft letter of 17 November 1992 was sent to Mr Phillipson.[199]�
194. Dr Fielder visited Mr Phillipson at the CTPA the following week to discuss the timing of the guidelines.[200]�
195. On 7 January 1993 Dr Fielder sent a note to Dr Wight confirming that the Italians would raise the issue of BSE and cosmetic products at the 22 January 1993 meeting of the EC Working Party on Cosmetics, which Dr Gott was to attend.[201]� He attached a copy of the Commission of the European Communities (CEC) proposals, which were �basically the CEC guidelines re medicinal products.�� Dr Fielder continued:
��
2.��� At a quick look the CEC proposals look reasonable in principle as a basic consideration of cosmetic products.� I understand that CTPA see no major problems with this.� Also that they have still not heard from the French regarding their Government/Industry proposals.� If he does not hear from the French next week, he will be happy to discuss a UK line that could be based on this CEC document.�
3.��� Do you believe that the CEC document can be supported?� We will be discussing this at a briefing meeting with DTI and CTPA on 21st January.
��
196. In her statement to the Inquiry Ms Kelly states that on 21 January 1993 the CTPA held a meeting at which DH and the DTI were present.� BSE was discussed, and it was noted that BSE was going to be raised by the Italians at the next Cosmetic Products Working Party meeting to be held the next day in Brussels.[202]� Ms Payne attended this meeting on behalf of DTI.[203]
197. The Cosmetic Products Working Party met on 22 January 1993.� Ms Payne and Dr Gott (Higher Scientific Officer for the Health Aspects of Environment and Food Division, responsible for Toxicology, Food Chemical Safety and Nutrition) attended.� In her statement to the BSE Inquiry, Ms Payne states �[a]cting on advice received from DH and MAFF, I informed the Working Party that there was no evidence of humans contracting BSE from cosmetics and that the BSE epidemic had been successfully contained in the UK.�[204]� The note of the meeting records the following:[205]
�The I[talian] proposal on use of bovine material in cosmetics was introduced.� UK welcomed the proposal which represented a sensible approach for those products using untreated material and that they understood that products such as tallow and collagen as currently produced would not pose a significant risk.� F[rance] noted that due to the considerable work on medicines (several of which were withdrawn) they had considered cosmetics and had a Higher Council of Public Hygiene opinion of January 14.� This recommended that bovine material be supplied from countries free of epidemic providing the following conditions were met: veterinary survey, consumption of meat flour was controlled, material was class IV or from animals under 6 months old.� It also limited ovine material to classes 1, 2 and 3 provided the processes deactivate it.�
198. On 4 February 1993 Dr Gott sent a note to Dr Wight (copied to Dr Fielder) about the outcome of the meeting of the Working Party on Cosmetics. Dr Gott reported that no decisions had been made, since most Member States wanted more time to consider the issues.� He stated, �most Member States were clearly unprepared for detailed discussion and there was much confusion.� Essentially only the French and ourselves had a grasp of the problem.�� The Commission was to submit the subject to the SCC.� The UK had offered to send any relevant available advice from SEAC to the Commission to aid their deliberations.[206]
199. Dr Gott said that Mme Drion of the Commission had subsequently contacted him asking for any recent information on:
(i.) Studies in progress on the infectivity of organs of BSE infected bovines
(ii.) The epidemiology of BSE
(iii.) The risk to humans of specific cosmetic ingredients of bovine origin
(iv.) Decisions on such materials in the UK
200. Dr Gott said the UK intended to restate support for the proposal already circulated and this line was supported by CTPA.
201. On 8 February 1993 Dr Wight replied to Dr Gott.[207]� She referred to the view of SEAC at its last meeting that tallow and gelatin posed a negligible risk of transmission of the agent.[208] In response to Dr Gott�s questions about recent information, Dr Wight enclosed a copy of the Tyrrell Report, which detailed ongoing research, and of the report MAFF had recently made to Parliament.� She stated that data on the risk to humans of specific cosmetic ingredients of bovine origin were limited and referred again to the deliberations of SEAC.� She suggested that probably the CSM guidelines remained the best guide.
202. On 12 February 1993 Dr Gott wrote to Mme Drion, telling her that he was �informed that the only legislation likely to be applicable to cosmetics manufacture would be the Specified Bovine Offal Prohibition Order.�[209]
203. By 17 March 1993 an English translation of the French proposals from their Higher Council of Public Hygiene had been obtained and Dr Fielder communicated this to Dr Wight in a minute of that date. He thought, as did the CTPA, that these proposals were satisfactory and should be supported in the May meeting of the EU Working Group on Cosmetics. The proposals noted that the risk of infection via beauty care products used on damaged skin was of the same order as the risk of infection through food.� In Dr Fielder�s view the majority of countries would go along with the proposals if both Britain and France supported them.[210]
204. CLARIFICATION:
205. In her statement to the BSE Inquiry, Ms Kelly states the CTPA prepared general guidelines for its members �around this time� (paragraph 23).� The BSE Inquiry has a copy of guidelines dated 22 March 1994 (YB 94/03.22/5.1). A CTPA file note indicates that guidelines were produced in March 1993, but a further file note indicates March 1994.� The CTPA believe that a first draft may have been produced in 1993 and final guidelines in March 1994.� The guidelines were made available to the membership in May 1994.
206. On 5 April 1993 Dr Wight commented on the French proposals in a minute to Dr Fielder.� She stated �some of my comments may, I think, arise because this is a rather poor translation.� Her comments were: [211]
�The statement in the 1st paragraph is not strictly true, if the human SE Kuru is taken as an example.� Oral transmission was not absolutely proven in the case of Kuru, though circumstantially both this route and the cutaneous route were implicated in transmission and maintenance of the epidemic.� Other work in animals (e.g. inoculation of SEs from various hosts, into rodents) supports the concept of a species barrier.
In the 3rd paragraph the oral route appears to be 5 times less efficient in transmitting mouse scrapie than the peripheral route, not 1-2 less as suggested here.�Therefore, it should not be accepted that the risk of infection via beauty products applied to damaged skin is necessarily the same as via ingestion in food.
�Sourcing from countries free of BSE� in the 4th paragraph, although theoretically desirable, is not as important a factor as ensuring correct controls and surveillance networks are in place in the countries of origin.� The recommendations in the final paragraph cover the sourcing aspects better and perhaps the recommendations on veterinary surveillance etc could be included here.�
207. On 20 April 1993 Mrs J Inglis (HEF(A)2D) minuted Mr A Dixon (MAFF) regarding the use of bovine material in cosmetics.� She said that as previously discussed, the use of bovine material in cosmetics had been taken up at European level.� She also said, �Dr Wight informs me that she has recently spoken to Mr Bradley on the subject and is content that the matter is developing satisfactorily.�[212]
208. On 22 June 1993 Mr J F Howard (Animal Health Division MAFF) contacted Dr Wight seeking an update regarding the EU position.� He referred to a discussion between Dr Wight, Mr Bradley and Mr Maslin on the progress of the proposed guidelines before the SEAC meeting in April, and stated that he understood that:[213]
��[You] undertook to establish the timetable for EC discussions and on that basis decided not to raise the matter at that meeting.� Mr Maslin made the point that the committee should be involved at some point and that this should be before any decision by the EC.�
209. Mr Howard asked whether discussions about the proposed guidelines were underway in Brussels. If they were, he wanted to know whether the issue should be raised at or before the next SEAC meeting.� Dr Wight asked Dr Fielder, by means of a handwritten note dated 23 June 1993 on this minute, whether he had any information of the progress of the discussions with the EC, or what the UK trade were doing.
210. Mr Bradley minuted Mr Howard on 23 June 1993 (copied to Mr Eddy and Dr Wight).� He said he had �had no direct contact with the EC regarding timetabling and have no knowledge that Dr Wight was formally asked to do this.�� He said he had spoken to Dr Wight with the following outcome:[214]
�1.�� She will send me a paper on the subject from Italy.
2.��� A previous translation of a paper from France was forwarded and suggested changes made.� This was copied to Mr Lowson on 26 March with a minute from me.
3.��� Overall Dr Wight does not see any serious problems.
4.��� The matter is being dealt with she told me by a technical sub-group of the Consumer Group in DGXI.� It is regarded as low priority and is moving very slowly.
��
6.� � Dr Wight will reply independently.�
211. On 5 July 1993 Dr Fielder wrote to Dr Wight to update her on the position reached on the EC discussions on the use of bovine material in cosmetics.� He agreed with the concerns Dr Wight had expressed in her 5 April 1993 letter but felt ��we could agree with the document in principle as could the CTPA.�� He identified the need for some changes but noted that the EC Working Party would not consider these until an opinion was obtained from the SCC (due to meet on 15 October 1993). The EC Working Party was not due to meet again until early 1994 and Dr Fielder said:[215]
�If agreement is reached at that meeting proposals will be included in a draft Commission Directive, adapting the Cosmetics Directive to technical progress which will be voted on in mid-1994. Such adaptions are only made on a yearly basis and if discussion is not concluded at the Working Group meeting in January/February 1994 the item may be deferred until the 1995 adaption directive.�
� �
7. As I have said earlier the EC pathway is relatively slow.� It is not because a particularly low priority is being put on this particular area (ie bovine material) as suggested in Mr Bradley�s minute of 23 June.� It is an inherent properly (sic) of the procedures used and the limited number of meetings available.� The advantage is that agreement are (sic) binding on all member states.�
8. If it is considered that the urgency of this area requires the UK to take unilateral action (I hope that is not the case) the way forward should I believe be to try and obtain some �voluntary� action under the auspices of the CTPA.� �� I do not believe we that we should (or need) to ask DTI to take unilateral regulatory action pre-empting the conclusions of the EC discussions in this area.� At present CTPA prefer to await the results of the EC discussions, but will be supporting (through the European Trade Association COLIPA) in principle the French proposals.�
9. We will need to arrange a meeting with CTPA if we believe the urgency of the situation requires unilateral action.�
212. On 6 July 1993 Dr Wight replied (copied to Mr Bradley, Mr Eddy, Mr Lister and Dr Fielder) to Mr Howard�s minute of 22 June 1993.� She said that the matter was progressing rather slowly at EC level because of the procedures necessary and the limited numbers of meetings available to the relevant Committee.�� Dr Wight indicated that the topic was likely to be discussed by the EC Working Party on Cosmetics at the beginning of 1994, and that following a favourable outcome of these discussions, adaptations would be made as necessary to the Cosmetics Directive and then adopted later in the year.� Dr Wight stated that she did not perceive any great urgency in the issue. There seemed to be in general agreement on measures to minimise risk with the CTPA, who in turn preferred to support European proposals rather than see any unilateral IK action at that stage.� Dr Wight asked whether recipients disagreed.[216]�
213. On 6 July 1993 Dr Wight also replied to Dr Fielder�s minute of the previous day.� She asked whether there had been any action on suggested changes to the French proposals and whether they were supported by the CTPA.[217]�
214. Dr Fielder acknowledged Dr Wight�s minute on 8 July 1993 noting that since the Commission had referred the question of bovine materials in cosmetics to the SCC there was no detailed discussion of the French proposals at the EC Working Group. This would occur in early 1994.[218]
215. On 24 November 1993 Mr Tim Hepburn (HEF(A) 2D) emailed Mr John Mullen (HEF(A) 2D) referring to a telephone call he had received from Stephanie Townsend at MAFF the previous day. He said that MAFF wanted to know about �an EC meeting on bovine eyeballs (sic) in cosmetics� due in 1994. He continued:[219]
�MAFF understand that there is going to be an EC conference next year to discuss the use of bovine material in cosmetics. MAFF wanted to know if DH have received papers yet and/or if we know who the UK reps at the meeting will be. MAFF will prepare some briefing for the meeting. Unless we in HEF(A) know (I don�t), can you have a word with Dr Wight to see if she has any info or can point us to someone who has.�
216. On the same day Mr Mullen sent a minute to Dr Wight (copied to Mrs Townsend) regarding the EC Conference on The Use of Bovine Material in Cosmetics: 1994.� He stated,� �Mrs Townsend (MAFF) has asked that should you receive papers for this conference to be held early in 1994, would you please arrange for copies to be sent to MAFF for Mr Bradley to prepare briefing.�[220]
217. On 2 December 1993 Dr Fielder minuted Dr Wight noting that the SCC would discuss the use of bovine material in cosmetics on 10 December 1993.[221]� He suggested deleting the exception clause for sourcing (�countries where only isolated cases have been recorded�).� He also attached a copy of the paper for consideration by the SCC. This was based on the report produced by the Belgian Senior Health Council which was in turn based on that produced by the French Health Council.
218. On 11 February 1994 the Working Group on Cosmetic Products held another meeting.� The minute of the meeting records the following:[222]
�8.2 Bovine spongiform encephalopathy (BSE)
- The DE delegation wanted measures to be taken as in the case of medicinal products, so as to ban the use of substances of bovine origin in cosmetic products.� The Commission would have to deliver an opinion on this subject in the case of cosmetic products.� The recommendation on medicaments could be taken as a guide.
- The Commission pointed out that the SCC was investigating the problem.
- The DE delegation asked whether the SCC was also examining the problem of contamination by other viruses and, if not, urged it to do so.�
219. On 30 March 1994 at a special meeting of the EC Health Council all Member States except Germany supported the UK and Commission view that existing measures to control BSE and protect public health were sufficient.� The German Health Minister issued a statement reserving Germany�s right to unilateral action.� Amongst Germany�s proposed restrictions was:[223]
�4.�� The issuing of recommendations to producers of cosmetics, based on the existing recommendations for the production of medicines.� Such a measure is necessary since the theoretical risk of BSE transmission by cosmetics is on a par with that in the case of medicines for external use.��
220. Mr Stelchen�s (EC Agriculture Commissioner) press release on 21 April 1994 said that �in order to supplement the guidelines for the manufacture of medicinal products, which had already been adopted, the Commission was developing guidelines for the manufacture of cosmetics�.[224]
221. On 24 May Mr Lister (HEF(A)10) sent a minute to Mr Baylis (PS/P(H)) in preparation for a meeting with Herr Wagner regarding BSE and the Germans.� A DH briefing attached to the minute stated:[225]
�The Commission already has guidelines which restrict the use of bovine tissues in medicines from countries with BSE, and is proposing similar guidelines for cosmetics. We support the extension of these rules. Germany has issued mandatory national requirements for medicines which go slightly further than the EU guidelines. They have also issued national guidelines on cosmetics. We are consulting with industry on whether the German national measures represent a barrier to trade for UK manufacturers.�
222. The CTPA�s May 1994 newsletter[226] noted that the CTPA had been reviewing the subject of BSE and cosmetics with both the DTI and the DH.� In her statement to the Inquiry Ms Kelly stated that the CTPA had stated in the newsletter that it understood that the German Health Ministry had issued separate draft guidelines for cosmetics which followed very closely those issued for pharmaceuticals. The basis of the guidelines was a scoring system where a minimum score had to be achieved before an ingredient could be acceptable for use in a cosmetic. They presumed that this would be forwarded to the EU Commission for consideration.[227]
223. On 23 June 1994 Miss Mulholland (Higher Scientific Officer for the Health Aspects of Environment and Food Division, responsible for Toxicology, Food Chemicals and Nutrition) wrote to Dr McGovern saying,� �The German proposals appear to be unworkable�.[228]� Professor Dony�s proposals, produced for discussion by the SCC, were favoured.� These mainly related to the guarantee of the cattle�s geographical origin and veterinary supervision.
224. On 15 July 1994, following reports that the French and Germans were calling for a European ban on British beef, Mrs Payne alerted Mr Walker that it was possible France and Germany might again question the safety of UK cosmetic products at the next Cosmetic Products Working Party (scheduled for 9 September 1994).[229]� Her minute states:[230]
�3.� Although there is no proof that �mad cow� disease can be transmitted to humans if, in the unlikely event, the French and Germans call for a ban on UK cosmetics the effect would be that soap manufacturers will need to source from UK herds which are certified �BSE-free� or import bovine extracts (see point 4).� The other alternative is to replace bovine extracts with other comparable ingredients, for example coconut oil.� Small firms which cannot adapt quickly and have low liquidity, will go under.� As for manufacturers of �exotica� products, they are virtually all based in France or Japan.
4.� If it is possible for humans to contract �mad cow� disease from cosmetics, the risk is greater from �exotica� products because, unlike soap ingredients, the ingredients are not subject to repeated boiling and some are just merely chilled.� MAFF have advised the CTPA that the only safe source is Australasia.� Along with other European countries, France and Germany have imported from the UK infected feedstuff and live cattle.� There have been reports of BSE outbreaks in Germany and France and even in the USA, a prime market for Jersey cattle.� The Germans claim that they have �cured� their infected cattle by bathing them in a special dip they have developed but MAFF say there is no magic German cure.� The French are masters at suppressing bad news.� However, their higher scientific committee has issued �approved BSE guidelines� for French industry to follow.� These guidelines cover, amongst other things, cosmetic products and are based on guidelines issued by MAFF.� The French have not credited MAFF at all and are touting their guidelines around the Commission.�
225. The EU Working Party on Cosmetics held another meeting on 9 September 1994.� The main purpose of this meeting was to discuss SCC reports on the safety of cosmetic ingredients.� Mr Walker, Dr Trott and Dr Mulholland attended.� Mr Walker�s note of the meeting dated 12 September 1994 records:[231]
�The Germans sought a Community approach on the issue of using animal derived ingredients from stock containing BSE.� The SCC chair Mr Kemper said SCC had had a look at the matter and said BSE-containing animal products were undesirable in cosmetics, but there was still a problem about data.�
226. The minute of the meeting records that �Professor Kemper said that BSE was being discussed, but it was now �a legal problem.��[232]
227. In October 1994 the German proposals on the control of animal products were submitted to the SCC.�
228. On 21 October 1994 the SCC issued an interim statement stating that ��since animal extracts may be contaminated with the causative agent of BSE, materials with the potential of transmitting such agents should not be used in cosmetics�.[233]�
229. On 25 November 1994 Miss Mulholland minuted Dr Wight (copied to Dr Fielder) and noted that the German proposals for control of animal products were �not very enthusiastically received as they were felt to be impractical and unwieldy�.� Miss Mulholland also said:[234]
�Nothing very much has happened since then.� At the last SCC meeting (October), as we understand it, a statement was made to the effect that materials derived from animals should not contain transmissible agents.� However, this does not seem to have translated into concrete proposals.� The discussion became rather confused with the issue of the use of human material (ie placenta) in cosmetics.� The French have recently introduced domestic legislation with this intention and the SCC (and member states) support this.� It is thought that proposals on both subjects will be forthcoming but it is unclear how long this might take.�
230. The Cosmetic Products Working Party met again on 16 February 1995.[235]� Ms Payne of DTI attended, along with DH.[236] The Commission informed delegates that the SCC had issued an interim opinion on 21 October 1994, which recommended against the use of animal materials where there might be a risk of transmission of BSE.� The Working Party concluded that there was no need to amend the Cosmetics Directive to ban the use of bovine material. It was influenced by COLIPA�s assurance that its members only used materials sourced:[237]
(i.) from BSE-free herds
(ii.) from animals less than 12 months old
(iii.) from body parts for which the World Health Organisation confirmed no risk of infectivity
(iv.) from bovine material subjected to heat or acid treatment to remove any possible risk.
231. Another factor was that the Working Party considered the opinion issued by the SCC too general to be used as a basis upon which to alter the Cosmetics Directive.[238]� The Working Party noted that the SCC was working on more detailed proposals and therefore no decision was made at this meeting.[239] The possibility of a future amendment was not completely ruled out.[240]
232. On 12 September 1995 Mr Bradley (CVL) replied to queries raised in relation to a �World in Action� programme.[241]� He stated�
�5.�� Surveillance is not regarded as necessary in respect of pharmaceutical and cosmetic products manufactured in the UK for use in the UK since the relevant trading organisations and individual pharmaceutical companies are acquainted with the relevant guidelines.�
233. Mr Bradley also minuted Mr P Hayward from the Press Office at Whitehall Place West on 22 September 1995 about the World in Action programme. He said:[242]
�The safety of cosmetics is controlled in the EU via the Cosmetics Directive 76/768/EEC which is updated annually. The UK has implemented this Directive via the Cosmetic Products Safety Regulations 1989. These state �A cosmetic product must not be liable to cause damage to human health when it is applied under normal conditions of use�.
The EC has been developing a set of guidelines for manufacturers via the Scientific Committee for Cosmetology. These have yet to be finalised.�
In regard to BSE, in the UK all the cattle reported as suspects and believed clinically to have BSE are compulsorily slaughtered and carcases are incinerated so no part can be used for any purpose. The specified bovine offals (SBO) from all other cattle over six of months age are also removed at source so they cannot be used for cosmetic production. In addition, intestine and thymus gland from cattle of any age are similarly proscribed. Recent legislation effectively makes the skulls (including the brain and eyes from cattle over 6 months) SBO since these organisms must not be removed��
234. On 22 March 1996 Dr Fielder sent a minute to Dr Wight to update her on the situation in relation to cosmetics and BSE. He� noted:
��
As you know this is an on-going area which has proved slow to progress at the regulatory level, since we are department (sic) on decisions being taken by the EC Working Party on Cosmetics (DTI lead and we provide support relating to the health effect of chemicals).� They in turn are dependent on receiving expert advice from the CEC�s Scientific Committee on Cosmetology (SCC) established under the terms of the Cosmetics Directive to advise on the safety issues.
�
At the end of 1994 the SCC issued a statement on this issue, namely �since animal extracts may be contaminated with the causative agent of BSE, materials with the potential of transmitting such agents should not be used in cosmetics.�[243]
235. In her statement to the BSE Inquiry, Ms Kelly said:
�31. Following the publication of Commission Decision 96/239/EC in March 1996, the CTPA immediately asked for details of bovine derived ingredients used. This survey confirmed that:
a)�������� Tallow derivatives were the only ingredients of overriding importance, these being widely used and not easily replaced by non‑animal derived materials. The usage of any other bovine derived ingredients was very limited.
b)�������� Major ingredient suppliers were already supplying materials of non‑UK‑bovine origin. In a telephone conversation with one supplier I was told that the German industry had, for some time, been requiring that ingredients supplied to them should be of non‑UK‑bovine origin. I do not have any documentation on this subject or further information.
�
33.�� By 1996 almost all members were able to certify that their bovine derived material was sourced from outside the UK. Those who could not obtain such certification were in the process of resourcing that material. Most of the UK industries had sourced material from two major suppliers who assured them that their tallow derivatives and gelatin met UK guidelines.
34.�� The 1996 survey revealed that the industry had been using pharmaceutical grade tallow derivatives and gelatin in their products. The cost implications of using such high grade tallow derivatives and gelatin are not significant to the industry. The tallow derivatives represent a tiny proportion of the overall cost of the product but have noticeable effects on the quality of the final product.�[244]
236. The Cosmetics Directive was subsequently amended by Commission Directive 97/1/EC on 10 January 1997 to prohibit the use in cosmetics of:
�Bovine, ovine and caprine tissues and fluids from the encephalon, the spinal cord and the eyes, and ingredients derived therefrom.�
237. The Cosmetics Directive was further amended by Commission Directive 98/16/EC on 5 March 1998 to prohibit the use in cosmetics of:
�(a) the skull, including the brain and eyes, tonsils and spinal cord of:
������ - bovine animals aged 12 months,
- ovine and caprine animals which are aged over 12 months or have a permanent incisor tooth erupted through the gum;
(b) the spleens of ovine and caprine animals and ingredients derived therefrom.
238. However, tallow derivatives may be used provided that the following methods have been used and strictly certified by the producer:
- Transesterification or Hydrolysis at at least: 200�C, 40 bars (40,000 hPa) for 20 minutes (glycerol and fatty acids and esters);
- Saponification with NaOH 12 M (glycerol and soap);
- Batch process: at 95�C for three hours, or
- Continuous process: at 140�C, two bars (2000 hPa) for eight minutes����� or equivalent conditions.�
[1] L18 Tab 29
[2] L9 Tab 7 p3
[3] DO01 Tab 6 p 2
[4] S Fielder para 18
[5] Article 3
[6] S Fielder para 18
[7] Footnote to Directive
[8] S Roscoe para 17; S Fielder para 18
[9] L9 Tab 6
[10] L 9 Tab 6 p7
[11] Consumer Protection Act 1987 s 19; L9 Tab 6 p17-18
[12] Consumer Protection Act 1987, s 10(3); L9 Tab 6 p7
[13] Consumer Protection Act 1987, s 10(7); L9 Tab 6 p 8
[14] Consumer Protection Act 1987 s 11;� L9 Tab 6 p8
[15] L9 Tab 6 p 8-9
[16] DO01 Tab 6a para 7
[17] L9 Tab 6 p 24
[18] DO01 Tab6 para 3
[19] Consumer Protection Act 1987 s 27(2); L9 Tab 6 p 24
[20] D0O1 Tab 6a para 6
[21] Consumer Protection Act 1987 s 14; L9 Tab 6 p12-13
[22] DO01 Tab 6a para 4
[23] Consumer Protection Act 1987 s 16; L9 Tab 6 p14-15
[24] DO01 Tab 6a para 8
[25] Consumer Protection Act 1987 s 28; L9 Tab 6 p25-26
[26] Consumer Protection Act 1987 s 29; L9 Tab 6 p26-27
[27] L9 Tab 6 p 11
[28] L9 Tab 6 p 16-17
[29] S Roscoe para 1
[30] S Roscoe para 22
[31] DO01 Tab 6a para 9
[32] S Roscoe para 6
[33] S Roscoe para 1 and para 5
[34] S Roscoe para 6
[35] S Roscoe para 7-8
[36] S Roscoe para 9
[37] S Roscoe para 11; S Payne para 2
[38] S Payne para 2; S Payne 2 para 2
[39] S Payne para 1
[40] S Pickles paras 2 and 11
[41] S Wight para 3-6, para 49
[42] S Fielder para 2-13
[43] S Singh para 5.
[44] S Fielder para 14.
[45] S T Murray 1 paras 5-11.
[46] S Murray para 10
[47] S Roscoe para 15-16
[48] S Roscoe para 18
[49] S Roscoe para 11
[50] S Roscoe para 16.
[51] S Kelly para 41
[52] S Kelly para 42
[53] DO01 Tab 6a para 23
[54] S Roscoe 2 para 4
[55] DO01 Tab 6 para 17
[56] S Kelly para 15
[57] DO01 Tab 6 para 16
[58] S Roscoe para 30
[59] IBD 1 Tab 2.
[60] IDB 1 Tab4 para A1d
[61] YB 89/6.20/9.1
[62] YB89/6.30/3.1
[63] YB89/7.14/1.1
[64] YB89/7.21/11.1-11.11
[65] YB90/1.5/3.1
[66] YB90/1.5/3.1
[67] YB90/1.5/3.3
[68] S Pickles 115D para 6
[69] S Roscoe paras 24 and 28
[70] S Roscoe para 31
[71] YB 90/01.26/18.1; note that the attached draft letter in the Inquiry�s yearbooks contains hand-written amendments which were not present on the draft when Dr Singh circulated it.
[72] YB 90/01.29/17.1
[73] YB 90/1.29/1.1
[74] YB 90/1.29/1.1
[75] YB90/1.29/15.1
[76] YB 90/1.31/14.1
[77] YB 90/2.1/4.1
[78] YB 90/2.1/7.1-7.4
[79] YB 90/02.01/14.1
[80] S Kelly para 3
[81] YB 90/02.02/13.1
[82] S Kelly para 5
[83] YB 90/02.08/10.1
[84] YB 90/03.00/6.1.
[85] S Roscoe paras 44-46
[86] S Roscoe para 51
[87] YB 90/4.6/4.1
[88] YB 90/4.11.1.1-1.6
[89] YB 90/4.12/1.1-1.4
[90] YB 90/4.23/1.1
[91] YB90/4.24/6.1
[92] In relation to this point se YB 90/1.29/1.1-1.2 and para 73 above
[93] YB 90/4.23/2.1
[94] YB 90/4.24/3.1-3.2
[95] YB 90/5.1/2.1-2.4
[96] YB 90/5.1/2.3
[97] YB90/5.3/11.1
[98] YB90/5.3/10.1-10.2
[99] YB90/5.9/1.1-1.2
[100] S Pickles 5 (WS 115D), para 9
[101] YB 90/4.24/7.1
[102] S Pickles 115D para 9
[103] YB90/5.22/27.1-27.6
[104] YB90/6.4/6.1-6.3
[105] YB90/6.7/21.1
[106] YB90/5.3/11.1
[107] YB90/6.11/3.1-3.3
[108] YB90/6.14/20.1
[109] YB 90/6.17/1.1-1.5
[110] YB90/6.22/6.1-6.46 at 6.41
[111] YB90/6.25/1.1
[112] YB 90/6.0/18.1
[113] YB 90/7.4/1.1-1.8
[114] YB 91/3.7/2.1-2.9
[115] S Pickles 1 para 62.3
[116] YB 91/3.7/3.1-3.2
[117] YB 91/03.25/9.1
[118] YB 91/04.23/4.1-4.2
[119] YB 91/04.24/7.1
[120] YB 91/04.26/4.1
[121] YB 91/04.29/1.1
[122] YB91/5.2/6.1
[123] YB 91/5.10/9.8
[124] YB91/5.13/3.1
[125] YB 91/5.22/1.1-1.3
[126] YB91/5.29/8.1
[127] YB91/6.3/3.1
[128] YB 91/6.17/6.1
[129] YB 91/6.19/6.1
[130] YB 91/6.19/6.1-6.2
[131] YB 91/6.25/7.1
[132] YB 91/06.26/3.1
[133] SEAC 9/2
[134] YB91/6.21/2.1
[135] YB 91/6.28/2.1-2.7
[136] YB 90/06.00/5.1
[137] YB 91/6.28/2.1-2.7
[138] YB 91/6.00/5.1
[139] YB 91/06.30/1.1
[140] YB91/7.3/3.1-3.2
[141] YB 91/7.24/3.1
[142] YB 91/7.25/3.1
[143] YB 91/7.25/3.1
[144] YB 91/8.00/3.1-3.6
[145] YB 91/8.5/1.1
[146] S Roscoe para 54
[147] SEAC10A/13
[148] YB 91/08.21/1.1-1.15.
[149] YB 91/9.6/2.1.
[150] YB 91/10.15/2.1
[151] YB 91/10.31/9.1
[152] YB� 91/11.06/6.1
[153] YB 91/11.06/6.1
[154] YB 91/11.13/2.1
[155] YB 91/11.25/2.1
[156] YB 91/12.09/3.1
[157] YB 91/12.19/2.1
[158] YB 92/1.28/2.1
[159] YB 92/01.00/9.3
[160] YB92/2.28/6.1
[161]� YB 92/04.01/5.1-5.4
[162] YB 92/4.02/4.1
[163] YB 92/4.14/2.1
[164] YB 92/4.14/2.1-2.2
[165] YB 92/4.23/2.1
[166] YB92/4.24/1.1-1.2
[167] YB 92/05.00/3.1
[168] YB92/5.00/3.2
[169] S Kelly para 7
[170] YB 92/7.01/6.1-6.3
[171]� YB 92/07.01/9.1
[172] YB 92/7.06/9.1-9.2
[173] YB 92/07.23/2.1
[174] YB 92/08.03/2.1-2.2
[175] YB 92/08.10/3.1
[176] YB 92/08.10/3.1
[177] YB 92/8.14/1.1-1.2
[178] YB 92/9.23/1.1-1.4
[179] S Kelly para 8.
[180] S Payne 3
[181] YB 92/9.23/1.3-1.4
[182] YB92/10.1/2.2
[183] T 71 Wight p105
[184] YB 92/09.23/1.1-1.4
[185] S Payne 2 paras 3-7
[186] YB 92/09.29/2.1
[187] YB 92/9.30/3.1
[188] YB 92/10.01/2.1-2.3
[189] S Payne para 4
[190] YB 92/10.02/4.2
[191] YB 92/10.07/1.1
[192] S Kelly para 16
[193] YB 92/10.08/2.1-2.3
[194] S Kelly para 17
[195] YB 92/11.4/3.2
[196] YB 92/11.4/3.1
[197] YB 92/11.17/6.1
[198] YB 92/11.18/2.1-2.8
[199] YB 92/12.4/1.1
[200] S Kelly para 21
[201] YB 93/1.07/3.1-3.2
[202] S Kelly para 22
[203] S Payne para 5
[204] S Payne para 6
[205] YB 93/02.04/1.3
[206] YB 93/2.04/1.1-1.3
[207] YB 93/2.08/3.1
[208] YB 92/10.15/2.6-2.7
[209] YB93/2.12/3.1
[210] YB 93/3.17/3.1
[211] YB 93/4.05/3.1
[212] YB 93/04.20/2.1
[213] YB 93/6.22/5.1
[214] YB93/6.23/1.1
[215] YB 93/7.05/2.1-2.2
[216] YB 93/7.06/2.1
[217] YB 93/7.06/3.1
[218] YB 93/7.08/3.1
[219] YB 93/11.24/1.1
[220] YB 93/11.24/2.1
[221] YB 93/12.02/1.1-1.5
[222] YB 94/02.11/6.1-6.2
[223] YB 94/5.24/9.1-9.6
[224] YB94/4.21/4.1
[225] YB 94/5.24/9.5
[226] YB 94/05.00/6.1
[227] S Kelly para 28
[228] YB 94/6.23/7.1
[229] S Payne para 7
[230] YB 94/07.15/16.1
[231] YB 94/09.12/3.1-3.3
[232] YB 94/09.09/7.1-7.2
[233] YB96/3.22/14.1-14.2
[234] YB 94/11.25/1.1
[235] YB95/2.16/6.1-6.2
[236] S Payne para 8.
[237] DO01 Tab 6 para 9
[238] DO01 Tab 6 para 10
[239] YB 96/3.22/14.1-14.2
[240] S Payne 8
[241] YB 95/9.13/1.2-1.3
[242] YB 95/09.22/7.1
[243] YB 96/03.22/12.1
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