April 30, 2003

Judgement Day

Soap, Perfumery & Cosmetics
The 7th Amendment has now come into effect. But what exactly does it mean for the industry? Elizabeth Driver highlights the provisions and explains what effect they're going to have on companies and on international trade The 7th Amendment to the Cosmetics Directive 76/768/EEC came into effect when it was published in the Official Journal on March 11, 2003. Member States now have 18 months to implement it, i.e. until September 11, 2004. Its provisions are likely to have far reaching consequences for the global cosmetics industry, particularly with respect to trade between the US and EC countries.

Provisions of the Amendment
  • Prohibition on animal testing or marketing of products tested on animals for:

1. testing of finished products from date of implementation of the Directive by Member States and marketing of finished products once an alternative is available

2. ingredients 6 years from the date of entry into force of the Directive, i.e. March 2009 except

3. where there are no alternative tests yet under consideration (repeated-dose toxicity, reproductive toxicity and toxicokinetics) deadline is 10 years from entry into force of the Directive, i.e. 2013. Any extension of the 2013 deadline requires co-decision of Council and Parliament.

  • Commission to set deadlines within the 6 year period for prohibition of animal tests as alternatives become available. Timetable to be available to the public by 11 September 2004.
  • Commission to establish timetable of deadlines for prohibition of marketing of cosmetics, the final formulation, ingredients or combinations of ingredients of which have been tested on animals.
  • Alternative methods of testing shall be developed, validated and adopted at Community level "with due regard to the development of validation within the OECD".
  • Alternative methods do not have to be applicable to all uses of chemical ingredients (as in the past); they may only be relevant to the cosmetics industry.
    • Methods validated by ECVAM [1] and approved by the SCCNFP [2] (Scientific Committee for Cosmetic Products and Non-Food Products) as applicable to cosmetics products will be published by the Commission.
  • Derogation from the testing ban may be permitted by the Commission after consultation with SCCNFP in exceptional circumstances where serious concerns arise over the safety of an existing cosmetic ingredient which cannot be replaced.
  • Producers will be able to claim that no animal testing was carried out in relation to the development of a product. Commission to develop guidelines to ensure that common criteria are applied in making such claims.
  • Following the opinion of the SCCNFP, substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under Directive 67/548/EEC on dangerous substances in category 1 or 2 must not be intentionally added to cosmetic products. Those in category 3 must not be intentionally added to cosmetic products unless it can be demonstrated that their levels do not pose a threat to the health of the consumer (requires evaluation by SCCNFP). This provision will take effect as soon as the Directive is implemented by Member States.
  • Cosmetic products must bear more precise indications concerning their durability for use including, for products with a minimum durability of more than 30 months, an indication of the period of time after opening for which the product can be used without any harm to the consumer. The Commission must establish a symbol to indicate durability after opening (an open cream jar) by 11 September 2003 and Member States must ensure compliance from March 2005.
  • 26 fragrance ingredients identified by SCCNFP as likely to cause contact allergic reactions must now be mentioned in the list of ingredients. They are added to Annex III, Part 1. Again, there must be compliance from March 2005.
  • The qualitative composition of the product, data on any animal testing performed by the manufacturer, his agents or suppliers and information on safety evaluation and any undesirable effects on human health must be easily accessible to the public, as soon as the Directive is implemented.

History of the 7th Amendment

The 7th Amendment represents the culmination of three years of sometimes heated debate between the Commission and the European Parliament. The provisions relating to animal testing originated in the 6th Amendment of June 1993, which provided for animal testing to be eliminated within 5 years but allowed for the possibility of extending the deadline to take account of scientific development of alternative tests. (The deadline was extended to June 2000). These provisions were introduced at the last minute at the request of the European Parliament and, perhaps predictably, proved impracticable. It was rapidly recognised that the development and validation of alternative methods presented a major scientific challenge but that repeatedly extending the deadline was not a politically or socially acceptable approach. The 6th Amendment imposed a marketing ban which the Commission believed was not tenable in the light of WTO rules.

The Commission's initial proposal in April 2000 was to postpone the marketing ban, which would have come into force in June 2000, at least while the 7th Amendment was drawn up and implemented. Their focus was an EU ban on testing, which was to be fully enforceable within 3 years, with provision for postponement for a further 2 years only, irrespective of whether alternative tests had been validated. International acceptance of alternative tests was not required, although the Commission was to make efforts to secure acceptance by the OECD.

The Committee responsible wanted to preserve the marketing ban which was supposed to have come into effect under the 6th Amendment. The Committee called for the marketing ban to come into force immediately for ingredients where other validated methods already existed and in any case 5 years after the adoption of the new Directive. There should be no discrimination between EC and non-EC countries to ensure compliance with WTO. The Committee also introduced new provisions on fragrance allergens and durability.

At the first reading in the European Parliament in April 2001, MEPs voted in favour of the Committee's proposals and also asked for manufacturers who had carried out animal tests after the date of implementation to label the packaging "Tested on Animals", the lettering to cover at least 20% of the total surface area of the pack.

The Commission amended its proposal following the first reading. They agreed to the proposals of the Committee and Parliament in respect of the matters other than animal testing, but were concerned about the marketing ban being in breach of the EU's obligations to the WTO. They therefore rejected the marketing ban and also the labelling proposal "Tested on Animals" and noted that any claims that some cosmetics are free of animal testing could be misleading: tests have been performed on almost every ingredient by someone at some time.

In February 2002, the Council drew up a common position, which was adopted with a qualified majority. The Council accepted the general principles expressed by the European Parliament on animal testing but proposed a step-wise approach to the ban with progressive implementation as alternative tests, including those which reduce the number of animals used, became available. The marketing ban would be linked to the implementation of the testing ban so that neither would come into force before alternatives were available. These would need to have been accepted at international level within the framework of the OECD. This common position gained the support of the Commission.

The common position then went back to Committee responsible who proposed further changes. In respect of the marketing ban, the Committee repeated Parliament's earlier call for a date to be set, which would be no later than 5 years after the adoption of the 7th Amendment. In the meantime, new cosmetic products tested on animals should not be sold where other validated tests existed. Again, they called for labelling "Tested on Animals". On the testing ban, the Committee set a final date of 31 December 2004, after which Member States should ban the testing of ingredients on animals in their territory. There was provision for testing only if scientifically justified to investigate safety concerns about an existing ingredient. Further proposals strengthened the provisions on durability, public access to data and CMR.

At the second reading, the European Parliament adopted the proposals of the Committee responsible.

The Commission then approved a number of provisions, but rejected the EU testing ban for ingredients, the fixed timetable of 5 years, the reintroduction of the marketing ban and the requirement of labelling "Tested on Animals".

Thus in the summer of 2002, the Commission and the European Parliament were still poles apart in their proposals on animal testing. It was only in December 2002 that the Conciliation Committee reached agreement on a joint text for the 7th Amendment, the main points of which are set out above. After a 12-hour debate, the European Parliament approved the joint text of the Conciliation Committee on 15 January 2003.

Throughout, argument had focused almost exclusively on the provisions for elimination of animal testing; the provisions relating to labelling, provision of information to the public, fragrance ingredients and CMR were incorporated with relatively little discussion.

Cost to the industry

By far the greatest cost to the industry will be the development of alternatives to animal testing. It has been clear for many years that this issue would have to be addressed, so the 7th Amendment merely accelerates the expenditure. Indeed, it could be argued that the 7th Amendment does nothing more than set a deadline on what is required under Directive 86/609/EEC on the protection of animals, which requires that animal experiments be replaced by alternative methods, when such methods exist and are scientifically satisfactory.

The development of alternative tests is not straightforward, either scientifically or politically. Under the terms of Directive 86/609/EEC, alternative tests must be "scientifically satisfactory" and provide "the same level of information as that obtained in experiments using animals." In order to ensure the validity of alternative methods, reliable in vivo data are essential and very often this is lacking or not publicly available. ECVAM are therefore faced with a major problem in validating a new test. Politically, alternative tests are a minefield. Will it be acceptable to the animal rights groups that some of the tests merely use fewer animals?

The question of who funds the research needed to develop alternative tests arises. Some finance may be available under the Sixth Framework Programme, but it is the industry's responsibility to develop alternative tests. One major problem is that much of the burden is likely to fall on the large companies who have the skills and resources to develop alternative test methods and they are likely to be reluctant to sacrifice commercial advantage by making the methods publicly available. If alternative methods cannot be found, it may prove necessary to substitute ingredients. A great fear is that innovation will be discouraged, which would be disastrous for the industry.

The cost of labelling changes cannot be ignored, particularly as there is the additional complication that the requirements in the EC are increasingly different from those in the US, making it difficult for companies to use the same labelling globally.

A recent analysis of the cost of implementing the 7th Amendment carried out by Dr Jan Vernon of RPA has put the total cost at something between 0.5 and 1.5% of the EU turnover of the cosmetics industry.

International implications

The ban on marketing of products tested on animals was recognised by the Commission as likely to provoke problems with the WTO, as it effectively means that any product developed for the US OTC market (antiperspirants, fluoride toothpastes, dandruff shampoos, suncare products etc), which are tested on animals in order to meet the FDA's safety requirements, could not be imported into the EC. Conversely, products developed and tested in the EC using the new alternative test methods may well prove unacceptable to the FDA, preventing sale of EC products in the US. Although the Commission have been at pains to ensure that there is no breach of the obligations to the WTO, unless alternative tests can be developed which are deemed acceptable by both the EC and the US, there will be an effective barrier to trade, in both directions. Currently, only alternative methods which are scientifically validated by ECVAM or by OECD and applicable to the whole chemicals sector are adopted at Community level but the 7th Amendment, in an effort to accelerate the use of alternative tests for cosmetics, now proposes the use of methods which are only applicable to cosmetics. It is questionable whether such tests would be acceptable by the OECD. These problems will be discussed further in a subsequent issue of SPC. The European Centre for Validation of Alternative Methods Scientific Committee for Cosmetic Products and Non-Food Products

[1] The European Centre for Validation of Alternative Methods

[2] Scientific Committee for Cosmetic Products and Non-Food Products
Subscribe Link

Email Disclaimer