Does REACH hold a 'Catch-22' for cosmetics?

C&I Issue 9, 2009

Although burdensome, expensive andresulting in a reduction in the availabilityof many existing chemicals, industry has welcomed REACH as providing a transparent,dispassionate and objective evaluation of chemicals based on facts and figures.However, cosmetic products are also regulated by their own legislation, the EU’s Cosmetics Directive (76/768/EEC), which includes bans on testing cosmetic productsor their ingredients on animals, as well as marketing products tested on animals.

The cosmetics industry is being challenged to explain the apparent contradiction between, on the one hand,REACH requiring animal test data for newand existing chemicals and, on the otherhand, the Cosmetics Directive banning animal testing. Some groups have accuse idindustry of wanting to use REACH as a ‘backdoor’ to continue animal testing.

The facts, of course, are very different,but the responsibility for interpreting any apparent contradictions between these pieces of legislation lies first and foremost with the European Commission (EC) andultimately the courts. This view was madepublic by the EC in response to a written question from Daniel Caspary MEP on 25 February 2009.

In my view, there is no overlap and no contradiction – no ‘Catch-22’. The bans introduced by the Cosmetics Directive are absolute and cannot be changed or overturned by REACH in any way, shape or form. Similarly, the Cosmetics Directive cannot overturn any REACH requirements. They are two distinct and separatelegislative instruments.

Importantly, successful animal test replacements, already delivered by the cosmetics industry, are benefiting all sectors that are required to use them in place of animal studies.

The bans in the Directive refer specifically to testing on animals ‘for the purposes of this [theCosmetics] Directive’ and, although the final interpretation would be for the courts to decide,some examples would show the consequences of disregarding this phrase which, I believe, was included for a purpose.

Water is routinely tested on animals to ensure compliance with pharmaceutical legislation as‘water for injection’. Does this mean that the cosmetics industry should be denied water as an ingredient? If that were so, most cosmetics would disappear from the shelves and such an interpretation would, I think, be held up to ridicule. Water may be an important cosmetic ingredient but industry cannot prevent other sectors complying with their legal obligations. 

Another example relates to the actions of the Chinese government, which often tests cosmetic products exported from Europe on animals before allowing the products on to the Chinese market.The manufacturer does not request such testing,and indeed does not need the data to be sure ofthe product’s safety, as it already complies withthe Cosmetics Directive. Should testing by a foreign government for its own laws mean that product is disallowed in Europe? I don’t think so.

So, if we accept the principle that chemical testing on animals by someone other than the cosmetic manufacturer for quite separate legislation – whether European or not – should not invoke the bans of the Cosmetics Directive,that principle must equally apply to REACH;there is nothing fundamentally different here. If a chemicals manufacturer, supplier or distributor tests a chemical on animals to comply with their REACH obligations, that can have no bearing on the use ofthat chemical in a cosmetic product in Europe.

But does this mean that the bans in the Cosmetics Directive have no teeth? Again, I don’t think so. There are at least two areas that the bans will impact until suitable alternatives are available.

The first is where a cosmetic company is developing a new product, perhaps using a new ingredient, and requires additional data for safety reasons. The option to fill data gaps using animalsis forbidden, so this product could not be marketedin the EU.

The second area concerns the preparation ofsafety support dossiers to add new preservatives,UV filters or colours to the approved lists. The Scientific Committee on Consumer Safety (SCCS),which advises the EC, has said the dossiers require data that can only be obtained using animaltesting, meaning that there will be no opportunity to innovate in these areas in the EU.

So, the animal testing bans in the Cosmetics Directive do have teeth. Unfortunately, the consequences may be less innovation in Europe,currently the world’s leading cosmetics market. These bans are not compromised by REACH and REACH does not represent a ‘back door’ route to animal testing. REACH is a response to the public’s call forgreater certainty regarding chemicals; the fact that REACH may increase animal testing of chemicals is not the responsibility of the cosmetics industry and this industry will not be drawn into that debate.

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