My colleague Julie Girling MEP, who has been leading for Conservatives in the European Parliament on this important issue said:
“Thank you for your email concerning the use of animal testing testing on chemicals used in cosmetics for which there is a possibility of workforce exposure during manufacturing processes. This issue was brought to my attention last year and I have been in regular contact with the Commission and ECHA ever since.
Following pressure from MEPs and the public the Commission also set up a dedicated page on this issue:
At the time I submitted a written question to the Environment Commissioner Karmenu Vella, which can be found alongside the reply from the Commissioner at: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//TEXT+WQ+P-2015-000498+0+DOC+XML+V0//EN&language=en.
Based on these text, and my own personal conversations with the Commission and ECHA, it appears that the issue is rather complex, and ultimately legal in nature.
One of the principal objectives of the Cosmetics Regulation is that cosmetic products placed on the market are safe for human health when used under normal conditions. In order to comply with these objectives, manufacturers are required to conduct studies and provide safety data which prove the safety of their products for their intended uses.
It is prohibited, under the Cosmetics Regulation, from obtaining such safety data through animal testing of finished cosmetic products or their ingredients. Any product which has undergone such testing will be prohibited from being marketed – this is outlined in Article 18 of the Regulation (http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32009R1223&from=EN). Products intended for the market must prove that they are safe to be used with data obtained from validated alternative (non-animal) tests.
However, from a legal perspective, the issue of worker exposure during manufacturing is not covered by the ban in Article 18 of the Regulation. This is because the ban only covers testing necessary to meet the objectives of the Regulation i.e. consumer safety of finished products. Ensuring worker safety during the manufacture of cosmetic products cannot be defined as an objective of the Cosmetics Regulation (it is not mentioned at any point in the text) and thus the animal testing ban included in the Regulation cannot be extended to cover worker safety.
Of course, worker safety still needs to be ensured by other means, and is covered by the EU’s overarching framework for chemicals legislation: REACH (the Regulation covering Registration, Evaluation and Authorisation of Chemicals). REACH is the framework which aims to ensure a high level of protection of human health and the environment from the risks that can be posed by chemicals. It establishes procedures for collecting and assessing information on the properties and hazards of substances destined for the European market. Companies intending to market substances are required to register them centrally with the ECHA which evaluates the registration dossier for compliance.
When registering substances, companies are required to list the different intended uses of that particular substance and provide information on its safety for those uses. Because of the legal issue explained above, a substance’s use in finished cosmetic products would be one use, and its use in the manufacture of cosmetic products would be considered another, distinct use. ECHA would need safety data for both uses in order for the substance to be authorised.
Both the Commission and ECHA anticipate that in some cases certain alternative in vitro (i.e. non-animal) tests used to prove consumer safety may be sufficient to also prove worker safety, and no additional testing would be required. However, in many cases worker exposure to substances may differ to that of consumers in terms of concentrations and frequencies, and ECHA may require additional safety data to prove that the substance is safe for workers. In such an event, as a last resort, and where no suitable alternative test exists, ECHA may require evidence from animal testing. Since substances are assessed under REACH on a case-by-case basis, it is impossible to predict if, and how much, additional safety data may be required, and how much of this will be obtained from animal tests.
It must be noted, however, that a general principle applied across all EU legislation is that animal testing is only permitted where it is necessary to ensure public health, and then only as a very last resort. REACH is applied with a firm commitment to the “3 Rs” (Replacement, Reduction and Refinement) of animal testing and promotes the development of alternative methods. Within the legislative text of REACH there is an explicit reference that safety data should be derived from animal tests ‘only as a last resort’ and there is a mechanism for the annexes of REACH (which outline validated testing methods) to be regularly updated with approved alternative test methods. This is extremely important as where an EU-validated alternative exists, animal testing is not permitted.
I am reassured to see many such non-animal tests being approved. Only very recently, non-animal tests for skin sensitivity and skin allergies were approved and added to the REACH annexes, and are expected to be applicable from September 2016. This is a huge step forward as skin sensitivity is a key area from a worker safety perspective. For more information on these developments please see:
Furthermore, ECHA and the Commission are committed to ensuring the continued development of such alternatives, and their timely uptake by companies. In ECHA’s “Roadmap towards 2018″ it is stated that they are currently developing a guide including tips and recommendations for REACH applicant companies, specifically on the use of alternatives. In addition, they are updating and consolidating 5 existing practical guides into one, focusing on the principle of “animal testing is a last resort”. For more information please see:
http://echa.europa.eu/documents/10162/13552/reach_roadmap_2018_web_final_en.pdf and http://echa.europa.eu/en/reach-2018
Despite these positive steps, I still share your concerns that the intended objectives of the |Cosmetics Regulation – namely a total ban – are still not fully being realised. However, I am also confident that, due to substantial political and scientific momentum and commitment, we are moving closer each day. For my part I will continue following developments and maintain regular dialogue with the Commission and ECHA to ensure that this momentum is not lost.”