Annexes to COM(2016)599 - Development, validation and legal acceptance of methods alternative to animal testing in the field of cosmetics (2013-2015)

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dossier COM(2016)599 - Development, validation and legal acceptance of methods alternative to animal testing in the field of cosmetics (2013-2015).
document COM(2016)599 EN
date September 19, 2016
Annex VII of Directive 2010/63/EU, including the validation of alternative test methods at EU level and the promotion of their regulatory acceptance.

During the period covered by the 2015 EURL ECVAM Status Report (May 2014 to September 2015), EURL ECVAM evaluated thirty test submissions 23 and successfully carried out several validation studies. In addition, the EURL ECVAM Scientific Advisory Committee peer reviewed validation studies and issued opinions on test methods in the fields of skin sensitisation, eye and skin irritation and toxicokinetics.

EURL ECVAM published a recommendation on a successfully validated skin sensitisation test and produced a report for the OECD on the development of a test guideline on this method. 24 Two additional recommendations are currently being prepared.

More details on these activities can be found in the 2015 EURL ECVAM Status Report.

Set-up of the EU-NETVAL

In 2013, EURL ECVAM set up the EU-NETVAL, 25 the European Union Network of Laboratories for the Validation of Alternative Methods, based on Article 47(2) of Directive 2010/63/EU. EU-NETVAL’s mission is to provide support primarily for EURL ECVAM validation studies. Following the 2015 call for membership, the network comprises more than thirty-five test facilities.

4.1.2.2.Regulatory uptake

Commission Regulation (EC) 440/2008 26 , which brings together all regulatory accepted testing methods at EU level, 27 has been updated three times since 2013. Another update is underway.

The in vivo tests for skin irritation/corrosion, serious eye damage/eye irritation and skin sensitisation required under the REACH Regulation did not adequately reflect the state of science any more. Therefore, in late 2014 the Commission proposed to amend Annex VIII to the REACH Regulation to fully replace in vivo with in vitro testing for these endpoints for substances in the applicability domain of the available in vitro tests. The annex amendment concerning skin irritation/corrosion and serious eye damage/eye irritation was adopted on 31 May 2016 28 . The Commission proposal on skin sensitisation received a favourable vote of the REACH Committee in April 2016.

4.1.2.3.The European Partnership for Alternative Approaches to Animal Testing

The Commission and industry representatives together facilitate the regulatory acceptance of alternative methods and approaches under the European Partnership for Alternative Approaches to Animal Testing (EPAA). They do so by running projects, and organising and financially supporting workshops and conferences. 29

4.1.3.Alternative methods for assessing the safety of cosmetic ingredients

The Scientific Committee on Consumer Safety (SCCS), in charge of evaluating the safety of cosmetic ingredients, recently published the 9th revision of its Notes of Guidance, with a special focus on the latest developments in the field of alternative methods and their suitability for each endpoint of the safety assessment. 30

4.1.4.Other activities in the area of alternatives to animal testing

The topic of alternatives to animal testing, and more generally of animal welfare, has recently received considerable attention in the EU. 1.17 million citizens signed the 2015 Citizens’ Initiative ‘Stop Vivisection’ 31 which requested to end all animal experimentation. In reply to this initiative, in its Communication of 3 June 2015 32 the Commission committed to several actions to accelerate the development and uptake of non-animal approaches in research and testing. One of these is to organise, by the end of 2016, a conference 33 engaging the scientific community and relevant stakeholders in a debate on how to exploit the advances in science for the development of scientifically valid non-animal approaches and advance towards the goal of phasing out animal testing without compromising human safety.

4.2.Progress at international level

4.2.1. Activities at OECD level

The methods for which OECD test guidelines are adopted are legally implemented at EU level through Commission Regulation (EC) 440/2008. 34 In addition, OECD-accepted methods are also suitable for regulatory use in the EU prior to their official inclusion in the Commission Regulation (EC) 440/2008.

In 2015, the Working Group of National Coordinators of the OECD test guideline programme (TGP) approved six new test guidelines, of which four were based on in vitro methods (on serious eye damage/eye irritation and endocrine disruption). In addition, ten existing test guidelines were updated.

A summary of the status of the adoption in the OECD TGP (2012-2015) of test guidelines based on alternative methods can be found in Annex I to the 2015 EURL ECVAM Status Report.

The Commission, through EURL ECVAM, plays an active role at OECD level. Within the OECD TGP, EURL ECVAM leads or co-leads ten projects on the development of new test guidelines or guidance documents.

Moreover, within the OECD Task Force on Hazard Assessment, EURL ECVAM leads projects related to the integrated approach to testing and assessment (IATA) which has become a priority over recent years as an alternative solution to animal testing. EURL ECVAM also co-chairs a group with the US Environmental Protection Agency. 35  

4.2.2.Other cooperation with third countries

At international level, the Commission is involved in various cooperation projects, notably through EURL ECVAM. These include the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, the World Health Organisation International Programme on Chemical Safety and the International Cooperation on Alternative Test Methods (ICATM) 36 set up in 2009 by the International Cooperation on Cosmetics Regulation (ICCR). 37

ICATM members agreed to strengthen their cooperation on conducting validation studies of test methods on a voluntary basis and to create guidance on how validation studies should be conducted. An overview of the status of the validation of alternative test methods and regulatory acceptance by ICATM members can be found in Annex II to the 2015 EURL ECVAM Status Report.

The ICCR includes various projects relating to alternatives to animal testing. 38 At the ICCR ninth annual meeting held in Brussels (Belgium) from 4 to 6 November 2015, ICCR members decided to merge the different groups dealing with alternative testing methods into a working group on safety assessment methods. The group is to have a broader focus on integrated methods and approaches to the safety assessment of ingredients used in cosmetic products.

5. Conclusion

It has been possible to prepare the present report only in 2016, as it has been based on the contributions received from Member States between 2014 and end 2015.

Virtually no cases of non-compliance with the testing and marketing bans have been reported by the Member States. The main issue encountered in their market surveillance activities related to the bans is the presence of cases of incomplete animal testing data in product information files.

However, this report covers the relatively early stages of the implementation of the 2013 marketing ban. It will be interesting to follow future developments in this field, when economic operators and market surveillance authorities gain more experience regarding the implementation of the full marketing ban. In particular, the issue of cases of incomplete animal testing data in the product information file should be monitored by the competent national authorities, as the product information file is the main way to verify compliance with the testing and marketing bans.

Considerable progress has been made in the development, validation and legal acceptance of methods alternative to animal testing. Nevertheless, some challenges remain for the most complex endpoints where more research is needed. The current level of alternative methods does not make it possible to fully replace in vivo tests for all toxicological endpoints.

Significant investments have been made in the development of alternative methods in the EU, notably through major research initiatives bringing together public and private players. The European Commission has remained engaged in the validation of alternative methods through EURL ECVAM, and in the promotion of their regulatory acceptance at OECD level and internationally.

(1)

OJ L 342, 22.12.2009, p. 59.

(2)

COM(2013) 135 final.

(3)

European Union Reference Laboratory for Alternatives to Animal Testing, Directorate General Joint Research Centre of the European Commission, previously Institute for Health and Consumer Protection, currently Directorate F – Health, Consumers and Reference Materials.

(4)

  http://bookshop.europa.eu/en/eurl-ecvam-status-report-on-the-development-validation-and-regulatory-acceptance-of-alternative-methods-and-approaches-2015--pbLBNA27474/ .

(5)

Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC), OJ L 262, 27.9.1976, p. 169, repealed by the Cosmetics Regulation.

(6)

A case on the interpretation of the marketing ban as laid down in Article 18(1)(b) of the Cosmetics Regulation is currently pending before the Court of Justice of the European Union (C-592/14).

(7)

As defined in Article 4 of the Cosmetics Regulation.

(8)

Article 11(2)(b) and (e) of the Cosmetics Regulation.

(9)

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 396, 30.12.2006, p. 1.

(10)

However, Article 30 of the Cosmetics Regulation makes it possible for the competent authority of any Member State where the cosmetic product is made available to request the competent authority of the Member State where the product information file is made readily accessible to verify whether the product information file satisfies the requirements of Article 11(2) and whether the information set out in it provides evidence of the safety of the cosmetic product.

(11)

To help address some of the issues described above, one of these Member States suggested developing a common platform to exchange information within the framework of the PEMSAC, the Platform of European Market Surveillance Authorities for Cosmetics. However, no Member State proposed to include the topic in the PEMSAC Work Programme for 2016-2017.

(12)

Among these Member States, some explicitly stated that no such cases had been encountered; the others did not specifically address this question.

(13)

This issue was, however, raised by one Member State. According to information received by this Member State from industry associations, it has become impossible to place certain cosmetic products on the market because the safety assessment of the product or one of its ingredients was not conclusive. It was, however, not always possible to say with certainty whether this was a direct result of the testing and marketing bans.

(14)

Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes, OJ L 276, 20.10.2010, p. 33.

(15)

Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes, OJ L 358, 18.12.1986, p. 1.

(16)

  http://www.seurat-1.eu/ .

(17)

  http://www.eu-toxrisk.eu/ .

(18)

Chemical assessment according to legislation enhancing the In silico documentation and safe use, http://www.caleidos-life.eu/ .

(19)

The project explored the regulatory applicability of so-called non-testing methods (quantitative structure-activity relationship (QSAR) and read-across) to substances registered under the REACH Regulation.

(20)

The revised TSAR will also cover the needs of the individual partners of EURL ECVAM participating in the International Cooperation on Alternative Test Methods (ICATM); please see section 4.2.2.

(21)

European Union Reference Laboratory for Alternatives to Animal Testing, Directorate General Joint Research Centre of the European Commission.

(22)

  https://eurl-ecvam.jrc.ec.europa.eu/ .

(23)

Not all test methods submitted would necessarily be relevant for carrying out safety assessments of cosmetic products.

(24)

For activities at OECD level, please see section 4.2.1. of this report.

(25)

  https://eurl-ecvam.jrc.ec.europa.eu/eu-netval .

(26)

Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), OJ L 142, 31.5.2008, p. 1.

(27)

Annex VIII to the Cosmetics Regulation (‘List of validated alternative methods to animal testing’) must be updated with alternative methods validated by ECVAM, which are not listed in Commission Regulation (EC) No 440/2008.

(28)

Commission Regulation (EU) 2016/863 of 31 May 2016 amending Annexes VII and VIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards skin corrosion/irritation, serious eye damage/eye irritation and acute toxicity, OJ L 144, 1.6.2016, p. 27.

(29)

EPAA 2015 Annual Report, see: https://circabc.europa.eu/sd/a/54e9ad8e-0f49-4ed0-b581-36fe6e136ce4/ar-2015.pdf .

(30)

  http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_190.pdf .

(31)

  http://ec.europa.eu/citizens-initiative/public/initiatives/successful/details/2012/000007 .

(32)

C(2015) 3773 final.

(33)

Planned for December 2016.

(34)

See section 4.1.2.2. of this report.

(35)

The OECD Extended Advisory Group on Molecular Screening and Toxicogenomics and its Adverse Outcome Pathways Development Programme.

(36)

ICATM members are agencies from the EU, the United States, Japan, Canada and South Korea.

(37)

ICCR is a voluntary international group of cosmetics regulatory authorities from Brazil, Canada, the EU, Japan and the United States.

(38)

The ICCR working group on In silico/ QSAR Models produced a report on In Silico Approaches for Safety Assessment of Cosmetic Ingredients in July 2014: http://www.iccrnet.org/files/5314/1407/7607/2014-07_In-silico_Approaches_for_Cosmetic_Product_Safety_Assessments.pdf .