Annexes to COM(2018)531 - Development, validation and legal acceptance of methods alternative to animal testing in the field of cosmetics (2015-2017) - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2018)531 - Development, validation and legal acceptance of methods alternative to animal testing in the field of cosmetics (2015-2017). |
|---|---|
| document | COM(2018)531  |
| date | July 10, 2018 |
The progress of a test method from submission towards acceptance as a recognised test method for use in various sectors and its final adoption into a regulatory framework can be followed through a new version of the tracking system for alternative test methods towards regulatory acceptance (TSAR) 21 .
4.1.2.1.Evaluation and validation of test methods
In the period covered by its 2016 and 2017 status reports, EURL ECVAM evaluated 11 test submissions. It carried out or assessed (in the context of submissions) several validation studies in the areas of endocrine disruption, developmental neurotoxicity, skin sensitisation and genotoxicity. In addition, the EURL ECVAM Scientific Advisory Committee peer-reviewed validation studies carried out by the industry in the areas of (serious) eye damage / eye irritation, skin sensitisation and skin irritation.
In 2017, EURL ECVAM published a recommendation on the use of non-animal approaches for skin sensitisation (allergy) testing. The performance of a number of ‘defined approaches’ 22 based on different types of non-animal data is considered to be comparable with that of the standard animal test for identifying potential skin allergens. It was therefore recommended that these approaches be used where applicable and appropriate, instead of the standard animal test. As a consequence, a project is currently running within the OECD test guidelines programme, under the leadership of EURL ECVAM, the US Environmental Protection Agency and Health Canada, to develop a guideline based on defined approaches for skin sensitisation testing.
The European Union Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL 23 ) has supported the EURL ECVAM validation studies. It has also helped develop guidance documents and training materials for good in vitro method development and provided input into drafting OECD technical guidance on that topic.
It is worth noting that, in future, validation work may have to focus on standards for classes of methods rather than on validating individual methods.
More details on these activities can be found in the 2016 and 2017 EURL ECVAM status reports.
4.1.2.2.Regulatory uptake
Since the last Commission report, Commission Regulation (EC) No 440/2008 24 , which brings together all regulatory accepted testing methods at EU level, has been updated once 25 .
Under the REACH Regulation 26 , the in vivo tests previously required for skin irritation/corrosion, serious eye damage / eye irritation and skin sensitisation have been fully replaced by in vitro testing. The last amendment to the annex on skin sensitisation was adopted in April 2017.
4.1.2.3.European Partnership for Alternative Approaches to Animal Testing
The Commission and industry representatives continue to facilitate the regulatory acceptance of alternative methods and approaches under the European Partnership for Alternative Approaches to Animal Testing (EPAA) 27 . According to its updated action programme for 2016-2020, the EPAA plans to:
·address science and technology gaps and optimise translation from research to regulatory practice;
·improve intra- and inter-sectoral collaboration and coordination;
·facilitate regulatory acceptance of additional sources of evidence in the current regulatory framework;
·communicate scientific reality; and
·‘educate the educated’ (improve access to information, training opportunities and tools).
In 2017 the EPAA launched the Partners Forum, which provides an opportunity for all EPAA members to share information about their existing research initiatives, learn from each other’s experience and build synergies across business sectors to potentially speed up the development and acceptance of alternative methods for regulatory purposes. The 2017 forum was dedicated to toxicokinetics and ‘read-across’, and similar events will be organised annually focusing on an area that is of current common interest to several sectors.
EPAA has been very active, for example in the area of skin sensitisation in recent years, in making progress on and facilitating the uptake of alternatives. The project on optimised strategies for assessing skin sensitisation evaluated the reliability and predicting capacity of the three most advanced skin models. Other recent or ongoing EPAA projects have focused on alternative approaches for toxicokinetics (exposure), acute toxicity and genotoxicity testing, and for vaccine potency and safety assessment.
4.1.2.4.Dissemination of information on alternatives
The availability of information on alternatives is crucial. Therefore, information has been compiled in several databases at EURL ECVAM, including TSAR, the DB-ALM database on in vitro methods and the QSAR model database on in silico methods.
EURL ECVAM has also carried out a number of awareness-raising activities regarding alternatives to animal testing, such as knowledge-sharing and training.
In December 2016, the Commission held a scientific conference in Brussels to engage the scientific community and relevant stakeholders in a debate on how to exploit cutting-edge advances in biomedical and other research in the development of scientifically valid alternatives to animal testing. The event was one of the four actions announced in the Commission Communication responding to the European citizens’ initiative ‘Stop vivisection’ 28 .
4.2.Progress at international level
4.2.1.Activities at OECD level
The Commission, through EURL ECVAM, plays an active role at OECD level in the regulatory acceptance of alternative methods and their international adoption.
The OECD test guideline programme is the main instrument for promoting a globally harmonised safety assessment of chemicals 29 . From 2016 to 2017, a total of 24 new and updated test guidelines were approved, of which four were based on in vitro methods (on skin sensitisation, skin corrosion and endocrine disruption). A summary of the adoption status of test guidelines in the OECD from 2011 to 2017 based on alternative methods can be found in Annex 1 to the 2017 EURL ECVAM status report. In addition, 16 guidance documents or supporting documents were approved during that period, in particular the guidance document on the IATA to testing and assessment for serious eye damage / eye irritation, which is a basic requirement for the safety assessment of chemicals in many regulations.
Activities within the OECD working party on hazard assessment also play an important role in improving technical convergence on alternative methods at international level. OECD member countries work together to improve and harmonise assessment methodologies for chemicals and collectively gain experience in the development of IATAs which has become a priority over recent years as an alternative solution to animal testing.
4.2.2.Other international cooperation
The Commission, through EURL ECVAM, has continued its cooperation with other members of the International Cooperation on Alternative Test Methods (ICATM) 30 . An overview of the validation status of alternative test methods validated/peer-reviewed by ICATM partners and their regulatory acceptance status can be found in Annex 2 to the 2016 and 2017 EURL ECVAM status reports. In October 2016, in collaboration with ICATM, EURL ECVAM held a two-day workshop on the international regulatory applicability and acceptance of alternative non-animal approaches to the skin sensitisation assessment of chemicals used in a variety of sectors.
Since its creation, the International Cooperation on Cosmetics Regulation (ICCR) 31 has focused on advancing work related to alternatives to animal testing worldwide. At the ICCR’s 11th annual meeting held in Brasilia, Brazil from 12 to 14 July 2017, the joint regulators-industry working group on integrated strategies for safety assessments of cosmetic ingredients gave a presentation on the major overarching principles for an integrated strategy for the risk assessment of cosmetics ingredients incorporating ‘new approach methodologies’. Its document was endorsed by the ICCR Steering Committee and is publicly available on the ICCR website. Further work now continues with the objective of illustrating how these methodologies may be used in the cosmetic safety evaluation process, related to the principles, with examples of methods and their current strengths and limitations.
The Commission is involved in other international projects, for instance in the context of the UN subcommittee on globally harmonised system of classification and labelling to further explore the use of non-animal methods for classification.
The European Parliament has recently voted in favour of a resolution calling for a global animal testing ban in cosmetics 32 . The Commission will continue to promote the EU animal testing ban in cosmetics at international level, in various fora and through bilateral cooperation, including with the OECD. It will also remain fully engaged in the development, validation and promotion of methods alternative to animal testing to support the promotion of a global ban.
5.Conclusion
As in the previous reporting period, the Member States reported practically no cases of non-compliance with the testing and marketing bans. The main issue encountered by a small number of Member States in their market surveillance activities related to the bans is the presence of incomplete animal testing information in PIFs. However, corrective measures should be imposed on operators in such cases.
Considerable progress continues to be made in the development, validation and legal acceptance of methods alternative to animal testing and the Commission is fully engaged at all stages of the process. In particular, work has focused on developing defined and integrated approaches to testing and assessment which look at all existing safety data when assessing a chemical; these have become a priority in recent years.
Nevertheless, the current level of alternative methods does not yet make it possible to fully replace in vivo (animal) tests for all toxicological endpoints in the safety assessment of cosmetics. Challenges still remain for the most complex endpoints, where more research is needed. Significant projects, such as EU-ToxRisk, aim to address these challenges.
The validation of alternative methods at EU level is progressing steadily, through the activities of the EURL ECVAM. The Commission also remains engaged in encouraging the regulatory acceptance of alternative methods approved at OECD level and maintains international cooperation in this field. These activities aim not only to recognise individual alternative methods, but also to achieve the convergence of safety assessment methods at international level.
The Commission has always been highly committed to animal welfare. The EU legal framework in this regard provides for very strict requirements and represents a model to be promoted at international level.
(1)
OJ L 342, 22.12.2009, p. 59.
(2)
Some Member States reported to the Commission later than the requested deadline and also (partly) covered the year 2017.
(3)
EURL ECVAM status report on the development, validation and regulatory acceptance of alternative methods and approaches (2016 and 2017).
(4)
https://eurl-ecvam.jrc.ec.europa.eu/
(5)
Judgment of 21 September 2016 in Case C-592/14 European Federation for Cosmetic Ingredients (EU:C:2016:703).
(6)
See Article 4 of the Cosmetics Regulation.
(7)
Article 11(2)(b) and (e) of the Cosmetics Regulation.
(8)
Communication from the Commission to the European Parliament and the Council On the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics (COM(2013) 135 final).
(9)
A person who carries out the safety assessment of a cosmetic product.
(10)
Article 30 of the Cosmetics Regulation allows a competent authority of a Member State to ask the competent authority of the Member State where the PIF is accessible to verify whether the PIF is complete.
(11)
Some of these Member States explicitly stated that they were unaware of such cases or they had not encountered any; the others did not specifically address this question.
(12)
An IATA is a framework used for hazard identification, hazard characterisation and/or safety assessment of a chemical or group of chemicals, which strategically integrates and weights all relevant existing data and guides the targeted generation of new data where required to inform regulatory decision-making regarding potential hazard and/or risk.
(13)
See Section 4.1.2.1.
(14)
http://www.seurat-1.eu/
(15)
http://www.eu-toxrisk.eu/
(16)
Toxicology in the 21st century.
(17)
https://www.euromixproject.eu/
(18)
http://edcmixrisk.ki.se/
(19)
https://www.hbm4eu.eu/
(20)
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).
(21)
https://tsar.jrc.ec.europa.eu/
(22)
A defined approach consists of a fixed data interpretation procedure applied to data generated with a defined set of information sources to derive a result that, depending on the regulatory requirements, can be used instead of standard animal testing to support an assessment.
(23)
https://eurl-ecvam.jrc.ec.europa.eu/eu-netval
(24)
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).
(25)
Commission Regulation (EU) 2017/735 of 14 February 2017 amending, for the purpose of its adaptation to technical progress, the Annex to Regulation (EC) No 440/2008 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 112, 28.4.2017, p. 1).
(26)
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).
(27)
EPAA annual report 2017; http://ec.europa.eu/docsroom/documents/26811
(28)
http://ec.europa.eu/citizens-initiative/public/initiatives/successful/details/2012/000007
(29)
The methods for which OECD test guidelines are adopted are legally implemented at EU level through Commission Regulation (EC) No 440/2008.
(30)
ICATM is an international cooperation that includes governmental organisations from the EU, the United States, Japan, Canada, South Korea, Brazil and China. ICATM partners work together to promote enhanced international cooperation and coordination on the scientific development, validation and regulatory use of alternative approaches.
(31)
ICCR is a voluntary international group of cosmetics regulatory authorities from Brazil, Canada, the EU, Japan and the United States founded in 2007. It discusses common issues on cosmetics safety and regulation and is in dialogue with relevant cosmetics industry trade associations; http://www.iccr-cosmetics.org/
(32)
European Parliament resolution of 3 May 2018 on a global ban to end animal testing for cosmetics (2017/2922(RSP)).