Safety Assessment of Chemical Substances (CSA, Chemical Safety Assessment)
Every Brazilian company that exports its ingredients to European Union member countries must have its documents up to date, in accordance with the requirements required by REACH.
REACH stands for Registration, Evaluation, Authorization and Restriction of Chemicals, came into force on 06/01/2007, and is managed by the European Chemicals Agency (ECHA). It is a regulation focused on improving the protection of human health and the environment against the risks that can be posed by chemicals, while increasing the competitiveness of the EU chemical industry.
In principle, REACH applies to all chemical substances; not only those used in industrial processes, but also in our daily lives, for example cosmetic ingredients. Therefore, the regulation impacts the majority of companies across the EU. To comply with the regulation, companies must identify and manage the risks associated with the substances they manufacture and market in the EU. They must demonstrate to ECHA how the substance can be used safely and must communicate risk management measures when handling ingredients during the manufacture of the cosmetic product. If risks cannot be managed, authorities can restrict the use of substances in different ways. In the long term, the most dangerous substances will have to be replaced by less dangerous ones.
Furthermore, the safety assessment of a chemical substance (and its mixtures) used in the production of cosmetics must also follow the guidance notes for testing cosmetic ingredients and their safety assessment (SCCS/1467/22). The SCCS is a document compiled by members of the Scientific Committee on Consumer Safety. The document contains relevant information on different aspects of testing and evaluating the safety of cosmetics in Europe. The emphasis of this guidance is on cosmetic ingredients, although some guidance is also provided indirectly for evaluating the safety of finished products.
An important development in recent years has been the full implementation of cosmetic legislation, Regulation (EC) No. 1223/2009, which means that animal testing and marketing bans apply in full from 2013: no testing in vivo of finished products after 03/11/2004; no test in vivo for local toxicity after 3/11/2009 and no testing in vivo for repeated dose toxicity (including sensitization), toxicokinetics and developmental toxicity as of 03/11/2013 for cosmetic purposes. For this reason, the SCCS has closely monitored the progress made in the development and validation of alternative methods, with an emphasis on replacement methodology.
SCCS/1467/22 includes the latest validated methods of the 3Rs (Refinement, Reduction, and Substitution) (Russell & Burch, 1959), with an emphasis on Replacement and New Approach Methodologies (NAMs). Taking into account the testing and marketing prohibitions provided for in cosmetic regulations, SCCS pays special attention to alternative methods that are suitable for safety testing of cosmetic substances without the use of animal testing. New methodologies for assessing the risks of chemical products without using animal testing are being explored around the world. Attention is given here to the Next Generation Risk Assessment (NGRA) as a possible framework for evaluating the safety of cosmetic ingredients and the NAMs that would fall within this framework. Risk assessment of cosmetics and their ingredients is evolving towards a strategic combination of NAMs and new technologies with historical animal data, where available, to arrive at a Weight of Evidence (WoE) decision-making approach.
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