STANDARDS & REGULATIONS
importance of using existing data, modelling and read-across techniques.
REACH ensures that a safety data sheet accompanies the product throughout the supply chain so that downstream users of the chemical know that it is safely managed.
“TO DATE,
OVER 15,000 SUBSTANCES HAVE BEEN
REGISTERED.”
REACH: GLOBAL IMPACT Jukka Malm, Director of Assessment at ECHA, has noted that signs of the global effects of REACH are emerging, and that companies are working around the world on the regulation; developing information, assessments, tools and experiences.
and safer alternatives or, if these do not exist, a research and development plan. Restrictions may be placed on a given hazardous substance, and in this case, the substance may not be manufactured or used or put on the market unless it complies with the conditions of the restrictions.
REACH obliges registrants to supply a chemical safety assessment (CSA) to ECHA as part of the registration dossier. The principle of CSA is to determine that all chemicals are “fit for purpose” based on the assumption that all chemical substances may be used safely, even if they are highly hazardous, provided that exposure can be maintained below acceptable limits.
Full regulatory testing for environmental and health effects must be performed in compliance with international good laboratory practice and a large amount of guidance has been provided to cover the “intelligent test strategy” to ensure that animal testing is minimised by stressing the
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REACH data is publicly available and can be used by countries and programmes worldwide. This is further enhanced by the fact that REACH information is based on OECD methodologies and contributes to agreed global chemical management goals.
REACH provides many opportunities for greater co-operation and “is already a global reference when developing chemicals management systems”, Mr Malm says.
The Candidate List has become a key reference for global substitution efforts.
The ECHA has also said that it intends to carry on working hard to meet the UN’s World Summit on Sustainable Development (WSSD) for 2020 to ensure that chemicals are used and produced in ways that minimise significant adverse effects on human health and the environment.
HAZARD COMMUNICATION
IMPROVEMENTS According to the ECHA’s report on the operation of REACH and Classification, Labelling and Packaging (CLP), it
appears that companies are dedicating increasing attention and effort to improving communication in the supply chain, such as when larger companies help their suppliers refine their SDS, check the supplied data against in- house databanks or otherwise improve their interaction on safe use with their business partners. This is based on feedback from ECHA’s SME visits’ programme in 2015 and information from individual companies.
Available indications attest to increasing worker awareness of safety requirements, better co-operation of companies with (sectorial) industry associations, and a groundswell of improvements overall in supply chain communication.
In a survey by the European metal industry association, 60% of respondent companies acknowledged that REACH has helped them communicate the hazards and risks of the substances they manufacture and to become more proactive on chemicals management.
ALTERNATIVES
TO ANIMAL TESTING As a final illustration of the impact of REACH, ECHA’s report on the use of alternatives to animal testing shows that most registrants consider and use alternatives to animal testing with alternatives being used for at least one endpoint in 89% of the substances analysed. One effective way in which this has been achieved is through data sharing, where 98% of substances being registered jointly. Registrants also make extensive use of existing information and alternative methods before conducting new studies.
Commenting on the milestone, ECHA’s Executive Director, Geert Dancet says, “We can collectively look back with pride on the last 10 years. This is a massive achievement in protecting human health and the environment. But let’s not leave it there. Let’s look with the European Commission at what can be done even better. This is important work which affects every single one of us. We’ve made an excellent start, but we need to maintain the level of ambition that was set by the Member States over a decade ago.”
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