REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. The REACH Regulation (Regulation (EC) No 1907/2006) came into force in June 2007 and has revolutionised the way the marketing and use of chemicals are regulated in the EU. The Regulation lays down specific duties and obligations on manufacturers, importers and downstream users of substances on their own, in mixtures and in articles. It is based on the principle that industry should manufacture, import, use or place substances on the market with such responsibility and care as may be required to ensure that, under reasonably foreseeable conditions, human health and the environment are not adversely affected.
RPA was actively involved in the preparatory work for REACH, from the publication of the White Paper in 2001 through to agreement of the final provisions of the Regulation. We were also involved in a number of the REACH Implementation Projects (e.g. guidance on socio-economic analysis, for downstream users, on substances in articles, on preparation of Annex XV dossiers, and on meeting the requirements of the CLP Regulation EC No 1272/2008) and have subsequently prepared guidance for DG Environment of the European Commission on assessing health and environmental impacts as part of socio-economic analyses prepared to support REACH Authorisation or Restriction proposals.
Now that REACH has been implemented, we are providing advisory services to a variety of clients in the area of REACH Authorisations and Restrictions. We employ a very experienced and competent chemicals team, consisting of chemists, toxicologists and chemical engineers who are supported by economists and environmentalists to cover all aspects of a chemical’s lifecycle. Having supported ECHA, competent authorities and industrial clients, we have developed a detailed, tried-and-tested methodology for collecting and analysing information and preparing the necessary reports according to ECHA’s specifications. More specifically, we are recognised experts with unrivalled experience in the field of socio-economic analysis and chemical risk management. We have the necessary expertise in all of the relevant areas of work but, when appropriate, also supplement our in-house team with recognised experts from other organisations.
The types of REACH-related services offered include:
• For industry clients (trade associations, consortia of companies and individual companies): RPA provides analytical, strategic and advisory skills in relation to Authorisation and Restriction, including:
- Project management services
- Scoping services
- Updates to registration Chemical Safety Reports (in association with leading experts in the field of risk assessment)
- Supply chain communication
- Analyses of alternatives
- Socio-economic analyses
- Preparation of substitution plans
• For authorities and public bodies: RPA is capable of providing analytical and advisory skills in relation to:
- Market analyses for Annex XV dossiers (SVHC and Restrictions)
- Analyses of alternatives for Annex XV dossiers (SVHC and Restrictions)
- Development of guidance for the implementation of REACH requirements
- Provision of training
Our services are currently more focused towards supporting European industry associations and private companies, both large and medium/small enterprises. This includes working with companies or associations across a wide range of industry sectors including: bulk chemicals, ferrous and non-ferrous metals, polymers, explosives, soaps and detergents, fragrances, cosmetics, etc.
On 10 September 2015, the European Court of Justice confirmed the “once an article always an article” principle, and ruled that producers and importers of components to be incorporated into large components or final articles must notify ECHA if any of their component products contain more than 0.1% (weight on weight) of an SVHC substance. There are currently > 160 SVHC substances on the Candidate List and the formal aim is to have all identified SVHCs on the Candidate List by 2020. Furthermore, the reasons for inclusion on the Candidate list under Article 57(f) of REACH, which deals with substances of “equivalent concern” to Carcinogens, Mutagens and Reprotoxins, are expanding to include endocrine disruptors, single target organ toxicity (STOT), respiratory and sink sensitisation, with more (for example neurotoxicity) expected.
This compliance obligation will have far-reaching effects for all EU manufacturers and importers. They will need to maintain up to date lists of an ever-growing number of SVHCs and constantly review and update their notifications. At the same time, they will have to ensure that their upstream suppliers are robustly reporting any presence of >0.1% SVHC to them. A significant and costly increase in compliance administration can be anticipated.
Risk & Policy Analysts has long experience and significant expertise in helping chemicals clients manage their regulatory and compliance risks and obligations under REACH and other chemical regulations.
If you would like further information, please contact our experts below.