EU REACH regulation
REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals EC/1907/2006) was introduced by the European Union in 2006 to mitigate risk of hazardous chemical substances to human health and the environment. Considered one of the most comprehensive chemical regulations in the world, its rules may apply to any company that imports, manufactures or uses chemicals or articles in the European Economic Area (EEA).
What are the REACH requirements?
The European Chemicals Agency (ECHA) manages the technical, scientific and administrative aspects of implementing REACH. Numerous pages of guidelines are available on the regulation but this can be difficult to navigate as REACH compliance means different things to different companies along the EU chemicals supply chain. Furthermore, establishing compliance is not as simple as obtaining a ‘REACH certification’, instead proving compliance means demonstrating to the enforcement authorities that your company has fulfilled all applicable obligations. Confirming your company’s role in the supply chain is a good start for identifying your REACH requirements.
TSG Consulting can help
TSG’s REACH regulatory consultants have many years’ experience working in the chemical industry and have guided chemical companies through every aspect of their REACH obligations since its introduction. Our REACH services are provided by an expert team of regulatory managers, human health scientists, ecotoxicologists, chemists and risk assessors who deliver regulatory and scientific support.
Importers and manufacturers have a duty submit a REACH registration via the REACH IT portal, with supporting information related to the properties of that chemical substance where the amount of information needed is proportional to the volume of use and hazard profile. ECHA maintains a database of all REACH registered substances and the non-confidential information is freely available to everyone.
TSG offers a full and bespoke registration service. We can create full or partial registration dossiers and send them to you for submission, or submit on your behalf.
Once registered, some chemical substances will undergo an evaluation by either ECHA or the Member State Competent Authorities. After this process, no action may be taken, further testing may be required or a substance can be nominated as a substance of very high concern (SVHC). If identified as a REACH SVHC, the substance will be placed on the REACH candidate list for authorisation. Once here, users of the chemical will have specific obligations to fulfil.
TSG can support clients throughout the evaluation process, undertaking assessments to identify and carry out actions that should give your substance the best chance for an appropriate evaluation by the authorities.
If deemed necessary, the substance will be placed on Annex XIV, also known as the REACH authorisation list. This means that the SVHC will be illegal to sell or use in the EEA after the sunset date unless an exemption applies or an authorisation is granted by the European Commission.
For authorisation applications, TSG has developed a phased process to give the best chance to compile and submit the authorisation dossier before the substance’s latest application date. We can also manage communications with all stakeholders so that expectations are clear. As granted authorisations are time-limited, TSG can support the creation of review reports should you require the substance for longer.
Another risk management route is to place the substance on Annex XVII, also known as the restriction list. Here, a substance restriction may be given certain derogations so an interpretation is often required to identify compliance tasks. One such example is lead and its compounds where, among numerous conditions, it shall not be placed on the market in jewellery in concentrations equal to or greater than 0.05% by weight.
TSG can advise on your uses of restricted substances to certify that you are complying with the regulation.
Actors that are based outside the EEA are required to appoint an Only Representative (OR) to fulfil the requirements of the REACH directive on their behalf. The EEA legal entity can submit REACH registrations, applications for authorisations or other notifications that may be required.
TSG provides Only Representative services where our dedicated specialists can advise, generate and submit all REACH notifications to ECHA.
The EU REACH regulation contains 849 pages of text, significant portions of which are important for companies that manufacture or import chemicals and articles in the EEA. TSG Consulting has many years’ experience helping companies navigate the legislation, identifying the key REACH requirements for each client. Get in contact with one of regulatory specialists today.