A REACH registration package needs to be supported by a standard set of data on that substance. Enviresearch can assist in finding solutions for any data deficiencies, offer strategic advice on compliance for your substance or product portfolio and provide representation in your substance information exchange forum (SIEF) or consortium.
Enviresearch’s expert team covers the full spectrum of technical areas needed to complete a REACH registration dossier, including classification and labelling and PBT assessment, uses and exposure, physical and chemical properties, environmental fate, ecotoxicology, human toxicology and analytical methods. Our REACH submission services include inquiry dossiers (Article 26), full registration dossiers (for any tonnage range, either as a joint registrant or lead registrant), as well as post-submission support to maintain an up-to-date dossier.
For EU and UK REACH submissions, technical dossiers need to be compiled using the International Uniform Chemical Information Database (IUCLID) platform for storing and retrieving detailed hazard information concerning chemical substances. Enviresearch has a wealth of experience in preparing REACH technical dossiers and navigating IUCLID and can aid with all IUCLID submission types.
SVHCs are substances that have hazards with serious consequences. For example, they are classified as carcinogenic, mutagenic or reprotoxic or classed as persistent chemicals that can accumulate in the environment. These substances require authorisation as opposed to registration, meaning they are often authorised for specific uses, e.g., industrial use only. Additional data and sound scientific justification needs to be presented for these substances to be listed on the UK/EU candidate list for authorised substances. Our team of experts are well placed to advise on and provide such justification for the risk assessment of these concerning substances.
A CSR needs to be completed under REACH for each substance registered at or above 10 tonnes per year and sets out exposure scenarios relevant to user safety. In addition, exposure assessment and risk characterisation for substances classified as dangerous or as having persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) properties need to be presented for evaluation. Our team of experts can perform exposure assessments covering all necessary areas, including human health, environmental fate and ecotoxicology assessments.
Data sharing under REACH is the core principle to avoid unnecessary testing on animals and reduce registration costs. Registrants are placed in a substance information exchange forum (SIEF) with registrants of the same substance to facilitate the exchange of information, agree on classification and labelling and negotiate costs of shared data packages. Acting as a trusted third party, Enviresearch can represent your interests in the SIEF, using our knowledge of regulatory procedures, technical expertise and data-sharing experience.
The responsibility of REACH registrations is placed on the UK/EU-based legal entity that manufactures or imports the substance. However, non-EEA-based companies may wish to take on the registration responsibilities themselves for commercial reasons. In this scenario, an ‘only representative’ (OR) based in the intended market is needed to hold the registration and be responsible for its upkeep. With offices in the UK and EU (Portugal), Enviresearch can offer OR services in both regions.
REACH registrations must include a data package that sufficiently addresses the data requirements as laid down in the annexes to the REACH regulation. If registering a new substance or an existing substance in a higher tonnage band, then gathering and presenting this data will be the responsibility of the registrant. Enviresearch offers a comprehensive data gap analysis service to determine which studies need to be performed and the necessary details to be presented to ensure the submission of a compliant data package.
In the EU and UK, the UN globally harmonised system (GHS) for the classification and labelling of chemicals is applied via the classification, labelling and packaging (CLP) regulation. Therefore, SDSs for products in the EU/UK need to reflect CLP guidance and procedures. We provide thorough SDS review assistance as well as a square one complete authoring service for new SDSs and can offer notification services such as poison centre notification (PCN) or classification updates using the IUCLID platform.
The RSK group is a leading integrated environmental, engineering and technical services business offering bespoke end-to-end solutions to a variety of sectors. Headquartered in the UK but with an established presence throughout Europe, Africa, the Middle East, Asia and Australia, RSK helps organisations around the world achieve their business aspirations in a sustainable and efficient manner.
