REACH obliges all companies manufacturing or importing substances in the European Union in quantities of 1 tonne or more per year to submit a registration to the European Chemicals Agency (ECHA), prohibiting the commercialisation of unregistered substances.
Non-EU companies cannot submit a REACH registration for substances they export to the EU. Instead, they can appoint a European company as their Only Representative to apply for REACH registration. In this way, European importers purchasing this substance from them will be considered as downstream users for the purposes of REACH.
It will therefore be the responsibility of manufacturers, importers and downstream users of these substances to ensure that they only manufacture, market or use substances that do not adversely affect human health or the environment. One of the key documents for doing this effectively is the Safety Data Sheet.
The Safety Data Sheet is the main tool used in the chemical industry to transmit information on the risks of hazardous substances and mixtures throughout the supply chain. Annex II of the REACH Regulation (as currently amended by Regulation 2015/830) sets out the information to be included in each of its 16 sections.
ServiREACH gives you the support you need to comply with the REACH Regulation in all the member states of the European Union.
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The REACH Regulation (EC) 1907/2006 is mandatory for all European companies that manufacture, import or use chemical substances in the EU/EEA. If your company falls into this category, you should review your specific obligations and document your compliance. Failure to comply may result in possible consequences legal sanctions. At ServiREACH we carry out an initial diagnosis to determine your exact obligations according to your activity.
Non-EU companies cannot directly submit a REACH registration. However, to avoid giving up on the European market, they can designate an Only Representative (OR) established in the EU to act on your behalf and execute this registration. ServiREACH acts as your Exclusive Representative, assuming all registration obligations on your behalf. This allows your European customers to be considered “intermediary users” (relieving them of the registration burden they would have as importers) and facilitates the entry of your products into Europe without administrative barriers.
It is not always necessary to satisfy the legal requirements for information on substances through experimental testing. At ServiREACH we use alternative and regulatoryly accepted strategies such as computational studies (QSAR models) and data extrapolation (read-across).. These techniques allow us to predict the physicochemical and toxicological properties of your substances without the need for new animal or laboratory tests, significantly reducing the economic cost, the ethical impact, and the time required to prepare a registration dossier.
The Safety Data Sheet is the primary tool for communicating the risks of a substance or chemical mixture throughout the supply chain. It is not merely a formality; it must strictly comply with Annex II of the REACH Regulation (and its amendments, such as Regulation 2020/878). We not only create the SDS, but we also adapt them to all languages and specific regulations of each EU country where you operate, ensuring that manufacturers, importers, and downstream users have the mandatory and up-to-date safety information.
Yes, we offer a service called Compliance Study.. During this process, we assess how the REACH Regulation affects each of your current products and analyze their legal status. If we detect irregularities, we compile a list of corrective actions and we define a strategy to regularize your situation. In addition, we conduct preliminary economic studies so that you know the profitability and costs associated with any registration before making the investment.
Any industry sector that handles chemical products needs to understand its responsibilities under REACH. We can help you identify and comply with them. Are you interested?
