REACH

Regulation (EC) No 1907/2006 – REACH – is the European Union’s chemicals regulation that entered into force in June 2007. It aims to ensure a high level of protection of human health and the environment, promote the free circulation of chemicals on the EU market, and enhance competitiveness and innovation.

REACH is comprehensive in its scope. It covers nearly all commercial products that are non food, feed or medicine. Consumer products such as clothing and footwear, jewellery, electrical and electronic products, toys, furniture, and health and beauty products all fall within the scope of REACH. This means it also applies to products already regulated by product-specific regulations such as the Toy Directive (2009/48/EC), Cosmetic Regulation (EC No. 1223/2009) and the RoHS Directive (2011/65/EU) on the restriction of hazardous substances in electrical and electronic equipment. Although REACH is a European legislation, companies outside the EU may be required to comply with its requirements due to the global nature of supply chains.

REACH stands for the Registration, Evaluation, Authorisation and restriction of CHemicals, which are the four key elements of the regulation. Each element has its own scope, set of conditions, obligations and responsible parties.

Registration

Manufacturers and importers must register any chemical that reaches the one tonne/year threshold, whether it is presented as a chemical substance on its own, as part of a mixture, or as a substance or mixture released from an article. As only a person or company established in the EU may submit a REACH registration, a non-EU company that wishes to register a chemical substance may do so by appointing an Only Representative (OR) to act on its behalf. The European Chemicals Agency (ECHA) is responsible for evaluating the information submitted in a registration.

Restriction

Each restricted substance has different conditions and scopes of restriction. For example, a harmful substance itself may be banned from being placed on the EU market, or products containing the substance up to certain concentration may be banned instead. The list of restricted substances is given in Annex XVII and is updated regularly.

Authorisation

Authorisation aims to eliminate or effectively control risks from chemicals that are particularly harmful to the human health or the environment. It is a process divided into two main stages, with each stage requiring different actors in the supply chain to carry out certain obligations:

• A substance has been identified as a Substance of Very High Concern (SVHC) and is listed in the Candidate List. If a SVHC is present above 0.1% by weight, this information is immediately communicated to the recipient of the article in the supply chain. A consumer may also request this information from the retailer and this information must be provided within 45 days. For SVHCs that are present in articles above 0.1% by weight and above 1 tonne/ year, notification to the ECHA is required. The Candidate List is updated twice per year.
• Substances on the Candidate List are then prioritised to be included in the Authorisation List (Annex XIV). Unless an authorisation has been granted, an SVHC on the Authorisation List cannot be used or imported in the EU after a specified date called the Sunset Date. Authorisation is only applicable to chemicals that are used in and/or imported into the EU and articles manufactured in the EU. However, it does not apply to imported articles.  The Authorisation list is updated approximately once per year.

All products manufactured in or imported into the EU must be compliant with all the applicable REACH requirements. It is important to remember that compliance with one requirement does not exempt the need for compliance with the others. For example, a product may need to comply with certain restriction requirements in addition to fulfilling those related to the Candidate List.

REACH has put the responsibility of demonstrating product safety onto those who place products on the EU market. For products manufactured in the EU, this responsibility falls on the EU manufacturer and downstream user. However, as REACH cannot be enforced outside of the EU, non-EU manufacturers have no direct compliance responsibilities and the job of ensuring compliance of imported products falls onto the EU importer.

Your REACH obligations are determined by the product’s classification under REACH and also your role(s) within its supply chain. Depending on the complexity of the supply chain, a company may play multiple roles for its range of products under REACH: manufacturer, producer, importer, distributor and/or retailer. The following table is a summary of the obligations, criteria and responsible party for the three key REACH requirements: Registration, Restriction and Authorisation.

Industries have increasingly recognised that REACH is much more than the sum of its individual requirements and that compliance requires strategic planning. As one of the world’s largest independent providers of testing and certification services, TÜV SÜD supports you with a customised solution for REACH compliance. We help you meet implementation timelines and different obligations for different products and actors in the supply chain.

TÜV SÜD can help your company navigate the complexity of REACH, correctly identify your obligations, and provide services and solutions to help you meet those obligations. Our comprehensive services include a full range of registration support (such as OR representative, registration dossier preparation, chemical safety report preparation and GHS/CLP-related services), chemical testing (restricted substances, substances of very high concern (SVHC)) and training (in-house training and supplier training).

A leading provider of testing and certification services, TÜV SÜD is completely independent and impartial. We are capable of performing testing and certification and can help our clients demonstrate compliance. With an international network of laboratories and multidisciplinary experts, we offer a personalised one-stop solution designed to assist you with the complex processes and issues of REACH compliance. Our experts have extensive knowledge and experience, and are fully versed in every aspect of the REACH regulation.