REACH Compliance Testing

REACH (Registration, Evaluation, Authorization, and restriction of Chemicals) (Regulation (EC) No 1907/2006) is the EU’s chemicals regulation. REACH aims to ensure a high level of protection for human health and the environment, promote the free circulation of chemicals on the EU market, and enhance competitiveness and innovation. 

The REACH Regulation requires companies to report on chemicals used in their products and throughout the supply chain. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. 

Now that the United Kingdom has left the European Union, UK REACH has come into law. There are many similarities and differences in the requirements for hazardous substances in articles under EU and UK REACH. You can find out more here.

Any person or company producing, importing or processing a chemical substance is affected by REACH.

Companies manufacturing or importing chemical substances above one tonne a year are responsible for collecting information on the properties and uses of the substances they. They are also required to assess the hazards and potential risks presented by the substance.

A registration dossier containing the hazard information and, where relevant, an assessment of the risks that the use of the substance may pose and how these risks should be controlled, is submitted to ECHA.

Registration applies to substances on their own, substances in mixtures and certain cases of substances in articles. Registration is based on the "one substance, one registration" principle. This means that manufacturers and importers of the same substance have to submit their registration jointly.

• EU manufacturer or importer of substances on their own or in a mixture
• EU producer or importer of articles meeting the criteria explained in the Guidance on requirements for substances in articles
• "Only representative" established in the EU and appointed by a manufacturer, formulator or article producer established outside the EU to fulfil the registration obligations of importers

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 REACH evaluation provisions give ECHA the responsibility to check whether registrations are in compliance with the requirements of this Regulation. Evaluation focusses on:

• Examination of testing proposals submitted by registrants
• Compliance check of the dossiers submitted by registrants
• Substance evaluation
  

Authorization 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 customer 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 may be necessary. The Candidate List is updated twice per year. 
• Substances on the Candidate List are then prioritized to be included in the Authorization List (Annex XIV). Unless an authorization has been granted, an SVHC on the Authorization List may not be used or imported in the EU after a specified date called the Sunset Date. Authorization is only applicable to chemicals that are used in and/or imported into the EU, and it does not apply to imported articles. The Authorization list is updated approximately once per year.
  

Restrictions are normally used to limit or ban the manufacture, placing on the market (including imports) or use of a substance, but can impose any relevant condition, such as requiring technical measures or specific labels. 

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

Substances of very high concern (SVHCs) are substances deemed to have serious or irreversible negative effects on human health and the environment. If a substance is identified as an SVHC, it may be added to the Candidate List for eventual inclusion in the Authorization List (Annex XIV).

If a SVHC is present above 0.1% by weight, this information is immediately communicated to the customer in the supply chain. For SVHCs that are present in articles above 0.1% by weight and above 1 tonne/year, notification to the ECHA may be necessary. 

If a substance is identified as an SVHC, it is added to the Candidate List. The inclusion in the Candidate List brings immediate obligations for suppliers of the substance, such as:

• Supplying a safety data sheet
• Communicating on safe use
• Responding to consumer requests within 45 days 
• Notifying ECHA if the article they produce contains an SVHC in quantities above one tonne per producer/importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w).

The Candidate List is updated twice per year.