The REACH regulation is the Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (EC) 1907/2006, which entered into force on the 1 June 2007. The Regulation was introduced because the hazardous properties of many chemical substances on the EU market had not been properly evaluated.

REACH makes industry, rather than regulators responsible for establishing the health, safety and environmental properties of substances, which must be submitted to the European Chemicals Agency, ECHA with registration. The level of information required depends on the volume tier registered, but ECHA may request further detail from ongoing REACH processes.

REACH registration duties apply to EU manufacturers and EU based importers of substances from outside the European Union (EU), produced or imported in quantities exceeding 1 tonne or more per annum (1 t/a). Substances that are intentionally released from articles are also subject to registration. Product mixtures do not need to be registered, but importers must collate the volume of constituent substances and register those substances that exceed 1 t/a .This could be expensive if several constituent substances exceed the threshold.

Suppliers from outside the EU are not permitted to register directly, but may appoint an ‘Only Representative’ in Europe to act on their behalf. For non EU suppliers, this option prevents any potential issues with disclosure of intellectual property and protects supply to the EU market. This also frees their EU importing customers, who are then considered downstream users without registration duties.

REACH has been managed in a phased approach for existing substances on the EU market. The final registration deadline for lower volume substances  (1-100 tonnes) has now passed. REACH registration now applies only to new substances above volume threshold. However, existing registrants are required to update their registrations without undue delay (according to Article 22 of REACH) with relevant new information, which must be submitted to ECHA.

ECHA co-ordinate substance evaluation processes, through the Committees represented by each of the EU Member States.

Following evaluation, some substances may be subject to authorisation of use.

These are substances deemed substances of very high concern (SVHC) that meet the following criteria:

  • classified as carcinogenic, mutagenic or toxic to reproduction (CMR), category 1A or 1B; 
  • meet the criteria of persistent, bio-accumulative and toxic (PBT), or very persistent and very bio-accumulative (vPvB);
  • are identified as potentially causing serious effects to humans or environment of an equivalent level of concern to those previously mentioned e.g. endocrine disruptors.

Candidate List substances of very high concern eventually subject to authorisation cannot be used without specific approval, unless it can be demonstrated that the socio-economic benefits outweigh the risks and there are no suitable alternative substitutes or technologies. 

Downstream users also have key responsibilities because REACH is concerned with all elements of the supply chain. A downstream user may be a manufacturer of mixtures, an end user, importer with an OR in place, re-importer, re-filler or producer of articles. This group has played an important role in identifying the uses of their substance for registration purposes. 

Downstream users that supply hazardous substances or mixtures must communicate information on safe use to their customers. They must also communicate relevant information that they establish on the hazardous properties of a substance, or suitability of risk management measures upstream.

Downstream users of authorised substances must use the substance within the conditions of that authorisation. They may also apply for an authorisation, should suppliers being unwilling to do so. 

Article manufacturers must also notify ECHA if their article contains a SVHC above 0.1% wt/wt under the following conditions:

  • exposure cannot be excluded under normal conditions of use including disposal;  
  • the substance is used above the 1 tonne per annum threshold value and;  
  • the substance has not already been registered for that particular use. 

When a Candidate List substance is present in an article above 0.1%, the article manufacturer must provide the recipient of the article, or on the request of a consumer, sufficient information to enable the safe use of the substance.

Now we have passed the final phase-in registration deadline for existing substances, new substances will require registration, and existing substances that tip the 1 tonne threshold. REACH registration for polymers is currently under consideration. More to come on this.
Page updated 02 January 2020