reach compliance experts

REACH

What is REACH?

REACH is a European Union regulation on the Registration, Evaluation, Authorisation and restriction of Chemicals, which was implemented in June 2007. REACH has replaced a number of different chemical regulations with a single system, which aims to protect human health and the environment through improved identification of the properties of chemical substances. REACH gives more responsibility to the chemical industry in risk management and safety information. It requires manufacturers and importers to gather information on the properties of their chemical substances and to register the information in a central database run by the European Chemicals Agency (ECHA).

Following successful registration, the regulatory submission must be kept up to date with new information including any changes to chemical safety assessment. A registrant must be prepared to maintain the information in their dossier and also to react to information requests from ECHA. Furthermore, if the marketed tonnage increases to the next tonnage band, additional information is required.

What is my responsibility under REACH?

If you make chemicals, either for your own use or to supply to others (even if it is for export), then you are classed as a manufacturer, and will have REACH compliance responsibilities. If you import chemical substances from outside the EU/EEA, you may have some responsibilities under REACH. Phases 1 and 2 of REACH, concerning chemical substances manufactured or imported at 100 tonnes or more per year, are now closed. Phase 3 concerns chemical substances manufactured or imported at 1-100 tonnes per year. The deadline for registration of Phase 3 substances is the 1st June 2018. Registration under REACH involves providing ECHA with a dossier containing hazard information and, where relevant, a risk assessment of the uses of the substance. REACH works on the principle of ‘one substance, one registration’, thus manufacturers and importers of the same substance should normally submit their registrations jointly. This is done through the formation of Substance Information Exchange Fora (SIEF). For more information on the REACH registration process and how PFA can help with REACH compliance, see our flowchart and information on our service package.

ECHA can evaluate a registration dossier in which test proposals are examined and compliance checks are made, to ensure that the information in the dossier is compliant with the legal requirements. If further information is requested, a statutory deadline is set for the registration dossier to be updated. The lead registrant may have responsibilities to interact with co-registrants in the SIEF, to agree a course of action to address such decisions. (For more information on evaluation, see http://echa.europa.eu/regulations/reach/evaluation/evaluation-procedure).

In this context it is sensible for registrants to maintain dossiers after registration, so that any vulnerability is addressed quickly. Registrants should also bear in mind that some information from a registration dossier is published on ECHA’s website within a few weeks after registration. Identified mistakes and issues should be corrected without delay.

Why choose PFA for REACH consultancy?

PFA has the capability to undertake technical services and facilitate data access arrangements, in support of REACH compliance with many aspects of the REACH requirements. We have developed dossiers for over 150 substances for Phases 1 and 2 of the REACH Phase-In submission programme, and are working on producing dossiers for around 100 substances for the 2018 deadline. As well as this extensive work for REACH registrations, we have twenty years’ experience in developing dossiers. PFA knows how to apply best scientific knowledge to develop robust and complete dossiers, which is essential for both regulatory acceptance and cost savings. Our understanding of scientific techniques and practical context enables us to make the best use of existing information, and to ensure that testing programmes are appropriate. We have expert knowledge of chemistry, degradation in the environment, toxicology and ecotoxicology, and thus can process dossier information correctly and with confidence. PFA is pleased to be an approved Service Provider to REACHReady, a Chemicals Industry Association service network. For more information on our REACH service package, please click here. Please get in touch with any further enquiries. Please take a look at our diagram explaining the REACH registration process and how PFA can help.