REACH compliance in the EU
PFA can support you with REACH compliance, delivering submission documents for non-phase-in registrations, materials for post-registration updates, or Annex level upgrades. We can support you to address evaluation feedback received from ECHA and give scientific advice for the Authorisation process.
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, or import them into the EU, either for your own use or to supply to others (even if it is for export), then you will have REACH compliance responsibilities.
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.
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 joint submission (formerly known as Substance Information Exchange Fora (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).
Why choose PFA for REACH consultancy?
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.
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 REACH registration dossiers for more than 200 phase-in substances.
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.
REACH Consortium and Joint Submission Support
PFA offers consortium management and secretariat services alongside our REACH technical consultancy services. We ensure that the deadlines of your project are met, whilst maintaining strict confidentiality at all times.
Through FWRS, consortium financial services are also available (provided by A.J.Welch F.C.A., Chartered Accountant), assessing the value of consortium members’ data assets, and administrating mutual cost-compensation, in accordance with an agreed set of impartial rules.