If you would like help with REACH registration planning, testing or dossier preparation contact us.
- Alchemy Compliance can advise on all aspects of the REACH registration.
- Literature searching, structure–activity relationships, and testing strategy.
- Chemical safety assessment.
- Dossier compilation in IUCLID format for registration.
- UK-REACH notification, registration, and ‘only representative’ services.
The stated aims of the EU REACH (Registration, Evaluation, and Authorisation of Chemicals) legislation (1907/2006 as amended) are seven-fold:
- Protection of human health and the environment
- Enhancement of the competitiveness of the EU chemicals industry
- Prevention of fragmentation of the internal market
- Increased transparency
- Integration with international efforts
- Promotion of non-animal testing
- Conformity with EU international obligations under the WTO.
These aims are in line with the principles of sustainable development: namely economic (industrial competitiveness), social (health protection and jobs), and environmental.
REACH registration applies only to substances, so the first step in REACH compliance is to determine the identity and amount of each substance that the supplier manufactures or imports from outside the EU. Therefore an importer of a mixture has to have full information on the composition of the mixture. If an importer imports multiple mixtures containing the same substances then the amount for that substance is aggregated.
REACH mandated chemical manufacturers and importers to determine the hazardous properties of thousands of older substances under the ‘no data, no market’ principle. The transition period for registration of older ‘phase-in’ chemicals ended in May 2018. The hazard and use data has been registered with the European Chemicals Agency (ECHA), and published on the ECHA website thereby greatly increasing the amount and quality of publicly available hazard information.
New manufacturers or importers of previously registered substances are still required to make a registration, unless exemptions apply. They should make an inquiry to ECHA to be put in touch with data holders, in order to share data and reduce animal testing. This data, plus the company-specific information (eg commercial information and analytical data) form the basis of a new registration dossier, under the ‘one-substance, one-registration’ principle.
New chemicals requiring registration, ie newly manufactured in the EU or imported from outside the EU for the first time, at above 1 tonne per year require registration under REACH. The potential registrant has to make the inquiry to ECHA to confirm there are no previous registrations for the substance. If there is no previous registration, then the registrant has to fulfil the data obligations through testing or alternative methods, and compile a registration dossier. Only when the dossier is accepted can the registrant begin supply of the substance.
UK REACH and Brexit
The UK government’s preferred plan is for a negotiated agreement with the EU, with a transition period from 29th March 2019 to 31 December 2020 in which to discuss the future relationship with the EU. During the transition period, the rules governing chemical supply, such as the REACH and CLP Regulations continue, so there is no disruption to supply chains.
In the future relationship discussion document, the UK government indicates its intention to partner with ECHA even after the transition period, to allow REACH registrations made by UK companies to continue to be valid within the EU.
In the event of a no-deal Brexit, or the lapse of the transition period without special arrangements, REACH registrations held by UK companies will no longer be valid. The UK registration holder should transfer the registrations they hold, using the REACH IT system, to a company in one of the remaining EU countries that could then act as an EU importer. If the UK company has multiple importers based in the EU, then the UK company can appoint an EU ‘only-representative’ to cover the importers’ registrations.
Post Brexit, a UK company importing substances at above 1 tonne/year from the EU, either neat or in a mixture, would need to register the substances under ‘UK REACH’. The process is described in draft legislation as a two-step process.
- Enter basic information into the new UK REACH-like IT system
- Within two years (currently 29 March 2021), the company should submit a full dossier (including robust summaries of the test data that many joint-registration holders may not have easy access to)
When is REACH Registration required?
Manufacturers and importers are obligated to register hazard and use information on their chemical substances marketed at above 1 tonne per year. The suppliers use the data to ensure safe use of their products throughout their lifecycle. A formal risk assessment document, the Chemical Safety Report, is required for substances supplied at > 10 tonnes/year.
Certain substances are exempt from registration:
- Substances ‘regarded as registered’: notified new chemicals (ie under previous scheme, until next tonnage threshold is reached); biocide, pesticide, medicinal active ingredients, etc, that are regulated under separate legislation.
- Well-known, low risk substances (eg some sugars, fatty acids, glycerides, noble gases) (REACH Annex IV)
- By-products, impurities, or degradation products (Annex V)
- Non-dangerous, unmodified natural products (Annex V)
- Polymers (but the monomers require registration if present at >2 wt% in combined form and > 1 tonne) (Article 6.3)
- Experimental products: eg product and process oriented research and development (PPORD; Article 9); 5 year exemption from registration, require listed customers and research purposes.
A ‘light’ registration only is required for site-limited intermediates, and those transported between sites under controlled conditions.
The registration dossier comprises:
- A technical dossier
- A chemical safety report (only for substances supplied at >10 t/a)
The technical dossier contains the following information on the substance (see Article 10):
- Applicant information
- Substance identification
- Manufacturing process and uses
- Classification and labelling
- Human exposure
- Recommendations for safe use
- Properties (physico-chemical, toxicological, and ecotoxicological) according to the lists given in REACH Annexes VII to X. The information requirements depend on the marketing tonnage.
- Other information already available.
Chemical Safety Report
A chemical safety report is required for substances marketed at > 10 t/a. It comprises:
- Hazard classification
- Assessment of the substance as persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB)
- For all hazardous, PBT, or vPvB substances: development of exposure scenarios and risk characterisation, for for all ‘identified uses’ during lifecycle of the substance.
The Agency (ECHA, the European Chemicals Agency) will usually perform only simple completeness checks on the registration dossier, and ensure the registrant has paid ECHA’s fees, before accepting the dossier and issuing a registration number, although some dossiers will be more thoroughly evaluated.
Evaluation has two-steps:
- Administrative: the Agency evaluates the dossier, with regard to both the testing proposals, particularly for substances supplied at > 100 tonnes/year (REACH Annex IX data), and compliance with the regulatory requirements for registration.
- Technical: the Agency evaluates the substance for risks to human health or the environment. The Agency can ask for further information if safety cannot be assured.
- Category 1 and 2 carcinongens, mutagens and reprotoxic substances (CMRs)
- Persistent, bioaccumulative, and toxic substances (PBTs)
- Very persistent, very bioaccumulative substances (vPvBs)
- Substances identified as having serious and irreversible effects to humans or the environment (eg endocrine disrupting chemicals, EDCs)
Authorisation is a two-step process:
- Administrative: the Agency decides which substances, and also which uses, will require authorisation. The Agency prioritises the substances and set deadlines for the provision of information by industry.
- Technical: The applicant will have to demonstrate that the hazards of such substances are adequately controlled through risk management, and no safer alternatives exist, in a socio-economic analysis (SEA). The Agency will provide an expert opinion on the analysis, and grant an authorisation if this if favourable.
Where manufacturers or importers do not demonstrate adequate control of the risks, then the Commission imposes restrictions on the marketing or use of such products. The authorisation process gives a sunset date, beyond which the substance cannot be used unless a specific authorisation is granted. The substances, authorisations, and sunset dates are listed in REACH Annex XIV.
REACH Annex XVII lists restrictions for substances that do not warrant a ban, but can be adequately controlled through other means, such as the restricting the type of user, or product, or concentration, or use pattern,
or requiring special labelling.