Compliance and safety for the supply of chemical products
REACH
What improvements will REACH achieve?
The stated aims of the proposed REACH (Registration, Evaluation, and Authorisation of Chemicals) legislation 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.
The most significant impact of the REACH scheme is to mandate chemical manufacturers and importers to determine the hazardous properties of thousands of older industrial chemicals, bringing to an end the previous distinction between ‘existing’ and ‘new’ chemical substances. Thus the available information about chemical products will be greatly increased.
What will industry be required to do?
Registration
Manufacturers and importers are obligated to obtain hazard information on their chemical substances marketed at above 1 tonne per annum. The suppliers use the data to ensure safe use of their products throughout their lifecycle.
Certain substances are exempt from registration:
‘Regarded as registered’ products: 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.
Low risk substances (eg some sugars, fatty acids, glycerides, noble gases) (Annex IV)
By-products, impurities, or degradation products (Annex V)
Non-dangerous natural products (Annex V)
Polymers (but the monomers require registration if present at >2% in combined form and > 1 tonne)
Experimental products: product and process oriented research and development (PPORD; Article 9); 5 year exemption from registration, required listed customers and limited amount.
A 'light' registration only is required for site-limited intermediates, and those transported between sites under controlled conditions.
The registration documents comprise:
-
A technical dossier
A chemical safety report (only for substances supplied at >10 t/a)
Technical Dossier
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 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 chemicals 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: exposure assessment and risk characterisation, for the lifecycle of the substance, for all ‘identified uses’.
Registration timetable
Manufacturers and importers are expected to register ca. 30 000 ‘phase-in’ substances (usually those listed in EINECS, but see Article 3.20) during the 11 year transition period of REACH, according to the timetable below. Non phase-in substances have to be registered before they can begin to be marketed. The Agency (ECHA, the European Chemicals Agency) will usually perform only a simple completeness check, although some dossiers will be more thoroughly evaluated. If the registration is not rejected, then the existing substances can continue to be marketed as before.
The first registration deadline of 1 December 2010 saw the registration of phase-in substances that are marketed at high volume (manufactured or imported at >1000 t/a), those that are carcinogenic, mutagenic, or reprotoxic (CMRs) marketed at >1 tonne, and substances currently classified both as very toxic to aquatic organisms and persistent in the environment marketed at >100 tonne. During the period to June 2013, the Commission will require the registration of substances marketed at 100 to 1000 t/a. Finally, in years 6 to 11 (deadline June 2018), substances marketed in lower amounts (1 to 100 t/a) will be registered. The Commission reason that this tiered approach will prioritise the evaluation of phase-in substances of highest concern, ie HPVs, CMRs, PBTs, and vPvBs.
Click on this link to download a REACH Registration Timetable.
Evaluation
Evaluation is seen as a two-step procedure:
Administrative: the Agency evaluates the substance dossier, with regard to both the testing proposals, particularly the impact on animal welfare, and compliance with the regulatory requirements for registration.
Technical: the Agency evaluates the substance itself for risks to human health or the environment. The Agency can ask for further information if there is insufficient to determine whether the substance will be used safely.
Authorisation
The Commission will issue a specific authorisation for the use of substances with properties of very high concern. These are:
Category 1 and 2 CMRs
PBTs
vPvBs
Other substances identified as having serious and irreversible effects to humans or the environment (eg endocrine disruptors)
The authorisation is envisaged as a two-step procedure:
Administrative: the Agency decides which substances, and also which uses, will require authorisation. The Agency will be prioritise the substances and set deadlines for the provision of information by industry.
Technical: The applicant will have to demonstrate that such substances are adequately controlled through risk management. The Agency will provide an expert opinion on the substance, and grant an authorisation if this if favourable.
Restriction
Where manufacturers or importers do not demonstrate adequate control of the risks from hazardous chemical products, then the Commission may impose restrictions, including bans, on the marketing or use of such products. The restrictions procedure thus acts as a safety net.
The current restrictions are set out in REACH Annex XVII.
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