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REACH

Registration, Evaluation, and Authorisation of Chemicals (REACH)

Services

REACH consultancy

• Alchemy Compliance can advise on all aspects of the REACH legislation.

• Broad experience in chemical supply legislation (notification, classification, risk assessment, etc.), and regulatory chemistry, toxicology, and ecotoxicology.

• REACHReady Service Provider (UK Chemical Industries Association approved)

Fulfilling data requirements

• Product evaluation and gap analysis.

• Literature and inventory searching for hazard information on chemical substances (physico-chemical, toxicological, ecotoxicological); assignment of reliability codes to literature data.

• Application of structure–activity relationships and computer modeling to chemicals as a substitute for test data.

• Read-across and ‘grouping’ (category formation) of chemicals according to structure and properties to minimize overall testing.

• Expert reports for ‘data waiving’ arguments.

• Advice on testing strategies, tests (including ‘alternative tests’) and laboratories.

Hazard and risk assessment

• Calculation of human and environmental exposures during the lifecycle of the substance (industrial, professional, and consumer use), including use of EUSES software; development of exposure scenarios.

• Assessment of likelihood of substances fulfilling the criteria for toxic, persistent and bioaccumulation (PBT), and very toxic, very bioaccumulative (vPvB).

• Interpretation of physico-chemical, toxicological and ecotoxicological data.

• Classification according to current EU criteria and the globally harmonized system (GHS).

• Risk assessment, including chemical safety assessments and preparation of chemical safety reports.

Administrative

• Compilation of ‘robust summaries.’

• Dossier preparation in electronic format (eg IUCLID).

• Assistance with consortia formation to supply a single registration dossier; data management for consortia.

• Safety data sheet authoring (EU, US, Australia), including REACH extended SDSs.

• Assistance with compilation of company inventory of substances, along with annual volumes, to determine responsibilities under REACH.

Legal representation in Europe

• Alchemy Compliance can act as your legal representative within Europe (‘only representative’), maintaining a reliable and confidential service.

Training

Alchemy Compliance is able to equip companies by providing training for chemical compliance issues, such as REACH, GHS, safety data sheet preparation, and risk assessment.

Further information

Registration, Evaluation, and Authorisation of Chemicals (REACH)

What improvements will REACH achieve?

The stated aims of the proposed REACH 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 through testing of thousands of older industrial chemicals, bringing to an end the previous distinction between ‘existing’ and ‘new’ chemical substances. The product stewardship and public knowledge of chemical products will be greatly improved. 

What will industry be required to do?

1.1 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 (see Annex III of REACH Proposal):

• ‘As registered’ products: notified new chemicals (until next tonnage threshold is reached); biocide, pesticide, medicinal active ingredients, etc., that are regulated under separate legislation.

• Low risk substances (eg some natural oils, fatty acids, glycerides; 68 substances in total; see Annex IV of REACH Common Position)

• By-products, impurities, or degradation products (Annex V)

• Non-dangerous natural products (Annex V)

• Elemental substances with well known risk (Annex V)

• Polymers (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)

1.1.1 Technical dossier

The technical dossier contains the following information on the substance (see Article 10 of REACH Common Position):

• 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 of the Common Position. The information requirements depend on the marketing tonnage.

• Other information already available.

1.1.2 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)

• Assessment of the substance as very persistent and very bioaccumulative (vPvB)

• Exposure scenarios for PBT and vPvB substances, including risk assessment measures, for the lifecycle of the substance, for all ‘identified uses’.

1.1.3 Registration timetable (click on the image to enlarge)

Manufacturers and importers are expected to register ca. 30 000 ‘phase-in’ substances (those on the EU market for >15 years) during the first 11 years of REACH. The Agency will perform only a simple completeness check (see Section on Evaluation), 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, and ‘none-phase in’ substances can begin to be marketed. Notification under the Dangerous Substances Directive (67/548/EEC, as amended) are considered as having been registered, although the registration may need updating when a higher tonnage threshold is reached.

The first three years of REACH will see the registration of high production volume substances (HPVs), manufactured or imported at >1000 t/a, those that are carcinogenic, mutagenic, or reprotoxic (CMRs) at >1 tonne, and substances currently classified both as very toxic to aquatic organisms and persistent in the environment at >100 tonne. The subsequent three years will require the registration of substances marketed at 100 to 1000 t/a. Finally, in years 6 to 11, 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 substances of highest concern, ie HPVs, CMRs, PBTs, and vPvBs.

1.2 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.

1.3 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.

1.4 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.
As an example, the current restrictions set out in 76/769/EEC (eg on asbestos, certain azo-dyes) will be carried forward in REACH.

Other features

1.5 Classification and labelling inventory

A centralised inventory will aid harmonisation of the classification of chemical substances.
Industry will be required to submit all substance classifications to the Agency for inclusion into the inventory within 3 years of the entry into force of the REACH regulation. The Commission expects that differences in classification will be resolved by industry, while there will be mandatory, harmonised classifications for substances that are CMRs (Cat. 1, 2, and 3), or respiratory sensitisers.

1.6 Public access to information

The Commission aims to publish on the internet the results of physico-chemical, toxicological, and ecotoxicological testing, to allow the interested parties to assess the risk of exposure to specific chemicals. Industry can maintain some information as confidential, while other information will be available to the public only on specific request.

1.7 Costs

The REACH Impact Assessment concluded that the direct costs of REACH to the chemical industry would be ca. €2.3 billion for the first 11 years. The overall costs are estimated at €2.8 billion to 5.2 billion. The number of substances withdrawn because of costs is expected to be 1 to 2%.

What should industry do now?

The following actions should be taken in preparation for the publication of the REACH legislation (expected 2007):

• Examine all company products and formulations, both manufactured and purchased, and list all the substances contained therein, along with annual volumes. For polymers, the monomers should be taken into consideration.

• Set up a company inventory of manufactured or imported (from outside the EU) substances, along with annual volumes. These are the substances for which you will be responsible for registration.
• Identify the CAS number and any available hazard information on these substances (eg proprietary, literature, SAR).
• Identify your customers within the EU to whom the substance, whether formulated or not, is supplied.
• Compile readily available information on human and environmental exposures during the lifecycle of the substance (industrial, professional, and consumer use).
• Look for other manufacturer/importers of the same substance with a view to consortia formation to supply a single registration dossier.

• Set up a company inventory of substances purchased from within the EU, along with annual volumes. These are the substances for which you are a ‘downstream user (DU).’

• Identify supplier of all substances for which you are a DU.

Dialogue with suppliers for re-assurance that key substances will be supported through registration process, and whether the use pattern of the substance in your company is likely to be covered in the registration.

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