Chemicals covered by REACH
Chemicals covered by REACH
The REACH proposal contains rules about chemical substances on their own, in preparations and in articles. It aims at controlling risks from both the so-called “existing” substances (put on the European market before 1981) and the so-called “new” substances (introduced after 1981). Around 30 000 marketed substances will need to be registered under REACH. Up to 1 500 substances of very high concern will be subject to authorisation.
Some chemicals present in workplaces are not included in REACH, for instance, non-isolated intermediates, e.g. substances solely manufactured for chemical synthesis of other substances and never separated from the reactional mixture. For other chemicals (polymers, substances used for research and development), complete or partial exemptions are planned. Finally, REACH has been designed to complement but not overlap with other EU legislation. It will not apply to other cases considered to be addressed by equivalent Community legislation.
Scope
REACH lays down provisions which shall apply to the manufacture, import, placing on the market or use of substances on their own, in preparations or in articles.
REACH provides information on substances that will support the operation of worker protection and transport legislation, which operate unchanged.
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Radioactive substances, within the scope of Council Directive 96/29/Euratom(1), are excluded from the scope because they are addressed by other legislation.
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Substances under customs supervision which are in temporary storage, in free zones or free warehouses with a view to re-exportation or in transit are not used within the meaning of REACH and so are also excluded.
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Non-isolated intermediates are not within the scope.
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The coverage of other chemicals by REACH is given in table below:
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R E A C H |
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Registration of substances |
Substance evaluation and |
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There is a general obligation to register substances manufactured or imported in quantities starting at 1 tonne per year. Failure to register means that the substance cannot be manufactured or imported. |
Under REACH, risks for human health associated with uses of substances with properties of very high concern will be reviewed and, if they are adequately controlled, or if the socio-economic benefits outweigh the risks and there are no suitable alternative substitute substances or technologies, then the uses will be granted an authorisation. |
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substances in medicinal products for human or veterinary use |
exempted |
exempted |
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substances used as food additives in foodstuffs |
exempted |
exempted |
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substances used as flavourings in foodstuffs |
exempted |
exempted |
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substances in animal nutrition |
exempted |
exempted |
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substances used for plant protection products or biocides |
exempted |
exempted |
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dangerous substances in articles, intended to be released |
yes |
yes |
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dangerous substances in articles, whose release is not intended |
notification, registration on request from the Agency |
yes |
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dangerous substances in articles, but not released |
no |
no |
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substances whose risks are considered to be adequately well known such as Vitamin A for instance (REACH, annex II) |
exempted |
yes |
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substances whose risks are already addressed through the assessment of other registered substances (REACH, annex III) such as for instance, hydrates of a substance or hydrated ions, formed by association of a substance with water |
exempted |
yes |
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registered substances which have been exported from the Community and which are subsequently re-imported |
exempted |
yes |
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exempted |
yes |
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yes, limited requested information |
exempted |
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substances used in scientific research and development (<1T/year) |
no |
exempted |
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substances used in product and process orientated research and development |
exempted five years, extended for up to a further 5 years (development of medicinal products, extented for up to a further 10 years) |
exempted if < 1 T/year |
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substances which are waste and are treated in a waste treatment installation |
yes |
exempted |
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substances used in cosmetic products |
yes |
exempted |
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substances used in food contact materials |
yes |
exempted |
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substances used as fuels |
yes |
exempted |
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substances present in preparations below some concentration limits considered as not giving rise to concern |
yes |
exempted |
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other substances |
yes |
yes |
(1) Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation. OJ L159, 29.6.1996, p. 1.
The 5 above headings detail the rules specific to the different chemicals categories.
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Substances and preparations
Substance means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
Preparation means a mixture or solution composed of two or more substances.
REACH regulation lays down provisions on substances on their own or in preparations:
General obligation to register
Save where this regulation provides otherwise, any manufacturer or importer of a substance, either on its own or in a preparation, in quantities of 1 tonne or more per year shall submit a registration to the Agency. It is the substances in the preparations that need to be registered, not the preparations themselves.
Chemical safety report
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A chemical safety assessment shall be performed and a chemical safety report completed for all substances subject to registration if the registrant manufactures or imports such a substance in quantities of 10 tonnes or more per year.
This assessment doe not need to be performed for substances in preparations in certain very small concentrations i.e. less than the lowest of any of the following:
(a) applicable concentrations defined in the table of Article 3(3) of Directive 1999/45/EC(1);
(b) concentration limits given in Annex I to Directive 67/548/EEC(2);
(c) concentration limits given in Part B of Annex II to Directive 1999/45/EC;
(d) concentration limits given in Part B of Annex III to Directive 1999/45/EC;
(e) concentration limits given in the classification and labelling inventory established under REACH Title X;
(f) 0.1%, if the substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative (REACH, Annex XII).
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These concentrations are considered as not giving rise to concern and substances in preparations in such low concentrations are also exempt from authorisation.
Safety data sheet
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Where a substance or preparation meets the criteria for classification as dangerous, the person responsible for placing that substance or preparation on the market, shall supply the recipient, who is a downstream user or distributor, with a safety data sheet (SDS).
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To prepare an safety data sheet for a preparation containing many registered substances could be a complicated exercise. The option is therefore open for those preparing SDS for a preparation to carry out a chemical safety assessment (CSA) for the preparation as a whole (REACH, annex I ter) and for the SDS to reflect this CSA rather than the individual CSAs for all registered components of the preparation.
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Where a preparation does not meet the criteria for classification as dangerous but contains in an individual concentration, 1 % or more by weight for non-gaseous preparations and 0.2 % or more by volume for gaseous preparations, of at least one substance posing health or environmental hazards, or one substance for which there are workplace exposure limits, the person who is responsible for placing that preparation on the market, whether the manufacturer, importer, downstream user or distributor, shall supply, at the request of a downstream user, a safety data sheet.
(2) Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. OJ 196, 16.8.1967, p. 1. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).
Intermediates
Intermediates are substances solely manufactured for chemical synthesis of other substances.
Non-isolated intermediates – never separated from the reactional mixture - are excluded from REACH. The isolated intermediates do have to be registered but most often with limited information requirements. A distinction is made between isolated intermediates that remain on site, and those that are transported to other sites.
On-site isolated intermediates
Any manufacturer of an on-site isolated intermediate in quantities of 1 tonne or more per year shall submit a registration to the Agency. It shall include all the following information, to the extent that the manufacturer is able to submit it without any additional testing:
(a) the identity of the manufacturer (REACH, annex IV, section1);
(b) the identity of the intermediate (REACH, annex IV, section 2);
(c) the classification of the intermediate;
(d) any available existing information on physicochemical, human health or environmental properties of the intermediate.
For on-site isolated intermediates, neither dossier nor substance evaluation shall apply. However, Member States may ask for additional information and take necessary action on such a substance if they can demonstrate that its use gives rise to a risk equivalent to the level of concern arising from the use of substances subject to authorisation.
Transported isolated intermediates
Any manufacturer or importer of a transported isolated intermediate in quantities of 1 tonne or more per year shall submit a registration to the Agency. It shall include as for an on-site isolated intermediate:
(a) the identity of the manufacturer or importer;
(b) the identity of the intermediate;
(c) the classification of the intermediate;
(d) any available existing information on physicochemical, human health or environmental properties of the intermediate.
However, where more than 1000 tonnes per manufacturer per year are transported, more data is required (REACH, annex V) as the risk of exposure is potentially higher.
All these clauses above shall apply only to transported isolated intermediates the transport of which to other sites and toll or contract manufacture, (where the synthesis of (an)other substance(s) from that intermediate takes place on those other sites) are under strictly controlled conditions.
If these conditions are not fulfilled, the registration shall include the information required for any other substance.
Note : Chemical safety assessments and chemical safety reports are not required for on-site isolated intermediates, or transported isolated intermediates.
Monomers
Monomers have to be registered as any other substance, even if they are used as intermediates, and the lighter rules on intermediates do not apply to them. This is necessary because the polymers resulting from their use as intermediates are not subject to registration.
Polymers
Polymers are substances whose structure results mainly from the repetition of low molar mass units (monomers). Plastics are examples of polymers.
In view of the potentially large number of polymer registrations and given that most of them pose a limited risk because of their nature, polymers are exempted from registration and evaluation for reasons of workability, and to focus resources on substances of more concern. However, they may still be subject to authorisation and restriction. The Commission is committed to considering how polymers should be addressed in REACH in the future.
Monomers used as on-site isolated intermediates or transported isolated intermediates, have to be registered as any other substance and the lighter rules on intermediates do not apply to them. This is necessary because the polymers resulting from their use are not subject to registration.
Any manufacturer or importer of a polymer shall submit a registration to the Agency for the non-registered monomer substance(s) or other non-registered substance(s) if both the following conditions are met:
(a) the polymer consists of 2% weight by weight (w/w) or more of such monomer substance(s) or other substance(s);
(b) the total quantity of such monomer substance(s) or other substance(s) makes up 1 tonne or more per year.
Substances in articles
Most articles contain chemicals. Some of these are potentially hazardous to environment and health, if they are released.
Under REACH, those substances that are intended to be released as part of the utility of the article (e.g. a ink in a cartridge) need to be registered if they are classified as dangerous. The same information requirements as for other substances apply. Therefore, any producer or importer of articles shall submit a registration to the Agency for any substance contained in those articles, if all the following conditions are met:
(a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year, each article type being considered separately;
(b) the substance meets the criteria for classification as dangerous;
(c) the substance is intended to be released under normal and reasonably foreseeable conditions of use.
This paragraph shall not apply to substances that have already been registered for that use by an actor up the supply chain
If the release of hazardous substances is not intended as part of the functioning of an article, but happens anyway (e.g. formaldehyde released from fibreboard), the substances have to be notified to the Agency, who will decide whether a registration is needed. Therefore, any producer or importer of articles shall notify the Agency of any substance contained in those articles, if all the following conditions are met:
(a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year;
(b) the substance meets the criteria for classification as dangerous;
(c) the producer or importer knows, or it is made known to the producer or importer, that the substance is likely to be released under normal and reasonably foreseeable conditions of use, even though this release is not an intended function of the article;
(d) the quantity of the substance released may adversely affect human health or the environment.
If these conditions are met, the information to be notified shall include the following:
(a) the identity and contact details of the producer or importer;
(b) the registration number(s), if available;
(c) the identity of the substance(s) (REACH, annex IV, section 2);
(d) the classification of the substance;
(e) a brief description of the use(s) of the article;
(f) the tonnage range of the substance, such as 1-10 tonnes, 10-100 tonnes and so on.
These paragraphs shall not apply to substances that have already been registered for that use by an actor up the supply chain.
The Agency shall be able to require the producers and importers concerned, to register such notified substances.
It should be noted that no declaration of contents in articles is required from importers.
Substances used in R & D
To support industry’s competitiveness, one of the objectives of REACH is to promote research and development (R & D) and innovation. This results in a number of exemptions.
Registration
Substances used for product and process orientated research and development (PPORD) are exempted from registration. This exemption shall be for up to 5 years and apply to the quantity of substance being used for PPORD and a limited number of listed customers.
The manufacturer or importer shall notify the Agency of the following information:
(a) the identity of the manufacturer or importer;
(b) the identity of the substance;
(c) the classification of the substance, if any;
(d) the estimated quantity;
(e) the list of customers and
(f) sufficient information on the research and development programme to enable the Agency to take informed decisions.
The five years period shall begin at receipt of the notification at the Agency. The Agency shall check the completeness of the information supplied by the notifier. It may decide to impose conditions with the aim of ensuring that the substance or the preparation or article in which the substance is incorporated will be handled only by staff of listed customers in reasonably controlled conditions and will not be made available to the general public at any time either on its own or in a preparation or article and that remaining quantities will be re-collected for disposal after the exemption period. The exemption period may be extended by the Agency for up to a further 5 years upon application as long as this can be justified by the programme of research and development. In the case of development of medicinal products for human or veterinary use, extension is possible for up to 10 years. Competent Authorities in Member States in which the manufacture, import or PPORD takes place shall be provided with all information submitted in notifying a request for a PPORD exemption. The Agency shall take into account the views of the Competent Authorities concerned when making decisions on PPORD exemptions or extensions.
Scientific research and development normally takes place in quantities below 1 tonne per year, there is no need to exempt such research and development because substances in those quantities do not have to be registered in any case.
Authorisations
The authorisation process shall not apply to substances being used solely for scientific research and development purposes or for product and process-orientated research and development purposes in quantities under 1 tonne.
Restrictions
The restrictions in Annex XVI of REACH regulation (restrictions on the manufacture, placing on the market and use of certain dangerous substances, preparations and articles) do not apply to substances being used for scientific research and development purposes and for product and process orientated research and development, if these substances are used in amounts of less than 1 tonne.
The restrictions in Annex XVII (persistent organic pollutants) do not apply to substances being used for laboratory scale research or as a reference standard. Thereby the exemption is tighter than the one applying to substances included in Annex XVI.
Appeals
Appeals can be brought against decisions taken: to grant, reject or place conditions on an application for a PPORD exemption.
Any decision being appealed against shall not apply until the appeal is considered.