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Our Silver and Gold subscribers have to access a comprehensive list of Frequently Asked Questions on the password-protected section of our website. There you can access detailed information on each of REACH’s important stages, when they have to be complied with, and we fully explain what is really meant by a transported isolated intermediate! We also give advice on what downstream users of chemicals are required to do under REACH – and much more besides.
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| Here’s just a taster of the information that's available and if you like what you see, "Join for free" to get instant access to our full FAQ... |
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| Where can I find the current REACH legislative text and Technical Guidance Documents? |
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You can find the legislative text here. Updates to the Annexes IV, V, XVII are also available:
Annex IV, V
Annex XI
Annex XVII .
These documents form the main REACH legal text, and differ to the previous versions of REACH.
Our Gold subscribers can download the full set of REACH technical guidance documents from the "Technical Downloads" section of our website. Exclusively for our Gold customers, REACHReady is developing a set of guidance documents to help understand the intricacies of REACH – click "join for free" to access them!
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| What is a substance ? |
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| The term “substance” refers to all chemicals, including metals. REACH applies to substances in mixtures, as well as certain substances contained in articles. |
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| Why has a new EU chemicals strategy been developed? |
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| The pre-REACH EU legislation for chemical substances was a patchwork of many different Directives and Regulations which have developed since 1967 when the first Dangerous Substances Directive was introduced. There were different rules for “existing” and “new” substances (all substances that were put on the market before 1981 are called "existing" substances). This system did not produced sufficient information about the effects of the majority of existing substances on human health and the environment. |
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| The identification and assessment of risks – in other words the substance’s hazard combined with the exposure of humans and the environment to it – proved to be slow, as were the subsequent introduction of risk management measures. The pre-REACH system, in particular for new substances , is believed by some to have hampered research and innovation causing the EU chemicals industry to lag behind its counterparts in the US and Japan. |
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| The pre-REACH EU distinction between so-called "existing" and "new" substances is based on the somewhat arbitrary cut-off date of 1981. In 1981, they numbered 100,106 different substances (listed on EINECS – the European Inventory of Existing Chemical Substances). Substances introduced to the market after 1981 (about 3,000) are termed "new" substances . |
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| While new substances had to be tested extensively (and expensively) before they are placed on the market, there were no such provisions for "existing" substances. As a result, although some information exists on the properties and uses of existing substances, there is a lack of sufficient information publicly available to assess and control these substances effectively. |
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| Before REACH, the allocation of responsibilities was also considered by many EU Member States, the European Commission and others, to be inappropriate: public authorities were responsible for undertaking risk assessments of substances rather than the enterprises that manufacture, import or use them. Since 1993, 141 (out of the 100,106) existing substances have been identified for risk assessment and possible recommendations for risk reduction. Although draft risk assessments are now available for most of these, only a limited number (approximately 30) have gone through the entire process. |
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| On the other hand, all “new” substances had to be notified and tested starting from volumes as low as 10 kg per year and risk assessments prepared. This obligation has resulted in extensive knowledge about the hazards and risks of new substances . However, some have questioned the disproportionate amount of effort that has been put – by both industry and the authorities – in regulating new chemicals given that they account for only around 1% of the total tonnage of chemicals currently on the EU market. |
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| In addition, pre-REACH legislation required the manufacturers and importers of chemicals to provide certain information, but did not impose similar obligations on downstream users (industrial users and formulators) unless the substance had to be classified and a safety data sheet had to be supplied with it further down the supply chain. As a result, information on uses of substances could be difficult to obtain and information about the exposure arising from downstream uses scarce. |
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| If EU-wide controls (e.g. bans and restrictions) were considered to be necessary, the pre-REACH legislation allowed restrictions on the marketing and use of substances to be introduced. The introduction of restrictions started in 1976 (Directive 76/769/EEC) and restricted the marketing or use of about 100 substances, including the use of some of them in articles. Restrictions on the marketing to the general public of about 900 substances classified as carcinogenic, mutagenic or toxic to reproduction was also included under the Directive. |
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| What are the objectives of REACH? |
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| The two most important aims are to improve protection of human health and the environment from the risks of chemicals and to maintain the competitiveness of EU industry. |
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| In the White Paper on the "Strategy for a future Chemicals Policy", published in February 2001 (COM (2001) 88), the Commission outlined the result of a review of the current system and its new strategy for ensuring a high level of chemicals safety and a competitive chemicals industry through a system for the Registration, Evaluation and Authorisation of Chemicals – the REACH system – operated by a new European Chemicals Agency, in conjunction with Member State regulatory authorities and the European Commission. |
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| The White Paper identified seven objectives, subsequently endorsed by the European Council of Ministers and the European Parliament, that needed to be balanced within the overall framework of sustainable development: |
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Protection of human health and the environment |
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Maintenance and enhancement of the competitiveness of the EU chemical industry |
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Prevention of fragmentation of the internal market |
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Increased transparency |
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Integration with international efforts |
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Promotion of non-animal testing |
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Conformity with EU international obligations under the World Trade Organisation (WTO). |
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| The challenge for all those involved in formulating and developing REACH has been to achieve the right balance between these potentially competing objectives. |
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| How has the REACH legislation changed since it was first proposed in October 2003? |
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| Compared to the European Commission proposal, the key points of the Council agreement are as follows: |
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Reduced information requirements for 1-10 tonne substances, except for substances meeting certain criteria identifying them as potentially risky (e.g. classified as dangerous and having a wide dispersive use in consumer applications) |
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Increased scope for waiving of tests for 10-100 tonne substances where exposure to humans and the environment is minimal. |
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Requirement for registrants of the same substance to share core data and work together through ‘one substance , one registration’ |
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Exemption of certain low-risk substances (such as cellulose pulp) from registration |
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Requirement for a downstream user to perform a Chemical Safety Assessment limited to substances it uses above 1 tonne per annum |
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Registration of substances intended to be released from articles when present above 1 tonne following the same timeline as the registration of substances on their own and in mixtures (for example, paint). Importers of articles otherwise need only to notify the authorities if the article contains a substance of very high concern |
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Strengthening of the provisions for substituting the most dangerous substances subject to authorisation, for instance by ensuring that all authorisations are reviewed. |
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| More detailed summaries of the changes can be found under the relevant parts of the REACH process below. |
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| How is the REACH legislation organised? |
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| The REACH legislative text is organised into fifteen Titles. The first eight Titles refer to registration, evaluation, authorisation and restriction processes. The remaining seven Titles detail the administrative elements of REACH, such as the establishment of a European Chemicals Agency, confidentiality of data, and enforcement issues. A number of Annexes detail the technical obligations. Technical Guidance Documents supplement the text and Annexes. |
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| How will the REACH process work? |
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| In brief, manufacturers or importers of all substances within scope manufactured in, or imported into, the EU in quantities of 1 tonne or more per year will need to submit a registration to the European Chemicals Agency (the Agency). |
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| For existing (phase-in) substances deadlines apply largely on the basis of tonnage. The Agency will manage a database, which will contain the registration dossiers and other information generated by REACH and co-ordinate the implementation of REACH. |
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| Once a substance is registered, the Agency will perform a completeness check of the registration dossier. The Agency will perform a quality evaluation for a minimum percentage of dossiers (currently 5% of them). All proposals for testing will be evaluated. The Agency, in conjunction with Competent Authorities located in the Member States, may perform substance evaluations (as opposed to evaluations of dossiers) if the substance is considered to be of potential concern. |
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| Substances that are identified as being of very high concern to human health or the environment will be subject to authorisation. The restriction process allows EU-wide control of substances identified as causing a risk to human health or the environment. |
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| Which substances are within the scope of REACH and which are exempt? |
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| Substances manufactured in, or imported into, the EEA will be subject to REACH, unless otherwise exempt. Some obligations (i.e. those relating to Safety Data Sheets) also apply to mixtures themselves. |
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| Updated! A number of substances are exempt from various stages of the REACH process because the risk is expected to be low and/or registration would be a disproportionate requirement. The precise definitions and conditions for each exemption are detailed in the legislation, in particular in Article 2 and Annexes IV and V (see the REACH Regulation text and the updated Annexes IV and V. Warning: these files are very large pdfs!). For instance, some exemptions apply to registration but not to the authorisation process. |
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| Our free REACHScope tool can help here, available to all our subscribers. |
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| What are substances of very high concern (SVHCs)? |
Substances of very high concern (SVHCs)
are substances identified as having hazardous properties of particular and very high concern. They must be regulated because the effects they can have on humans and the environment are very serious and often irreversible.
SVHCs include substances which are:
- Carcinogenic, Mutagenic or toxic to Reproduction (CMR) classified in category 1 or 2,
- Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation, and/or
- identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to humans or the environment of an equivalent level of concern as those above e.g. endocrine disrupters.
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| What is the Candidate List? |
The Candidate List is a list of substances of very high concern (SVHCs) identified as potential targets to be strictly regulated for use within the EEA by the process of authorisation (the "A" of REACH). A substance included on the Candidate List may be added to Annex XIV of REACH
– the list of authorised substances
– which would mean companies using that substance in the EEA must be authorised by the regulators for their particular use (unless the use is exempt from the authorisation process).
The Candidate List is published on the ECHA website at http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp
Publication of the Candidate List triggers immediate legal obligations for many companies within the EEA; the list is expected to be updated twice per year. |
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| Who does REACH apply to? |
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| Any company producing, importing, using or placing a substance , mixture or article on the EU market will be responsible for ensuring that it is in compliance with REACH. The legislation therefore covers EU-manufacturers, including chemical suppliers , distributors and downstream users , as well as EU enterprises importing products to the European Community market. |
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| A non-EU manufacturer has the option of appointing an "only representative" to meet the registration requirements of REACH on its behalf for all its EU importers of the substance in question. If this option is not taken each importer will have to comply with REACH independently (“one substance one registration” and data sharing requirements notwithstanding). Similarly, a group of companies in a Substance Information Exchange Forum may appoint a leader for the purposes of registration, possibly a third party, to organise and co-ordinate the registration process. The Council text further clarifies that a manufacturer, importer , or downstream user can use representatives when participating in a Substance Information Exchange Forum. |
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| REACH is a complicated piece of legislation. What help will be given to stakeholders in implementing its requirements? |
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The European Commission, as part of its preparations for REACH, carried out seven REACH Implementation Projects (RIPs). Once finalised, official Guidance Documents were published by the ECHA to assist both industry and the authorities.
The Guidance Documents are available as technical downloads for our subscribers. Further information and the Guidance Documents can also be found on the Agency's website. |
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| Even with these projects in place there remains a degree of complexity with REACH implementation – no need to worry though, REACHReady will be able to help you! |
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| How can companies prepare for REACH? |
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| How a company prepares for REACH will depend on its commercial activities. Examples of preparatory activities that companies are currently taking include: |
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Setting-up administrative and product management systems to facilitate complying with REACH when it enters into force |
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Developing portfolios of substances affected by REACH and identifying gaps in the information currently available and that likely to be needed |
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Reviewing and improving available data (e.g. contained in Safety Data Sheets) |
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Communicating the potential business impact of REACH with suppliers and customers. |
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| REACHReady is able to advise companies on what they should be doing now to prepare for REACH. We can also direct you to those best placed to offer specific help and advice in the form of consultancy through our REACHMatchmaker programme. |
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| Has this whetted your appetite? |
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| Our subscribers have to access an enhanced version of this FAQ. We’ve added sections on each of REACH’s important stages, when they have to be complied with, and explain what is really meant by a transported isolated intermediate!! We also give advice on what downstream users of chemicals are required to do under REACH – and much more besides. "Join for free" to get instant access. |
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