Where can I find the current REACH legislative texts, and guidance to help me understand what I need to do?

You can find the legislative text here. The latest updates to a number of the Annexes are also available:

• Annex II (Safety Data Sheets):
  Regulation (EU) No 453/2010

• Annexes IV and V (registration exemptions):
  Regulation (EC) No 987/2008

• Annex XI (adaptation of standard testing):
  Regulation (EC) No 134/2009

• Annex XIII (PBT and vPvB criteria):
  Regulation (EU) No 253/2011
  

• Annex XIV (the Authorisation list):
  Regulation (EU) No 143/2011and its Corrigendum
  Regulation (EU) No 125/2012

• Annex XVII (Restriction):
  Regulation (EC) No 552/2009
  Regulation (EU) No 276/2010 (Dichloromethane, lamp oils and grill lighter fluids and organostannic compounds)
  Regulation (EU) No 207/2011 (Diphenylether, pentabromo derivative and PFOS)
  Regulation (EU) No 366/2011 (Acrylamide)
  Regulation (EU) No 494/2011 (Cadmium) and its Corrigendum
  Regulation 109/2012 (CMRs)

These documents form the main REACH legal text, and differ to the previous versions of REACH.

Exclusively for our Gold customers, REACHReady is has a comprehensive set of guidance documents to help understand the intricacies of REACH – click "join for free" to access them!

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What is the aim of REACH?

REACH aims to improve protection of human health and the environment from the risks of chemicals, whilst maintaining the competitiveness of the EU chemical industry.

In the White Paper on the “Strategy for a future Chemicals Policy”, published in February 2001 (COM (2001) 88), the Commission outlined its intentions for a new strategy for ensuring a high level of chemicals safety and a competitive chemicals industry through the Registration, Evaluation and Authorisation of Chemicals – the REACH system – operated by a new European Chemicals Agency (ECHA), in conjunction with Member State regulatory authorities and the European Commission.

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:

• Protection of human health and the environment
• Maintenance and enhancement of the competitiveness of the EU chemical 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 World Trade Organisation (WTO).

The challenge for all those involved in developing REACH has been to achieve the right balance between these potentially competing objectives.

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Why was a new EU chemicals strategy developed?

The pre-REACH EU legislation for chemical substances is 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. The former EU legislation regime also concentrated on hazards, with the end point being classification, with considerably less emphasis on risk.

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 old system, in particular for new substances, was believed by some to have hampered research and innovation causing the EU chemicals industry to lag behind its counterparts in the US and Japan.

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 .

While new substances had to be tested extensively (and expensively) before they were 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.

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 had 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) had gone through the entire process.

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.

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.

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 were also included under the Directive.

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How does the REACH process work?

In brief, manufacturers or importers of all substances within scope manufactured in, or imported into, the EEA (EU plus Norway, Iceland, Liechtenstein) in quantities of 1 tonne or more per year need to submit a registration to the European Chemicals Agency, ECHA.

For existing (phase-in) substances registration follows deadlines set largely on the basis of tonnage. ECHA manages the REACH-IT web portal and database, which holds the dossiers submitted by companies as well as other information generated by REACH, and also coordinates the implementation of REACH.

Once a substance registration dossier is submitted through REACH-IT, ECHA performs a completeness check of the registration dossier to ensure both the registration fee has been paid and that all the required pieces of information have been included in the IUCLID5 dossier. ECHA will also perform a quality evaluation for a minimum percentage of 5% of dossiers submitted. All proposals for testing will be evaluated. ECHA, in conjunction with Competent Authorities located in the Member States, may perform more detailed substance evaluations (as opposed to evaluations of dossiers) if the substance is considered to be of potential concern.

Substances that are identified as being of very high concern to human health or the environment may be subject to authorisation. This control process allows EEA-wide control of substances identified as causing a risk to human health or the environment.

REACH is a complicated piece of legislation. What help is given to stakeholders in implementing its requirements?

The European Commission, as part of its preparations for REACH, carried out six REACH Implementation Projects (RIPs) to enable a smooth transition from existing chemical legislation to REACH.

Further information on the tools and methodologies used for REACH can be found on the website of the former European Chemicals Bureau, and the official guidance documents on the ECHA website.

Even with these projects in place there remains a degree of complexity with REACH implementation – REACHReady can help you through our subscriptions, training courses and consultancy services and our free Matchmaker programme!

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Who does REACH apply to?

Any company producing, importing, using or placing a substance, mixture or article on the EEA market will be responsible for ensuring that it is in compliance with REACH. The legislation therefore covers EEA manufacturers, including chemical suppliers, distributors and downstream users, as well as EEA enterprises importing products to the European Community market.

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 (SIEF).

If you export chemicals or articles into the EU from elsewhere in the world you may be interested in our "REACH Basics Summary for non-EU companies".

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Which substances are within the scope of REACH and which are exempt?

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. .

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 large pdfs!). For instance, some exemptions apply to registration but not to the authorisation process.

Our free REACHScope tool can help, available to all our subscribers.

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What is a substance?

The term “substance” refers to all chemical elements and compounds, including metals. REACH applies to substances in mixtures, as well as certain substances contained in articles.

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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 and have therefore been included on the Candidate List. 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 1A or 1B,
• 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 disruptors.

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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 EU and EEA Member States 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 substances subject to authorisation – which would mean the use must be authorised by the regulators (unless the use is exempt from the authorisation process).

The Candidate List is published on the ECHA website at http://echa.europa.eu/web/guest/candidate-list-table

Publication of the Candidate List triggers obligations for many companies within the EEA; the list is usually updated twice a year. To see how your business might be affected why not join for free today to get access  our guidance on common uses ofthe Candidate List substances?

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I am a supplier of finished goods based in the EU. My products contain substances on the Candidate List. What are my obligations?

Companies in the EU or EEA Member States who supply finished goods (known as "articles" in REACH) containing Candidate List substances present above 0.1% w/w have communication obligations under Article 33 of the regulation. You must give the recipient of the article sufficient information to allow safe use of the item, as a minimum the name of that Candidate List substance. You are also obliged to give the same information upon request to a consumer within 45 days of receipt of the request.

In addition, any importer or producer of articles may be required to notify the European Chemicals Agency, ECHA, if a Candidate List substance is present in the articles above 0.1% w/w and the quantity of the substance totals above 1 tonne per year. The duty to notify began in June 2011.

There is a summary of the Candidate List obligations on the ECHA website at http://echa.europa.eu/candidate-list-obligations

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What is Annex XIV of REACH ?

Annex XIV of REACH is the list of substances subject to Authorisation. They are chosen because of their particularly hazardous properties and are selected from the Candidate List of substances. Substances included in Annex XIV are tightly regulated such that their specific use must be authorised, in order to minimise exposure to humans or the environment. After the "sunset date" listed in Annex XIV, companies in the EEA must not use a listed substance without specific authorisation to do so (unless the use is exempt).

Annex XIV of REACH was first populated with six substances in February 2011; a further eight substances were added in February 2012.

If you manufacture, import or use substances in Annex XIV then REACHReady can advise on the timescales involved in the authorisation process and on your options. And if your company uses SVHCs that are candidates for inclusion in Annex XIV we can help you work out your strategy. Contact us at enquiries@reachready.co.uk for more information.

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What does it mean if a substance is in Annex XVII of REACH?

Annex XVII is the list of restrictions under REACH. Restriction is one of the two mechanisms in REACH used to address substances of concern. It can be used to regulate against risks to specific populations such as the general public or against more widespread health and/or environmental risks.

A restriction can ban or place limits on any substance or substance type which poses an unacceptable risk to human health or the environment. A substance does not need to meet the SVHC criteria associated with the Authorisation process to be restricted.

If you are importing goods from non-EU suppliers you must ensure they meet any and all relevant restrictions. If you are are based in the EU and use substances listed in Annex XVII to run processes or make products you must ensure that your uses do not contravene Annex XVII restrictions.

Many of the Annex XVII restrictions were incorporated into REACH from old legislation such as Marketing and Use Directives. There have been numerous amendments to Annex XVII since it came into effect in June 2009; we have produced an unofficial consolidated version of Annex XVII to help our Gold subscribers keep track of the changes. Why not sign up today by clicking "join for free"?

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How much does REACH registration cost?

The total cost for a company to register a substance under REACH will be influenced by their individual company size and their annual tonnage band for the substance. It will also be affected by the level of sharing of administrative and data costs of the Substance Information Exchange Forum (SIEF). The cost of registration is difficult to predict but can be broken into a number of parts:

• Registration fee payable to ECHA, as defined in the Fees Regulation (EC) No. 340/2008. The fee is dependent on the company size (there are reductions for SMEs) and on the tonnage band of the company’s registration. Companies claiming confidentiality on certain information, or opting out of a joint submission with other registrants of the same substance incur additional costs.
• Cost of individual substance identity characterisation data: every registrant must submit analytical data on their substance to prove its identity.
• Cost of a Letter of Access, proving the registrant’s right to cite the shared physical, chemical, toxicological, ecotoxicological data contained in the Lead Registration dossier.
• Cost of resources: internal and external, including legal fees and administrative / management fees for the SIEF or Lead Registrant.

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How can companies manage REACH?

How a company prepares for REACH implementation will depend on its commercial activities. Examples of activities that companies are currently taking include:

• Setting-up administrative and product management systems to facilitate complying with REACH when it enters into force
• Developing portfolios of substances affected by REACH and identifying gaps in the information currently available and that likely to be needed
• Preparing for the 2013 registration deadline by contacting other (potential) registrants in the SIEF
• Reviewing and improving available data (e.g. contained in Safety Data Sheets)
• Communicating the potential business impact of REACH with suppliers & customers.

REACHReady is able to advise companies on what they can practically 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 or through our Matchmaker service.

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Has this whetted your appetite?

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