| For our Gold Service subscribers, we are available to answer all your REACH and CLP questions through our REACHReady Helpdesk, manned by our expert staff. |
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 the important stages of REACH and CLP, when they have to be complied with, and how. We also give advice on what downstream users of chemicals are required to do under REACH – and much more besides.
|
| 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... |
 |
|
| |
| What is CLP ? |
|
CLP is the Classification, Labelling and Packaging Regulation No. 1272/2008 and is the EU's implementation of the UN's Globally Harmonized System of Classification and Labelling of Chemicals (GHS). It is a Regulation rather than a Directive and therefore applies directly across the EU without being transposed into the national law of any or each of the Member States.
CLP is a very new regime for the EEA involving new "pictograms", warning phrases, hazard statements, and criteria, with larger and more colourful labels too. Some chemicals not subject to labels under the old classification and labelling regime will now need labelling; some chemicals with relatively mild warnings will be labelled in a much more severe way.
The legislative text of the CLP Regulation is found at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32008R1272:EN:NOT |
| Top |
| What chemicals are within the scope of CLP and which are exempt? |
|
CLP applies to all substances and mixtures imported, manufactured, or placed on the market within the EEA unless otherwise exempt. The Regulation does not apply to:
- Radioactive substances and mixtures within the scope of Council Directive 96/29/Euratom
- Substances and mixtures in Customs control which are not subject to treatment or processing
- Waste as defined in Directive 2006/12/EC
- Non-isolated intermediates
- Substances and mixtures for scientific research and development which are not placed on the market
- The transport of dangerous goods
In addition, Member States may grant exemptions in specific cases for certain substances or mixtures where necessary in the interests of defence.
There are also exemptions for substances and mixtures in their finished state in the following areas:
- Medicinal products for humans and animals as defined in Directives 2001/83/EC and 2001/82/EC respectively
- Cosmetic products as defined in Directive 76/768/EEC
- Medical devices as defined in Directives 90/385/EEC, 93/42/EEC and 98/79/EC
- Food or feeding stuffs as defined in Regulation (EC) No 178/2002
|
| If you are unsure if CLP applies to you and your products, contact us for more information and details of our Helpdesk and Consultancy services. |
| Top |
| What are the general obligations? |
|
Classification: In general, manufacturers, importers and downstream users of substances and mixtures to be placed on the market must check if those chemicals meet the criteria for classification.
Labelling:
A supplier must label his substances and mixtures to the CLP requirements before placing them on the market in order to communicate hazard information. Safety Data Sheets must also be provided to business customers where the chemicals are hazardous.
Notification:
Companies who place substances on the market must submit a notification to the Classification and Labelling (C&L) Inventory established by ECHA details of the classification and labelling. This obligation applies to those suppliers who:
- Manufacture or import a substance subject to REACH registration
- Manufacture or import a hazardous substance, irrespective of tonnage
- Import an article containing substances subject to registration under REACH Article 7 (intentional release)
- Import a mixture containing a hazardous substance above certain limits which results in the classification of the mixture as hazardous.
|
| Top |
| Can non-EU companies appoint an Only Representative for CLP? |
|
There is no provision in the CLP regulation for the appointment of an Only Representative.
If, for confidentiality reasons, a non-EU supplier does not want to disclose the required information to each importer they may nominate one importer to receive the information and notify on behalf of the other importers. An Only Representative could become an importer by taking a small sample of the substance or mixture in question and thus submit the notification on behalf of the EU importing customers.
Note that in the case of notification to the C&L Inventory, an Only Representative may submit the information needed for notification as part of a REACH registration dossier.
If an Only Representative has already registered the substance under REACH, the importers do not need to submit a separate notification.
|
| Top |
| I am a Downstream User obtaining chemicals from EU suppliers. Do I need to submit a notification to the C&L Inventory? |
|
No. Notification only applies to companies who import or manufacture and place on the market substances in scope of notification.
|
| Top |
| Does CLP apply to EU producers or importers of articles? |
|
CLP only affects EU producers or importers of explosive articles (as described in Section 2.1 of Annex I to CLP) or where
REACH Article 7 or 9 provides for registration or notification of a substance contained in
an article.
|
| Top |
| My substance was listed in Annex I of the Dangerous Substances Directive (67/548/EEC) with a harmonised classification. Is there such an agreed classification under CLP? |
|
Annex I of the Dangerous Substances Directive (DSD) ceased to have legal effect when CLP entered into force on 20 January 2009.
The list of harmonised substance classifications and labelling requirements were immediately incorporated into Annex VI of the CLP regulation. In Annex VI of REACH, the classification and labelling according to CLP is given in in Table 3.1 and that according to the DSD in Table 3.2. Amendments to this list are made through Adaptations to Technical Progress (ATP).
To search for the current harmonised classification and labelling requirements of a substance, we recommend the European Commission's database at http://esis.jrc.ec.europa.eu/index.php?PGM=cla
|
| Top |
| Do I need to submit a notification to the C&L inventory for a substance with harmonised classification? |
|
A company importing or manufacturing and placing on the market a substance listed in Annex VI of CLP and in scope of the C&L notification duty (see also our FAQ on CLP obligations) must notify their substance to the C&L inventory. They are required to notify the harmonised classification given in Annex VI of CLP.
|
| Top |
| What is the timescale for CLP implementation? |
|
For substances, the CLP obligations began on 1 December 2010, and for mixtures they begin on 1 June 2015. However, here are complex transitional arrangements from the old regime to CLP; for certain substances and mixtures the deadlines for re-packaging and re-labelling to CLP are two years later. There are also options for companies to implement CLP early.
From 1 December, suppliers have 1 month from placing the material on the market to submit their notification to the Classification and Labelling Inventory.
|
| If you would like advice on how the transitional period applies to you, contact us for more information and details of our Helpdesk and Consultancy services. |
| Top |
| Where can I find the official CLP hazard pictograms? |
|
The hazard pictograms are found on the UN's website at http://www.unece.org/trans/danger/publi/ghs/pictograms.html. There are .gif files in RGB, .eps files in CYMK, and "label" format .tif files which are 45°-rotated picture for direct label printing in CYMK. Note that there is no specified Pantone number for the red colour.
|
| Top |
| I import and supply hazardous substances in the EU. Whose contact information should be stated on the label, those of my non-EU supplier or mine as the importer? |
|
As the EU supplier the importer must include their legal entity name, address and telephone number on the label. The non-EU supplier's information is not required.
|
| Top |
| |
|
| |
| How is the REACH legislation organised? |
|
| 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. |
| Top |
| Where can I find the current REACH legislative text and Technical Guidance Documents? |
|
You can find the legislative text here. The latest updates to a number of the Annexes are also available:
Annex II
Annex IV, V
Annex XI
Annex XIV
Annex XVII: June 2009, March 2010, April 2011, May 2011 and its corrigendum.
These documents form the main REACH legal text, and differ to the previous versions of REACH.
Our Gold subscribers can download the many of the REACH technical guidance documents from the "Technical Downloads" section of our website. They are also available from the ECHA website. Exclusively for our Gold customers, REACHReady is continuously developing and updating a set of guidance documents to help explain the intricacies of REACH – click "join for free" to access them!
|
| Top |
| What are the objectives of REACH? |
|
| 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. |
|
| 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. |
|
| 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 formulating and developing REACH has been to achieve the right balance between these potentially competing objectives. |
| Top |
| Why has a new EU chemicals strategy been developed? |
|
| 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. |
|
| 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. |
|
| 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. |
| Top |
| How does the REACH process work? |
|
| 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, ECHA. |
|
| For existing (phase-in) substances deadlines apply largely on the basis of tonnage. ECHA will manage a database, which will contain the registration dossiers and other information generated by REACH and co-ordinate the implementation of REACH. |
|
| Once a substance is registered, ECHA will perform a completeness check of the registration dossier. ECHA will perform a quality evaluation for a minimum percentage of dossiers (currently 5% of them). All proposals for testing will be evaluated. ECHA, 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. |
|
| 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. |
| Top |
| REACH is a complicated piece of legislation. What help is available to stakeholders in implementing its requirements? |
|
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 official Guidance Documents can also be found on the ECHA website. |
|
| 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 through our subscriptions, training courses and consultancy services and our free REACHMatchmaker programme! |
| Top |
| Who does REACH apply to? |
|
| 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 into 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 Articles into the EU from elsewhere in the world you may be interested to view a webinar recorded on 26 Jan 2011 called "Exporting Goods to the European Union - REACH and the Implications for SVHCs".
To access the recording use the following link & enter your contact details - http://w.on24.com/r.htm?e=274040&s=1&k=403C1D849736C6230CA88C883FF359BD |
| Top |
| 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. |
| Top |
| 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. |
| Top |
| 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 disruptors.
|
|
| 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/web/guest/candidate-list-table
Publication of the Candidate List triggers immediate legal obligations for many companies within the EEA. |
|
| I am a supplier of finished goods based in the EEA. My products contain substances on the Candidate List. What are my obligations? |
Companies in the EEA 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. Notification formally began in June 2011 and is via the REACH-IT web portal.
There is a summary of the Candidate List obligations on the ECHA website at http://echa.europa.eu/web/guest/candidate-list-obligations
|
|
| 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 taken from the Candidate List of substances. Substances included in Annex XIV are tightly regulated such that their use must be permitted specifically by ECHA, 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. |
|
| 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 enquirires@reachready.co.uk for more information. |
| Top |
| 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. |
|
| Top |
| How can companies manage REACH? |
|
| How a company manages its REACH implementation will depend on its commercial activities. Examples of ongoing activities that companies are currently taking include: |
|
|
Maintaining 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 is needed |
|
Reviewing and improving available data (e.g. contained in Safety Data Sheets) |
|
Updating their registration dossiers for registered substances |
|
Working with fellow SIEF members towards registration for the next phase-in deadline, 31 May 2013 |
|
Communicating the potential business impact of REACH with suppliers and customers. |
|
|
| REACHReady is able to advise companies on what they should be doing now to manage REACH compliance. We can also direct you to those best placed to offer specific help and support in the form of consultancy through our REACHMatchmaker programme. |
| Top |
| Has this whetted your appetite? |
|
| 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. |
|
| To take advantage of the full range of REACHReady benefits, sign up to Gold Service today!
Click here for further details
|
