REACH FAQ

You can find the initial REACH legal text and the latest official consolidated version here. In addition, there are also separate implementing regulations that have been introduced over the years covering for example Fees, Test method and data sharing.

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

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

ECHA manages the REACH-IT web portal and database, which receives and stores 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 IUCLID dossier. ECHA also performs a dossier “evaluation”, a check of compliance and quality, for a proportion of dossiers submitted. Proposals for testing are also evaluated. ECHA, in conjunction with Competent Authorities located in the Member States, may perform more detailed “substance evaluation” if the substance is considered to be of potential concern and is included in the Community Rolling Action Plan (CoRAP). Supplementing the substance evaluation work is voluntary risk management option (RMO) analysis, which helps the authorities determine the most appropriate regulatory measures to address risk on an EU-wide basis.

Substances that are identified as being of very high concern to human health or the environment are included in the ever-growing Candidate List - these substances are the so-called SVHCs that may be subject to “authorisation”. This control process allows EU/EEA-wide control of substances identified as causing unacceptable risk to human health or the environment. The ”restriction” process is also used to control unacceptable risks in certain applications or products, or to specific or wider populations or the environment.

ECHA publishes a range of guidance documents, fact sheets, “guidance in a nutshell” and more practical guides on the use of REACH-IT and IUCLID. Copies of the latest versions are available from the ECHA website.

Even with these official - and very comprehensive - sources of support freely available, there remains a degree of complexity with REACH implementation – REACHReady can help understand how to comply cost-effectively through our subscriptions, training courses and consultancy services, and through our free Matchmaker programme if you are looking to outsource!

REACH is an EU Regulation, acting directly in all EU Member States. It also applies to the countries of the European Economic Area, EEA, namely Iceland, Liechtenstein and Norway. Any EEA legal entity 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 legal entities importing products to the EEA market.

A non-EU/EEA manufacturer has the option of appointing an “only representative” to meet the registration requirements of REACH on its behalf for all its EU/EEA 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, companies in the same substance group may appoint a leader for the purposes of registration, possibly a third party, to organise and coordinate the registration process. In addition, manufacturers, importers, and downstream users can use third party representatives (TPRs) when participating in data sharing discussions to shield their identity from other (potential) registrants, who may well be competitors.

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

Substancesmanufactured in, or imported into, the EEA are subject to REACH, unless otherwise exempt. Some obligations (i.e. those relating to Safety Data Sheets) also apply to mixtures themselves.

Outside the scope of the regulation entirely are:

• Radioactive substances within the scope of Council Directive 96/29/Euratom of 13 May 1996;
• Substances, on their own, in mixtures or in articles, which are under Customs supervision (for example in a free zone or bonded warehouse), provided that they do not undergo any treatment or processing, which are in temporary storage or in transit;
• Non-isolated intermediates;
• The carriage of dangerous substances alone or in dangerous mixtures (i.e. transport);
• Waste as defined in Directive 2006/12/EC as it is not a substance, mixture or article within the meaning of REACH Article 3.

REACH allows Member States to exempt certain substances from REACH in the interests of defence. However, the exemption normally requires an application or submission of information to the relevant body in the country in question. Contact us if you would like more information on how the defence exemption works in the UK.

Some of the provisions of REACH do not apply to substances to the extent that they are used in particular applications. However, if the substance is used in a non-exempt application or product then those parts of REACH may apply. For example, registration under Title II of REACH does not apply to substances used in medicinal products within the scope of Regulation (EC) No 726/2004, Directive 2001/82/EC, and Directive 2001/83/EC, or to substances used in foods in accordance with Regulation (EC) No 178/2002. You can find out more about these exceptions in Article 2 of REACH.

A number of substances are also excluded from the need to register either because the risk is expected to be low and/or registration would be a disproportionate requirement. You can find lists of such substances and substance types in the  Annexes IV and V.

The requirements for safety data sheets and other communication in the supply chain duties do not apply to certain mixtures (not substances) in the finished state, intended for the final user:

• Medicinal products;
• Cosmetic products;
• Food or feeding stuffs.

The short answer is “yes”, but that isn’t the end of the story.

In 2011, the European Commission published a recommendation on the definition of a nanomaterial; it concluded the following year that REACH and CLP offered the best possible framework for risk management of nanomaterials occurring as substances or mixtures. However, it was felt that the regulations need more specific requirements in order to address the properties and risks of these materials. The European Commission in modifying some of the technical provisions in the REACH Annexes conducted public consultations and impact assessments to ensure further clarity on how nanomaterials are addressed, and safety demonstrated, in registration dossiers.

REACH registration requirements for nanoforms of a substance are provided in the adopted Regulation (EU) 2018/1881 of 3 December 2018… amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances.

 Since 1 January 2020,  all companies manufacturing or importing nanomaterials above 1 tonne per annum, whether this is existing or new registrations, must meet these registration requirements.

 REACHReady Gold subscribers can gain access to further information via our nanomaterials page 

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.

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 are substances which are Candidate Listed because they are:

• Carcinogenic, Mutagenic or toxic to Reproduction (CMR) classified in category 1A or 1B, or
• Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation, 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.

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 by the process of authorisation (the “A” of REACH). A Candidate Listed substance may subsequently be added to Annex XIV of REACH – the list of substances subject to authorisation – which would mean the EU/EEA use and supply for use must be authorised by the European Commission (unless the use is exempt from the authorisation process).

The Candidate List is published on the ECHA website.

Publication of the Candidate List triggers obligations for many companies within the EU/EEA, particularly suppliers of articles; the candidate list is usually updated twice a year, in June and December. To see how your business might be affected why not come along to our next articles workshop?

REACH defines an article as an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition. These include commonly used objects such as books, laptops, toys etc. Your obligations under REACH are dependent on your role as a producer, an importer or a supplier of articles.

Any importer or producer of articles may be required to register a substance in articles if it is intended to be released from the articles during normal or reasonable foreseeable conditions of use and the total amount of the substance present in all articles produced and/or imported, from which the substance is intended to be released, exceeds 1 tonne per year.

Producers or importers also have to notify the European Chemicals Agency (ECHA), if a Candidate Listed 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.

If you are an EU/EEA supplier of articles containing Candidate Listed substances present above 0.1% w/w you will have communication obligations under Article 33 of REACH. 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 Listed substance. You are also obliged to give the same information upon request to a consumer within 45 days of receipt of the request. From 5 January 2021, companies producing, importing or selling articles that contain substances of very high concern (SVHC) on the REACH Candidate List in a concentration above 0.1% w/w on the EU market are also required to submit information on these articles to the ECHA’s database which contains information on Substances of Concern In articles as such or in complex objects (Products) – SCIP.

Finally, articles must not be placed on the market if they breach any relevant Annex XVII restriction - a regular feature in the European Commission’s RAPEX reports on products posing serious risks to health, safety or the environment! The enforcement authorities also collaborate in EU-wide “REACH-EN-FORCE” projects to check levels of compliance with regards to specific obligations imposed by the regulation.

If you need to find out more about the implications of REACH, attending one of our training days may be the answer!

Authorisation is a REACH process which aims to ensure that the risks from Substances of Very High Concern are properly controlled, and that these substances are progressively replaced by suitable alternatives. Annex XIV of REACH is the list of substances subject to Authorisation, commonly known as the Authorisation List. 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 EU/EEA must not use a listed substance or supply it for use in the EU/EEA where specific authorisation to do so has not been granted, unless the use is exempt or a valid authorisation application is pending.

Please see here the Authorisation List.

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. If your company uses SVHCs that are candidates for inclusion in Annex XIV we can help you work out your strategy. If your substance is already on the Authorisation List and you need help in preparing an application for Authorisation, our free Matchmaker service can help. Contact us at enquiries@reachready.co.uk for more information.

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/EEA suppliers you must ensure they meet any and all relevant restrictions. If you are based in the EU/EEA and use substances listed in Annex XVII to run processes or make products you must ensure that your uses do not contravene the Annex XVII restriction(s).

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.

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.. 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 (as amended). 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 and composition;
• 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 substance group or Lead Registrant.

How a company manages its REACH compliance will depend to some extent on its commercial activities as well as its role under REACH (for example, manufacturer, importer, downstream user, distributor). Examples of activities that companies are currently taking include:

• Maintaining their existing registrations through updates when new information becomes available, their tonnage band increases or decreases, or when their legal entity changes;
• Updating Safety Data Sheets to ensure all relevant available information is included, in light of the registration deadlines passed and the C&L inventory;
• Assessing the impact on site practices of exposure scenarios;
• Considering alternative technologies or applying for Authorisation if they use or supply a (potential) Annex XIV substance.

REACHReady has a series of workshops designed to help companies manage their compliance issues, with different days tackling the issues facing Manufacturers and Importers of Chemicals, Downstream Users and suppliers of Articles. Check our training page for the latest details.

Unless exemption applies, REACH affects all chemicals, their associated mixtures as well as their presence in finished products. However, the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive applies only to certain hazardous chemicals in new electrical & electronic equipment. Some of these hazardous substances include Lead, cadmium, mercury, chromium VI, polybrominated biphenyl (PBB) and diphenyl ether (PBDE).

Although both pieces of legislation restrict the use of dangerous chemicals, the basis for RoHS and REACH substance restrictions are quite different. RoHS restrictions are based on hazards and whether there are potential alternatives, thus determining if a substance(s) in question should be banned. REACH restrictions are introduced only if a risk to human health or the environment can be proven, there are no adequate controls and substitutes exist. Further to this, RoHS restrictions can be imposed without a full assessment of the impact of the possible alternatives once there is enough evidence to prove potential risk. REACH restrictions are based on lengthy evidence-based risk assessments into the impact of the substance in its entire life cycle including possible alternatives and controlled measures used by the industry to minimise risk and social and economic issues.