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Introduction 

REACH is one of the main acts of the European legislation on chemicals. Its aim is to improve the protection of human health and environment from the risks arising from the use of chemicals. REACH makes the industry responsible for evaluating the risks of the chemicals they use and produce. REACH requires detailed information on the risks and the safe use of chemical substances and this information is passed down the supply chain through safety data sheets.

Although REACH obliges manufacturers to assess the risks of chemicals they place on the European market, the employer remains responsible for ensuring occupational safety and health (OSH). According to the Chemical Agents Directive 98/24/EC[1], employers are obliged to identify all the chemical hazards at the workplace, carry out risk assessments and act on them.

The principles of protecting workers from the risks related to exposure to carcinogens, mutagens or reprotoxic substances at work are set out in the Carcinogens, Mutagens and Reprotoxic substances Directive 2004/37/EC[2].

What is the REACH Regulation?

REACH is the acronym of EU Regulation No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals[3]. REACH entered into force on 1 June 2007 and has been implemented in different phases until 2018. REACH also established the European Chemicals Agency (ECHA),

The main goal in REACH is to secure a high level of health and environment protection from chemical hazards. In addition, REACH intends to create better markets for safer substitutes and to enable the introduction of new technologies and methods to evaluate chemical risks. REACH also improves worker’s health and safety by providing better information, by establishing channels of communication between employers and suppliers and by removing substances of very high concern from the market[4]. REACH clearly stipulates in art. 2.2.4 that the Regulation applies ‘without prejudice’ to Community workplace (e.g. OSH Framework Directive[5]) and environmental legislation emphasising that the provisions of REACH must be complied with, but that this does not mean that existing legislation on the workplace and the environment will be removed or reduced. This legislation remains unchanged and must also be complied with.

REACH applies to chemical substances and mixtures. There are exemptions on medical, veterinary, alimentary and cosmetic products, polymers and some on-site isolated intermediates.

REACH, together with the CLP Regulation (1272/2008/EC on classification, labelling and packaging of substances and mixtures)[6], is considered the cornerstone of the European legislative framework on chemicals. Reinforcing both REACH and CLP is part of the EU Chemicals Strategy for Sustainability Towards a Toxic-Free Environment. The strategy was published in 2020 and strives, in line with the European Green Deal, for a toxic-free environment, where chemicals are produced and used in a way that maximises their contribution to society including achieving the green and digital transition, while avoiding harm to the planet and to current and future generations[7].

 

Registration

REACH requires manufacturers and importers of chemical substances (quantities of one tonne or more per year) to register the substances with the European Chemicals Agency (ECHA). The registration dossier to be submitted to ECHA contains the hazard information and, where relevant, an assessment of the risks that the use of the substance may pose and how these risks should be controlled[8]. Potential manufacturers and importers of substances must submit an inquiry to ECHA and register the substance before they can manufacture or import the substance. Manufacturers and importers of the same substance have to submit their registration jointly[8]. ECHA provides a database with all registered substances including  information like classification and labelling; identified uses; physical and chemical properties; toxicological properties; and guidance on safe use on its website[9].

The chemical safety report documents the chemical safety assessment undertaken as part of the registration process and is the key source of information to all users of chemicals and for REACH processes such as authorisation[10]. It should be readily understandable in all its parts as a stand-alone document and it should include all the relevant information for the chemical safety assessment. The chemical safety assessment is conducted to demonstrate that the risks of exposure to a substance during its manufacture and use are controlled when specific operational conditions and risk management measures are applied. These conditions of use of a substance constitute the exposure scenario[10]. An exposure scenario is the set of conditions that describe how the substance is manufactured or used during its life cycle and how the manufacturer or importer controls, or recommends others to control, exposures of humans and the environment. In the chemical safety assessment, the risks associated with each use of the substance have to be evaluated, and adequate risk management described. All the information for ensuring safe use is forwarded down the supply chain in form of a safety data sheet.

Safety data sheets and exposure scenarios

A safety data sheet (SDS) is a document that provides information about the properties and safe use of the chemical. It has to be delivered to downstream users with the first supply of a hazardous chemical substance or mixture. The manufacturers, importers or suppliers of the product provide safety data sheets. An SDS must be supplied in the official language(s) of the Member State and it has to be consistent with the chemical safety report. Annex II of the REACH regulation describes the requirements for the compilation of Safety Data Sheets. An extended SDS includes exposure scenarios that describe how the manufacturer or importer recommends downstream users to control, the exposure of humans and the environment to the substance in order to ensure its safe use.

More guidance is available at the ECHA website, for example the fact sheet Safety data sheets and exposure scenarios[11].  The sections of an SDS are listed in Table 1. 

REACH does not specify the format or content of an exposure scenario but ECHA and stakeholders have agreed on the following main sections[11]:

  • Title section;
  • Conditions of use affecting exposure;
  • Exposure estimation (this may include the risk characterisation ratio); and
  • Guidance to downstream users to evaluate if their use is within the boundaries of the exposure scenario.

To support suppliers in carrying out the chemical safety assessment and elaborate the exposure scenarios, ECHA provides the Chesar IT-tool[12].  

Table 1: Content of the safety data sheet

Sections 
1. Identification of the substance/mixture and of the company/undertakingIdentified uses, product identifier, contact details of the supplier of the safety data sheet, references to emergency information services
2. Hazard identificationClassification and labelling information according to the CLP regulation. Authorisation number if relevant.
3. Composition/information on ingredientsHazards of the components of the substance/mixture. Product identifiers of the components.
4. First aid measures-
5. Fire-fighting measures-
6. Accidental release measures-
7. Handling and storage-
8. Exposure controls/personal protectionApplicable occupational exposure limits and necessary risk management measures. Information must be consistent with the exposure scenarios.
9. Physical and chemical properties-
10. Stability and Reactivity-
11. Toxicological information-
12. Ecological information-
13. Disposal considerationsInformation on proper waste management
14. Transport information-
15. Regulatory informationInformation if the substance as such or in a mixture is subject to authorisation or restriction. Information if the chemical safety assessment has been carried out.
16. Other informationRecommended restriction of use
Annex (if a chemical safety report is required)Relevant exposure scenarios

(Source: REACH, annex II)[3]

Exposure scenarios are important tools for improving the safe use of chemicals in Europe. ECHA has established the Exchange Network on Exposure Scenarios (ENES) together with the sector organisations Cefic, Concawe, Eurometaux, Fecc, and DUCC. This collaborative network aims to identify good practices on preparing and implementing exposure scenarios, and to develop an effective communication exchange between supply chain actors to improve the protection of human health and the environment.

Which chemicals are covered and who are the actors in REACH?

REACH covers all chemical substances and mixtures with a few exemptions. It does not cover radioactive substances, substances under custom supervision, waste, and substances which are used for military purposes. In addition, non-isolated intermediates that during synthesis are not intentionally removed from the synthesis equipment are exempted from REACH, and for isolated intermediates, a simplified registration applies. REACH exemptions are listed in the REACH Annex IV and V.

REACH and CLP cover nanomaterials when they occur as forms of substances or mixtures. Since January 2020[13] REACH includes explicit legal obligations for manufacturers or importers of nanoforms. They must assess whether the risks arising from the identified uses of the substance with nanoforms are adequately controlled. To ensure clarity, the chemical safety report should describe whether and which different nanoforms are covered by the assessment and how the information is compiled in the report[13].

Some substances are exempt only from the registration. These are naturally occurring substances like minerals, ores and natural gases. Food or feeding products, medical products and devices, cosmetics, plant protection chemicals and transportation of dangerous substances are also exempted because they are regulated by specific legislation.

The European Chemical Agency (ECHA) is responsible for the evaluation, authorisation and restriction processes. ECHA receives and evaluates all the registration dossiers, gives companies advice and produces guidance documents for the implementation of REACH. Member States’ competent authorities for REACH co-operate with ECHA and with other Member States’ competent authorities. Member States’ competent authorities also guide the national enforcement authorities, and are in charge of national REACH helpdesks.

There are different kinds of actors or stakeholders in REACH. The main types of actors are industry, authorities and third parties. Within the industry, there are manufacturers and importers of substances, producers and importers of substances in articles, companies using the substances (downstream users) and companies delivering the substances (distributors). In REACH, the term ‘importer’ always refers to an EU-importer who delivers substances or substances in articles from outside the EU.

A downstream user can be any professional or industrial user of a chemical; the use can vary a lot, from formulating of chemical mixtures to spray-painting and manufacturing electronic components. It has to be emphasised that one company may have several roles under REACH. Companies can find out what their REACH roles and obligations are by answering to questions asked. The webpage Getting started on the ECHA website helps to identify the different roles within REACH[14].

Substances of very high concern and authorisation

Before REACH, only new substances (introduced after 1981) had to be tested and notified by the industry before placing them on the market. Risk assessment of existing substances (substances placed on the EU market between 1971 and 1981) was done in cooperation with Member States. The Commission set a priority list based on the hazardous properties of the substances. The full list of existing substances selected for such an assessment contained 141 substances out of the ten thousands of substances notified to the European Inventory of Existing Commercial chemical Substances (EINECS).

In the REACH authorisation process, the goal is to ensure adequate risk management of substances of very high concern (SVHC) and to find safer alternatives The substances are identified by the member state competent authorities or the Agency and listed in a candidate list based on the Commission’s recommendation. These SVHC-substances include carcinogenic, mutagenic or reprotoxic (CMR) substances (categories 1A and 1B), substances which are persistent, bio-accumulative and toxic for environment (PBT, vPvB), and substances with corresponding serious effects to humans or to the environment (e.g. endocrine disrupting agents).

After identification, substances are prioritised in a consultation process with the interested parties (e.g., manufacturers, importers, downstream users, NGOs), who are asked to comment on or provide information on uses, exposure, availability of safer alternatives and proposals for uses which should be exempted from authorisation to ECHA. The European Commission, in collaboration with Member States and the European Parliament, then decides which uses should be subject to authorisation and which substances should be included in the list of substances of very high concern (REACH regulation Annex XIV). After a substance is listed in Annex XIV, it cannot be used without an authorisation from ECHA. To get the authorisation, the applicant has to demonstrate safe conditions of use. The authorisation application includes a chemical safety report, an analysis of substitution by identifying the possible alternative substances or technologies, a substitution plan and in some cases a socio-economic analysis.

Companies should be aware of possible SVHC substances they use and strive to substitute them. It is also important to keep an eye on the candidate list, which is continuously updated and enlarged[15]. If a company intends to use an SVHC substance, it needs to apply for authorisation, although in many cases the registrant will take care of the authorisation on behalf of downstream users. If that is the case, the downstream users have to make a notification for ECHA within three months after the first supply. All the authorisations are for a limited time period and will be regularly re-evaluated[16].

Restriction of use

Manufacturing and use of substances that may pose unacceptable risks to human health or environment can be limited or banned by the REACH restriction process. Restrictions are set by the Commission and are always Community-wide. Restrictions can be set for all the uses or only for specific uses of the substance and there is no tonnage limit. The restriction is considered as a ‘safety net’ to control risks that are not covered by other REACH processes. All the restrictions are included in the REACH regulation (Annex XVII). 

If the substance on its own or as part of a preparation or an article is subjected to restriction, companies have to comply with the restrictions and risk management measures communicated in the safety data sheet when using the substance. If the use of the substance is banned, companies have to stop the use by the date specified in annex XVII of REACH. Information on whether the substance is subject to restrictions can be found in section 15 of the safety data sheet. All restricted substances are also listed in a searchable database on the ECHA website[17].

Obligations for downstream users and guidance documents

Even though in most cases the downstream users are not responsible for the registration and data gathering, they do have obligations under REACH. The most important obligation for downstream users is to make sure that all the substances which are used in the company are adequately pre-registered or already registered for their specific uses. This means that companies have to communicate with their suppliers to ensure the registrations are done. Downstream users must identify and apply appropriate measures to control the risks which are described in the safety data sheets received from their suppliers and follow the instructions in it or in exposure scenarios which may be attached to some safety data sheets. Downstream users have 12 months for implementing the risk management measures. The deadlines specified for compliance start from the day they receive a safety data sheet (SDS) with a registration number[18].

It is important that companies check carefully the safety data sheets as soon as they receive one. 

If a company is formulating dangerous chemical substances or mixtures, it is obliged to take care that all information needed to ensure safe use of substance is forwarded to the customers by providing safety data sheets. It is important to include all the relevant information from exposure scenarios and safety data sheets which the formulator has received from the supplier.

In addition to the obligation to pass the information down the supply chain, the downstream users are obliged to provide information up to the suppliers and registrants. For example in case a use is not covered with an exposure scenario, the user has to ask the supplier to request the registrant to consider that specific use as an identified use and deliver an exposure scenario for it. In case the downstream user wants to keep the use confidential, he has to prepare a downstream user chemical safety report himself[18].

Employers’ obligations resulting from the REACH legislation

All downstream users should pay attention to the REACH legislation by inquiring whether the chemical substances needed in their processes and uses are registered. Only identified uses with descriptions of risk management measures ensuring safe use are allowed. The extended safety data sheets will bring more information about risk management for dangerous substances.

The approach for controlling hazardous chemicals at the workplace according to the European Commission guidance for employers includes the following main points[4]:

  • Identify all the hazardous chemical agents at the workplace.
  • Check the safety data sheet and relevant exposure scenarios.
  • Inform the supplier about your use, if necessary.
  • Substitute all the hazardous substances to less dangerous alternatives, if possible.
  • If substitution cannot be applied, assess the risks to the health and safety of workers.
  • Compare the existing risk management and REACH risk management measures and make changes if necessary. When considering risk management, remember the priority rules for it.

 

How the REACH and OSH regulations fit together

REACH includes obligations for manufacturers and regulates the placing on the market of chemicals. Therefore, it does not interfere with the occupational health and safety requirements, but is complementary. 

REACH applies to chemical substances, mixtures and substances in articles while OSH regulations deal with the use of chemicals at workplaces[4] where usually several chemical mixtures are used simultaneously. OSH regulations cover all substances that may pose a risk to workers, including those not included in REACH, for example those produced by the work process and natural substances.

Both REACH and CLP have created a comprehensive and protective regulatory framework for chemicals that supports the efficient functioning of the internal market for chemicals, reduces the risks to humans and the environment posed by hazardous chemicals[19]. The use of several of the most hazardous substances has been restricted, thereby helping reduce work-related exposures. REACH and CLP have also improved the availability of reliable information on the properties and safe use of chemicals[20].

In REACH, the risk assessment is done for each substance and the results and risk management measures are communicated to workplaces via a safety data sheet/exposure scenarios. OSH regulation on the other hand requires the employers to identify all the risks at workplace. The risk assessment processes are different. The results of the risk assessment and the exposure scenarios generated by registrants in the context of REACH are by nature “generic”, whereas the OSH risk assessment process is intended to include workplace and task specific information in a comprehensive way. The information included in exposure scenarios can provide useful information for the OSH risk assessment and taking appropriate prevention measures but is not always easily understandable for the OSH practitioners [21].  Furthermore, OSH risk assessment is not limited to chemical substances or mixtures but involves chemical agents in general including process related exposures, like welding fumes

REACH has introduced limit values applicable in cases where a chemical safety report is required: ‘Derived No Effect Levels (DNELs)’. DNELs are derived in a chemical safety assessment as an exposure reference level based on human health and environmental effects. DNEL means the level or dose which should not be exceeded when the risk management described in an exposure scenario is in use. Different DNELs are set for each exposure route (inhalation, skin and oral) and for different population groups like workers and consumers. Occupational exposure limit values (OELs) are set by OSH legislation while DNELs work as a tool for setting adequate risk management in REACH. OELs are established by regulatory authorities using extensive scientific input. An OEL usually represents an airborne concentration at which it is unlikely that significant adverse health effects occur in the overwhelming majority of an exposed workforce.

In the workplace there might be situations where both DNELs and OELs apply simultaneously to the same task or activity. A study comparing OELs and DNELs found that many more chemical substances are covered by DNELs than by OELs but on the other hand, no DNEL is available for many occupationally relevant pollutants because they are not covered in REACH. If a DNEL and an OEL is available for the same substance, they are often quite similar but sometimes there are large differences. Among the 418 substances that were studied, 27 (6.5%) had a DNEL that was more than 10 times higher than one or several OELs[22]

The key point for effective prevention is to apply the appropriate control measures taking into account the measures in the safety data sheets and the specific conditions of the workplace (other substances used, temperature, equipment, fire protection, etc.)

In REACH, the substances identified as being of very high concern must be replaced with safer alternatives or techniques when possible. If a company intends to use an SVHC substance, it needs to apply for authorisation, or if the registrant has taken care of the authorisation on behalf of downstream users to make a notification for ECHA within three months after the first supply. All the authorisations are for a limited time period and will be regularly re-evaluated.

In OSH legislation the requirement to eliminate risks does not only apply to substances of very high concern, but to all chemical risks, and for carcinogenic, mutagenic and reprotoxic substances stricter requirements are set. In the context of workplace health and safety regulation, substitution means that the employer has to eliminate or minimise risks and replace the hazardous substance or choose the least hazardous chemical or working process.

Références

[1] Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work. Available at:  https://osha.europa.eu/en/legislation/directives/75 

[2] Directive 2004/37/EC on the protection of workers from the risks related to exposure to  carcinogens, mutagens or reprotoxic substances at work. Available at:  https://osha.europa.eu/en/legislation/directive/directive-200437ec-carcinogens-or-mutagens-work 

[3] Regulation 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Available at: https://osha.europa.eu/en/legislation/directives/regulation-ec-no-1907-2006-of-the-european-parliament-and-of-the-council 

[4] EC – European Commission DG Employment, Social Affairs and Equal Opportunities, Guidance for employers on controlling risks from chemicals - Interface between Chemicals Agents Directive and REACH at the workplace, Social Europe, 2010. Available at: https://osha.europa.eu/en/legislation/guidelines/guidance-employers-controlling-risks-chemicals-interface-between-chemicals-agents-directive-and-reach-workplace 

[5] Framework Directive 89/391/EEC on the introduction of measures to encourage improvements in the safety and health of workers at work. Available at: https://osha.europa.eu/en/legislation/directives/the-osh-framework-directive/1 

[6] Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. Available at: https://osha.europa.eu/en/legislation/directives/regulation-ec-no-1272-2008-classification-labelling-and-packaging-of-substances-and-mixtures 

[7] EU Commission. Chemicals strategy. The EU’s chemicals strategy for sustainability towards a toxic-free environment. Available at: https://environment.ec.europa.eu/strategy/chemicals-strategy_en 

[8] ECHA - European Chemicals Agency. REACH – Registration. Available at:  https://echa.europa.eu/regulations/reach/registration 

[9] ECHA - European Chemicals Agency. Database registered substances. Available at: https://echa.europa.eu/information-on-chemicals/registered-substances 

[10] ECHA - European Chemicals Agency. Chemical safety report. Available at:  https://echa.europa.eu/regulations/reach/registration/information-requirements/chemical-safety-report 

[11] ECHA - European Chemicals Agency. Safety data sheets and exposure scenarios. Factsheet. Available at: https://echa.europa.eu/documents/10162/1854937/downstream_sds_en.pdf/f3963ab4-4691-427b-97cc-f0d4b39368e9?t=1478685967822 

[12] ECHA - European Chemicals Agency. Practical examples of exposure scenarios. Available at: https://echa.europa.eu/support/practical-examples-of-exposure-scenarios 

[13] Commission 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. Available at: http://data.europa.eu/eli/reg/2018/1881/oj 

[14] ECHA - European Chemicals Agency. Getting started. Available at:  https://echa.europa.eu/support/getting-started 

[15] ECHA - European Chemicals Agency. Candidate List of substances of very high concern for Authorisation. Available at: https://echa.europa.eu/candidate-list-table 

[16] ECHA - European Chemicals Agency. Submitting downstream user notification of authorised uses. Available at: https://echa.europa.eu/support/dossier-submission-tools/reach-it/downstream-user-authorised-use 

[17] ECHA - European Chemicals Agency. Substances restricted under REACH. Available at: https://echa.europa.eu/substances-restricted-under-reach 

[18] ECHA – European Chemical Agency. Guidance document for downstream users, 2014. Available at: https://echa.europa.eu/documents/10162/2324906/du_en.pdf/9ac65ab5-e86c-405f-a44a-190ff4c36489 

[19] EU Commission. Communication on the Chemicals Strategy for Sustainability. Towards a Toxic-Free Environment, 14.10.2020. COM(2020) 667 final. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2020%3A667%3AFIN 

[20] ECHA - European Chemicals Agency. Report on the Operation of REACH and CLP 2021. Available at: https://echa.europa.eu/documents/10162/17226/operation_reach_clp_2021_en.pdf/e271b3c8-137a-48ad-30ad-499249235ee5 

[21] Cefic. Cefic’s views on the interplay between REACH & OSH legislation. Position paper, 3 December 2020. Available at: https://cefic.org/app/uploads/2021/02/Cefics-views-on-the-interplay-between-REACH-and-OSH-legislation.pdf 

[22] Schenk, L., & Johanson, G. Will worker DNELs derived under the European REACH regulation extend the landscape of occupational exposure guidance values?. Archives of Toxicology, 2019, 93(5), 1187-1200. Available at: https://link.springer.com/article/10.1007/s00204-019-02439-0 

Lectures complémentaires

EU-OSHA – European Agency for Safety and Health at Work, Practical tools and guidance on dangerous substances. Available at: https://osha.europa.eu/en/themes/dangerous-substances/practical-tools-dangerous-substances

EU-OSHA – European Agency for Safety and Health at Work, Info sheet: Legislative framework on dangerous substances in workplaces, 2018. Available at: https://osha.europa.eu/en/publications/info-sheet-legislative-framework-dangerous-substances-workplaces 

EU-OSHA – European Agency for Safety and Health at Work, Info sheet: Substitution of dangerous substances in the workplace, 2018. Available at: https://osha.europa.eu/en/publications/info-sheet-substitution-dangerous-substances-workplace 

EU-OSHA – European Agency for Safety and Health at Work, Training course: Substitution of dangerous substances in workplaces, 2021. Available at: https://osha.europa.eu/en/publications/substitution-dangerous-substances-workplaces/view-0 

EU Commission. How REACH works. Available at: https://single-market-economy.ec.europa.eu/sectors/chemicals/reach/how-reach-works_en 

ECHA, European Chemicals Agency https://echa.europa.eu 

Contributeur
Klaus Kuhl

Niina Kallio

Finnish Institute of Occupational Health

Richard Graveling

Karla Van den Broek

Prevent, Belgium