REACH is the European chemical legislation, which has been described as the most important EU legislation for 20 years.REACH is the new European Union legislation applying to chemical substances, and its aim is to improve the protection of human health and environment from the risks arising from the use of chemicals. REACH sets the burden for industry to evaluate the risks related to the chemicals they use and produce. REACH will bring more detailed information from chemical substances and the information will be passed through the supply chain in the format of safety data sheet.
Although the risks related to substances are evaluated under REACH, the occupational health and safety legislation continue as before and employers are still the persons responsible for the workplace safety:
- According to the Chemical Agents Directive (98/24/EC), employers are obliged to identify all the chemical hazards at the workplace and carry out the exposure and risk assessments and act on them.
- The principles of protecting workers from the risks related to exposure to carcinogens or mutagens at work are set out in the Carcinogens and Mutagens Directive 2004/37/EC.
Previous European legislation on labelling dangerous substances (Dangerous Substance and Dangerous Preparations Directives for classification and labelling ) have now been replaced by the CLP-regulation (EC) No 1272/2008 for classification, labelling and packaging of substances and mixtures..
As part of the introduction of this legislation, industry was obliged to submit a notification of the hazard classification of all substances placed on the market before December 2010 to the European Chemicals Agency (ECHA) by January 2011, included in a classification and labelling inventory. This was expected to enhance the transparency and highlight the differences between classifications. The harmonisation of classification is done for CMR substances and respiratory sensitisers, but it is hoped that notification will harmonise also the other substance classifications over time. ECHA has opened a database called ‘Information on Chemicals’ where anyone can access the substance classifications.
The acronym REACH stands according to the EU Regulation No 1907/2006 for Registration, Evaluation, Authorisation and Restriction of Chemicals. REACH entered into force on 1 June 2007 and is being implemented in different phases until 2018.
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. The arrival of REACH should improve worker’s health and safety by providing better information, by establishing new channels of communication between employers and suppliers and by removing substances of very high concern from the market.
REACH shall apply without prejudice to Community workplace (Art. 2.2.4 of REACH) and environmental legislation. There are exemptions on medical, veterinary, alimentary and cosmetic products, polymers and some on-site isolated intermediates.
REACH requires manufacturers and importers of chemical substances (quantities of one tonne or more per year per company) to register the substances in the European Chemicals Agency (ECHA). The registrations are accomplished in phases depending on tonnage. To obtain this so-called phase-in registration, substances had to be pre-registered in 2008. The first registration deadline was in December 2010 when all the substances above 1,000 tonnes in addition to all the carcinogenic, mutagenic or reprotoxic substances (categories 1A and 1B, = 1 tonne/year), and substances classified as dangerous for the aquatic environment (= 100 tonnes/year), had to be registered. The next registration deadline is June 2018 for substances from 1 to 100 tonnes (see Figure 1).
The registration dossier to be submitted to ECHA includes a technical dossier for all the registered substances, and additionally a chemical safety report for the substances manufactured or imported in quantities of 10 tonnes or above. The technical dossier contains information like intrinsic properties of the substance, substance classification, use categories and instructions for safe use. The information requirements are different for each tonnage band (REACH regulation annexes VI to XI). The tonnage bands are: 1-10; 10-100; 100-1,000 and = 1,000 tonnes per year per manufacturer or importer. ECHA publishes substance information like classification and labelling; identified uses; physical and chemical properties; toxicological properties; and guidance on safe use on its website.
The chemical safety report documents the chemical safety assessment and is where the registrant provides information to all users of chemicals and for REACH processes such as authorisationIt 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 includes hazard evaluation and classification of the substance, together with the assessment about whether the substance is persistent and toxic to the environment or bio-accumulates in parts of the environment (PBT). The criteria for PBT and very persistent and very bio-accumulative (vPvB) substances are given in REACH Annex XIII.If the substance is classified as dangerous or as PBT or vPvB, then exposure scenarios, have to be built for each use.
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.
New safety data sheets and exposure scenarios
A safety data sheet (SDS) (or material safety data sheet (MSDS)) is a document that provides information about the properties and safe use of the chemical. It has to be delivered to the customer with the first supply of a dangerous substance or preparation. 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 Stateand it has to be consistent with the chemical safety report. A guide on the compilation of safety data sheets is provided in Annex II of the REACH regulation and in Commission Regulation (EU) No 1907/2006. More guidance is available at the ECHA website, for example for the use of safety data sheets (such as eGuide 1: Safety data sheets and exposure scenarios – Advice for recipients). Different SDS sections are listed in Table 1. An example of an exposure scenario can be found in Table 2. More exposure scenario examples are available on the ECHA Website 
Table 1: Content of the safety data sheet
|Sections||Relevant information to the downstream users in order to comply with REACH regulation|
|1. Identification of the substance/mixture and of the company/undertaking||Identified uses, registration number of the substance.|
|2. Hazard identification||Classification and labelling information: For substances according to both the Dangerous Substances Directive (DSD) and CLP regulation until June 2015. For mixtures according the DPD until June 2015 and after that according CLP regulation. Authorisation number if relevant.|
|3. Composition/information on ingredients||Hazards of the components of the preparation. Registration numbers of the components.|
|4. First aid measures||-|
|5. Fire-fighting measures||-|
|6. Accidental release measures||-|
|7. Handling and storage||-|
|8. Exposure controls/personal protection||Exposure limit values (DNELs and PNECs(1)) and 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 considerations||Information to be passed on to waste disposal organisation.|
|14. Transport information||-|
|15. Regulatory information||Information 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 information||Recommended restriction of use|
|Annex (if a chemical safety report is required)||Relevant exposure scenarios|
(1) Predicted No-Effect Concentration
Table 2: Exposure scenario example
|Exposure Scenario for metal pickling with sulfuric acid|
|Use descriptors||Industrial use, metal acid treatment SU3 Industrial uses: Uses of substances as such or in preparations at industrial sites SU15 Manufacture of fabricated metal products, except machinery and equipment PROC13 Treatment of articles by dipping and pouring|
|Contributing exposure scenarios||Worker scenario: Controlling worker exposure for treatment of articles by dipping and pouring PROC13 Environmental scenario: Controlling environmental exposure for treatment of articles by dipping and pouring ERC4|
|ES-1. Controlling worker exposure for treatment of articles by dipping and pouring|
|Product characteristics||Liquid mixture of sulfuric acid > 51% (18%), inhibitor (2%) and water (80%).|
|Amounts used||2 t/a|
|Frequency and duration of use||4 times or 2 hours per shift and 220 day/a.|
|Human factors not influenced by risk management||Exposure estimation based on measured data and qualitative assessment (ECETOC TRA).|
|Other given operational conditions affecting workers exposure||Temperature of the pickling bath is 35°-45°C Exposure estimation based on measured data.|
|Technical conditions and measures at process level (source) to prevent release||Indoor use. The pickling bath should be equipped with removable cover.|
|Technical conditions and measures to control dispersion from source towards the worker||Forced ventilation with air exchange rate of 8 1/h Equipment must be provided with LEV (Effectiveness 97% - Default value from ECETOC)|
|Organizational measures to prevent/limit releases, dispersion and exposure||Limit the access to the pickling area. Before carrying out the task, workers should have introduction training. Regular exposure assessment with occupational exposure measurements.|
|Conditions and measures related to personal protection||Acid resistant gloves, boots, clothes, and face shield against the splashes. During dilution use respiratory protection, filter E2-P3.|
|Additional good practice advise||The pickling bath should be kept closed during the pickling. Eating and drinking is prohibited during use of the substances/product. When diluting, always pour the acid into the water. Never add the water into the acid.|
|Workers exposure estimation and risk characterisation based on measured data and qualitative assessment (ECETOC TRA).|
|Assumptions made in exposure estimation||Frequency 2 hours/shift. Local exhaust ventilation is present. Personal protective equipments required for dermal exposure and during dilution respiratory protection is recommended.|
|Endpoint||Exposure concentration||DNEL||Risk characterisation ratio|
|Long-term inhalation systemic effect||1.120 mg/m3||2.0 mg/m3||0.56|
|Long-term inhalation local effect||1.120 mg/m3||1.5 mg/m3||0.75|
|Long-term dermal systemic||0.500 mg/kg/ bw/d||15 mg/kg/d||0.03|
|Long-term dermal local||not available **||not derived **||qualitative|
|Acute inhalation local||not applicable||not applicable||not applicable|
|Acute inhalation systemic||not applicable||not applicable||not applicable|
|Acute dermal local||not available **||not derived **||qualitative|
|Acute dermal systemic||not applicable||not applicable||not required|
|ES-2. Controlling environmental exposure for treatment of articles by dipping and pouring|
|Environmental factors not influenced by risk management||Receiving river flow rate > 15,000 m3/day|
|Other given operational conditions affecting environmental exposure||0.1% of acid is evaporated during the process 99.9 % of acid is neutralised and discharged to waste water Effluent flow rate: 3,000 m3/day|
|Technical onsite conditions and measures to reduce or limit discharges, air emissions and releases to soil.||Waste: Liquid waste must be collected on site Water: mixtures with low pH value should be neutralised before discharging to wastewater.|
|Organizational measures to prevent/limit releases from site||Leak detectors and spill containment should be used to prevent unexpected releases.|
|Conditions and measures related to external treatment of waste for disposal.||Closed loop supply system for large containers (> 200 l) Disposal - Dispose of this material and its container at hazardous or special waste collection point.|
|Environmental exposure estimation and risk characterisation|
|Exposure concentration||PNEC||Risk characterisation ratio|
|PEC fresh water||0.251 mh/l||0.4 mg/l||0.628|
|PEC fresh water sediment||1.01 mg/kg dw||1.6 mg/kg dw||0.631|
|PEC marine water||0.025 mg/l||0.04 mg/l||0.628|
|PEC marine water sediment||0.101 mg/kg dw||0.16 mg/kg dw||0.631|
|PEC soil||1.99E-05 mg/kg dw||no hazard for soil||qualitative|
|Environmental exposure estimation and risk characterisation men via environment|
|Exposure concentration||DNEL||Risk characterisation ratio|
|Totally daily dose||0.006 mg/kg/d||2.55 mg/kg/d||0.0024|
|PEC air||2.3E-05 mg/m3||0.815 mg/m3||2.82E-05|
(**) No measurement data available, qualitative assessment used based on operational conditions and risk management measures
Exposure scenarios are important tools for improving the safe use of chemicals in Europe. ECHA and several stakeholder organisations have developed a plan for improving the content and use of exposure scenarios during the years 2013-2018, the CSR/ES roadmap.
Also, the Exchange Network on Exposure Scenarios (ENES) has been established by ECHA together with the sector organisations Cefic, Concawe, Eurometaux, Fecc, A.I.S.E 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 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.
In addition, 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 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 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 through a support tool called REACH-navigator on the ECHA Website.
A third party can be any private or public organisation, which does not have obligations under REACH but can provide information to the Agency on substances. Typically, this group includes trade and industry organisations and non-governmental environmental organisations.
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 new 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 interest 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, will then decide 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. 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.
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 exist for the substances that are not registered under REACH and will not meet the criteria for authorisation.
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 existing restrictions are included in the REACH regulation (Annex XVII). All the existing restrictions based on the Marketing and Use Directive were carried over to Annex VII in REACH regulation.
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.
As mentioned above, the REACH regulation comes into force in several phases; see illustration below.
After June 2018, there will be only registered substances on the market, and any new substance has to be registered before placing it on the market. The authorisation and restriction procedures can be applied any time, also after 2018.
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.
It is important that companies check carefully the new safety data sheets as soon as they received one. A check-list for recipients of an extended SDS can be found in the CEFIC guidance on the extended safety data sheets.
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 useis 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.
Importers and manufacturers must notify hazardous substances if they are placing them on the market, on their own or in mixtures and irrespective of the tonnage.
All the downstream user obligations and roles are described in the ECHA guidance for downstream users. Many industry specific stakeholders have also published guidance for downstream users.
The European Parliament, ECHA, EU-OSHA and other concerned parties have initiated discussions how REACH could be adapted to deal with emerging risks such as risks from nanomaterials and endocrine disrupting compounds.
The European Parliament resolution of 24 April 2009 called specifically on the European Commission to review legislation to ensure that the particular features of nanomaterials are adequately addressed In particular with regard to REACH, it requested the Commission to evaluate the need to review REACH, concerning inter alia:
- simplified registration for nanomaterials manufactured or imported below one tonne;
- consideration of all nanomaterials as new substances;
- a chemical safety report with exposure assessment for all registered nanomaterials;
- notification requirements for all nanomaterials placed on the market on their own, in preparations or in articles.
A European Parliament ENVI (environment, public health and food safety) committee draft report calls for comprehensive criteria on what constitutes an endocrine disruptor to be applied horizontally across all EU legislation, and the introduction of ‘endocrine disruptor' as a regulatory hazard class.
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 new 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:
- 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.
REACH is a new concept in the European Union to control risks arising from the use of chemicals. Even though REACH replaces several chemical legislation acts, it does not interfere with the existing occupational health and safety requirements, but is complementary. It is expected rather that REACH will have a positive impact on the implementation of existing occupational safety and health (OSH) legislation.
REACH applies to chemical substances, substances in mixtures and substances in articles while OSH regulations deal with the use of chemicals at workplaces 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.
A guidance document prepared by the EC Advisory Committee on safety and health provides more detailed information on how REACH information can be used at workplaces and how the requirements for restricted use of certain substances fit together.
The EC´s Senior Labour Inspector´s Committee (SLIC) has developed a guidance for guidance for national labour inspectorates and their inspectors. It is not intended as guidance for manufacturers and users of chemicals, but focuses on the practical enforcement by providing guidance for inspectors on the requirements of REACH and the interfaces with the enforcement of requirements under the Chemical Agents Directive (CAD) and the Carcinogens and Mutagens Directive (CMD).
The goal in both regulations is to improve the level of safety and health at workplaces. 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 (including process related exposures, like welding fumes) and to conduct an overall risk assessment and implement adequate risk management measures. The risk management measures presented in the exposure scenarios should be taken into account when doing a risk assessment at workplaces and setting the preventive measures.
REACH introduces new 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 national 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. 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 DNEL values set well above or below OEL values. These discrepancies may create confusion in terms of legal compliance, risk management, and risk communication, although OSH regulations apply. 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.
Over the years, REACH is expected to bring more detailed information about the chemicals in use, which is expected to help make comparisons between different chemical products. Together these legislations will improve the knowledge about the chemicals in use.
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