Actors in the supply chain: means all manufacturers and/or importers and/or downstream users and/or distributors in a supply chain (Article 3 (17) REACH).
Agency: means the European Chemicals Agency (ECHA), Helsinki, Finland, which is the central body established under the provisions of the REACH Regulation (Article 3 (18) REACH, Article 2 (23) CLP). The ECHA website, https://echa.europa.eu, was created for the implementation of all tasks of the Agency. The Agency deals with the registration, evaluation of chemicals, authorization and restrictions procedures, creation and publishing of a list of substances of very high concern – SVHC (Candidate List). The Agency publishes guidance, practical guides, brief guides, guidelines, information sheets, templates that are available from the ECHA website at https://echa.europa.eu/support/guidance. The ECHA website is also equipped with a special NAVIGATOR program to help define the company’s obligations under REACH and find appropriate guidelines to fulfil these obligations. The website works theoretically in all the languages of the Member States, but currently many issues are only in the English version.
|ECHA – the coordination and implementation center of REACH|
Article: means 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 (Article 3 (3) REACH, Article 2 (9) CLP); EXAMPLES: textiles, electronic chips, toys. If the articles contain substances from the candidate list, this results in additional obligations for enterprises, including DU and D. Manufacturers and importers of articles are obligated to register substances that are intended to be released from articles if their total content in articles exceeds 1 t/a, and to notify ECHA of substances on the candidate list if they are present in a concentration >0.1% w/w and the total amount of substance present in the products exceeds 1 t/a. It is possible to waive this obligation if the manufacturer or importer can exclude exposure of people or the environment (Article 7 (3) REACH). The suppliers of articles have the obligation to provide the recipients with information regarding substances on the candidate list contained in the articles in a concentration >0.1% w/w. (Article 33 (1) REACH), as well as consumers at their request (Article 33 (2) REACH) within 45 days of receipt of the request. This information should contain instructions for safe use of the article, or at least the name of the substance.
Authorization (one of the REACH processes): means the authorisation procedure – one of the regulatory tools of the REACH aiming to ban the use of substances of very high concern (SVHC) included in the Annex XIV of REACH, so as to substitute them by technically and economically feasible alternatives. This process concerns manufacturers, importers and downstream users of substances. Only representatives of foreign manufacturers can also apply for an authorisation. After placing the substance in Annex XIV, it can not be placed on the market or used after a given date (the final date), unless the use has been authorized or the use is exempt from the authorization requirement.
An application for an authorisation to continue or start using and placing substances included in the Authorisation List (Annex XIV of REACH) should be submitted to ECHA. The application may include uses of the substance by the applicant, downstream users or both. The purpose of this application is to show that no alternatives are immediately available, that the risks are controlled and the social and economic benefits of using substances outweigh the risks to human health or the environment. The application for authorization must be submitted before the last application date (LAD), set 18 months before the final date. The application is considered by the Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC). RAC and SEAC consider the application and issue a final opinion after public consultation, which is sent to the European Commission. After 3 months from receipt of the Committee’s opinion, the European Commission prepares a draft decision on the granting or refusal of authorization. It is possible to authorize the use of SVHC if the applicant can demonstrate that the risks arising from the use of the substance are adequately controlled or that the socio‑economic benefits outweigh the risks and that there are no suitable alternatives (see chapter 8.3).
Bridging methods (bridging principles): means the methods for classification of mixtures due to risks to human health or the environment, where the mixtures have not been tested, but there is sufficient data on similar tested mixtures and individual hazardous components (section 1.1.3 in Annex I of CLP and each section of Parts 3 and 4 of the same Annex). Bridging rules are not used to classify mixtures due to physical hazards. There are the following bridging principles: “Dilution, Batching, Concentration of highly hazardous mixtures, Interpolation within one toxicity category, Substantially similar mixtures, Review of classification where the composition of a mixture has changed, Aerosols”. Bridging methods and examples are described in the ECHA Guidance on the Application of the CLP Criteria [PDF][EN].
Bureau for Chemical Substances: means the central office of a government administration body that exercises statutory control over the placing on the market of chemical products. The office supports the Inspector for Chemical Substances in the implementation of his tasks.
Candidate List (Candidate List of Substances of Very High Concern – SVHC Substances): means an inventory of substances that have serious effects on human health or the environment, known as substances of very high concern The SVHC substances included in the Candidate List and then included in Annex XIV of REACH are subject to the pre-release authorization procedure. ECHA regularly submits its recommendations to the European Commission, which decides to include these substances in Annex XIV.
C&L Inventory: means the C&L database available on the ECHA website. The database contains information on the classification and labelling of notified and registered substances.
CAS number: number assigned to a particular chemical substance by the American organization Chemical Abstracts Service (CAS), allowing for the identification of substances. The CAS number is one of the most commonly used means of identifying chemical substances.
Chemical Safety Assessment (CSA): means a procedure that defines the conditions for the safe use of a substance at all stages of its existence. The assessment concerns producers and importers of all substances subject to registration, produced or imported in quantities of at least 10 t/a (Annex I of REACH). The CSA results are reported by the registrants in the chemical safety report (CSR), which is part of the registration dossier. Also, DU can make his own chemical safety assessment and document it in DU CSR. The CSA distinguishes three basic stages, although not all of them must occur throughout the entire procedure. The first stage is the hazard assessment, which consists of:
- Hazard assessment:
• for human health;
• resulting from physicochemical properties;
• for the environment;
• persistence, bioaccumulation and toxicity (PBT) and very persistent and very bioaccumulative (vPvB) assessments.
If, as a result of the four stages mentioned above, the registrant concludes that the substance meets the criteria for classification as dangerous or has been rated as belonging to the PBT or vPvB category, the chemical safety assessment shall comprise the following two additional stages.
- Exposure assessment, including the generation of one or more exposure scenarios (or, where appropriate, the determination of appropriate use and exposure categories) and exposure estimation.
- Risk characteristics.
Chemical safety assessment is not required:
- if the substance is contained in the mixture in concentration below the concentration limit for classification of mixtures (Annex I of REACH);
- if the substance is used to develop technology/research.
Chemical Safety Report (CSR): means a chemical safety report that documents the chemical safety assessment undertaken as part of the REACH registration process. The report is the key source from which the registrant provides information to all users of chemicals through the exposure scenarios. It also forms a basis for other REACH processes including substance evaluation, authorisation and restriction.
The chemical safety assessment is carried out to demonstrate that the risks from the 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, which is an essential component of the chemical safety report.
Development of CSR according to Annex I of REACH applies to:
- producers/importers of substances that are subject to the registration process, if they are manufactured or imported in an amount of at least 10 t/a.
- DU of substances for which exposure scenarios for a given direction of use (or use of his recipients) were not specified during the registration process.
- manufacturers, importers or downstream users of substances subject to the authorization system under REACH. This applies to situations where a substance is listed in Annex XIV of the REACH Regulation, and the company interested in further manufacture, import or use of this substance is forced to participate in the authorisation procedure, regardless of turnover. Depending on the role of the applicant applying for authorisation in the supply chain, the CSA / CSR are prepared by the producer, importer or downstream user, as part of the application for authorization according to the Annex I or Annex XII of REACH, or both of them.
- producers or importers of articles containing substances that are to be released from this article if such use has not yet been registered. A CSR report is required if the substance is contained in these articles in quantities exceeding 10 t/a.
CLP classification: means the classification of a substance/mixture in terms of hazards, based on the criteria specified in the CLP Regulation. Manufacturer, importer, and DU are required to classify the substances themselves if this substance does not have harmonized classification (Annex VI CLP), and it has dangerous properties. For substances for which there is a harmonized classification (Annex VI CLP), the harmonized hazard classification is legally binding for the classes and further variations in the types of hazards included in this entry. Classes and further variations in the types of hazards not included in the entry should be assessed and categorized on their own based on the criteria set out in the CLP Regulation. Self-classification aims to determine whether a chemical or a mixture poses a physical, health and/or environmental hazard and to adequately inform other actors in the supply chain about the hazards by appropriate labelling when the product is placed on the market The obligation does not depend on volume of the substance/mixture being produced/imported.
CLP Regulation: means Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging. The regulation introduces a new system for the classification and labelling of chemicals across the EU based on the Globally Harmonized System of the United Nations (UN GHS). The CLP Regulation is directly related to the REACH Regulation, establishes hazard statements, precautionary statements and pictograms providing information in the context of ensuring adequate protection of human health and the environment. The word CLP is an acronym from the first letters of the three main regulatory processes – classification, labelling, packaging of chemicals;
Collective control measures (technical control measures): means different types of ventilation systems that ensure proper interior ventilation, and thus improve the air parameters at work sites.
Community Customs Territory: covers the following countries: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Croatia, Denmark (except for Greenland and Faroe Islands), Estonia, Finland (including Aland Islands), France (including Monaco and overseas departments – French Guiana, Guadeloupe, Martinique and Réunion, without overseas Saint-Pierre and Miqelon and Mayotte), Greece, Spain (except Ceuta and Melilla), the Netherlands (European part), Ireland, Lithuania, Luxembourg, Latvia, Malta, Germany (except Busingen and Helgoland), Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, Hungary, Italy (except the Livogno and Campione d’Italia customs enclaves), United Kingdom of Great Britain and Northern Ireland (including Channel Islands and Isle of Man).
Note: The REACH system operates in the EEA and EFTA states, with the exception of Switzerland and according to Decision of the EEA Joint Committee No 25/2008 of 14 March 2008, the term “Member State (s)” used in the REACH Regulation should be understood to include, in addition to its meaning in the Regulation, the EFTA States.
Concentration limits: means the specific concentration limits assigned to a given substance and the generic concentration limits assigned to the hazard class/category, indicating a threshold at or above which the presence of the substance in another substance or mixture, whether as an identified impurity, additive or component, causes this substance or mixture to be classified as hazardous. The generic concentration limits are specified in Parts 3-5 of Annex I of the CLP. The specific concentration limits are given in Annex VI CLP (Table 3). For classification purposes, specific concentration limits take precedence over generic concentration limits, even when the specific concentration limit is higher than the generic concentration limit for a given hazard class and category.
In order to mention a substance as a mixture constituent in subsection 3.2 of the safety data sheet, the smallest concentration limit, specific or general for a given hazard class and category, shall be taken into account (table below).
List of hazard classes, hazard categories and concentration limits for which a substance shall be listed as a substance in a mixture in subsection 3.2 of SDS (29.5.2015 L 132/14 Official Journal of the European Union EN 1.1). However if the specific concentration limit is less than the concentration limit mentioned in the table below, the smaller one shall be used for the purposes of listing in section 3.2 of the safety data sheet.
Table 2. List of hazard classes, hazard categories and concentration limits due to which the substance is listed as a substance in a mixture in subsection 3.2
|Hazard Class and Category||Concentration limit (%)|
|Acute toxicity, category 1, 2 and 3||≥0.1|
|Acute toxicity, category 4||≥1|
|Skin corrosion/irritation, category 1, sub-categories 1A, 1B, 1C and category 2||≥1|
|Serious damage to eyes/eye irritation, category 1 and 2||≥1|
|Germ cell mutagenicity category 1A and 1B||≥0.1|
|Germ cell mutagenicity category 2||≥1|
|Carcinogenicity category 1A, 1B and 2||≥0.1|
|Reproductive toxicity, category 1A, 1B, 2 and effects on or via lactation||≥0.1|
|Specific target organ toxicity (STOT) – single exposure, category 1 and 2||≥1|
|Specific target organ toxicity (STOT) – repeated exposure, category 1 and 2||≥1|
|Hazardous to the aquatic environment – Acute, category 1||≥0.1|
|Hazardous to the aquatic environment – Chronic, category 1||≥0.1|
|Hazardous to the aquatic environment – Chronic, category 2, 3 and 4||≥1|
|Hazardous for the ozone layer||≥0.1|
If the specific concentration limit is less than the concentration limit mentioned in the table above, the smaller one shall be used for the purposes of listing in section 3.2 of the safety data sheet.
Consumer: means a natural person making a legal transaction with an entrepreneur which is not directly related to his business or professional activity, eg. the buyer of goods or services or user of any resources or goods. The consumer is not considered DU.
Descriptors of use: means a system of standardized description of uses developed by ECHA to facilitate chemical risk assessment and supply chain communication, containing 5 categories of descriptors: sector of use (SU), product category (PC), process category (PROC), environmental release category (ERC), article category (AC). They are used, e.g. in the substance registration dossier in the description of identified uses and in the title section of exposure scenarios. Application descriptors (PC, PROC, ERC, AC) can be used as input parameters to derive exposure estimates in modelling tools such as ECETOC-TRA (a free tool developed by the European Centre for Ecotoxicology and Toxicology of Chemicals – ECETOC for Targeted Risk Assessment – TRA) and EUSES.
Sector of use (SU): describes in which sector the substance is used. 3 main sectors: SU3: industrial; SU21: consumer; SU22: professional.
Process category (PROC): describes the application techniques or process type. Process category, operational conditions and risk management measures determine the level of occupational exposure for workers and professional users. Example: PROC7: Industrial spraying; PROC8a: Transfer of substance or mixture (charging/discharging) from/to vessels/large containers at dedicated facilities.
Product category (PC): describes the types of chemical products in which a substance is used. Product category, operational conditions and risk management measures primarily determine the level of consumer exposure. Examples: PC9a: Coatings and paints, thinners, paint removers; PC39: Cosmetics, personal care products.
Article Category (AC): describes the type of article (including plastics and dried mixture) in which the substance has been processed. Examples: AC2: Machinery, mechanical appliances, electrical/electronic articles; AC13: Plastic articles.
Environmental Release Category (ERC): describes the broad conditions of use from an environmental perspective, based on those characteristics that give a first indication of the potential release of the substance to the environment. Determines the level of environmental exposure. Examples: ERC2: Formulation of preparations; ERC6a: Industrial use resulting in the manufacture of another substance (use of intermediates); ERC8a: Wide dispersive indoor use of processing aids in open systems.
Sector of use (SU), product category (PC) and article category (AC) describe market sectors while PROCs and ERCs describe specific activities.
Distributor: means any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a mixture, for third Parties (Article 3 (14) REACH, Article 2 (20) CLP). The category of distributors also includes entities that change the brand name of a substance into a new one as long as they do not perform any activities referred to in REACH as “use”. EXAMPLES: a person who retails cleaning products, a detergent warehouse worker, a company selling disinfectants to a cleaning company, any entity that only stores and makes available substances and mixtures to third parties. If the distributor performs any activities specified as use, he is considered as DU.
|NOTE The DISTRIBUTOR category includes:· entities conducting retail trade;· entities conducting wholesale trade;· entities that change the brand name of a substance to a new one, as long as they do not perform any activities referred to in REACH as use.|
Downstream user: means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities (Article 3 (13) REACH, Article 2 (19) CLP). DU can be found in many industries, most of them are SMEs. The term “downstream user” in the context of the REACH and CLP regulations includes: a formulator, end user, manufacturer of articles, a filler, an industrial user, a professional user. The reimporter and importer are not DU but have DU rights and obligations if their non-Community supplier has appointed an ‘only representative’ for the purposes of acting as a registrant established in the Community. Distributors or consumers are not considered DU. EXAMPLE of downstream users:mobile cleaning companies, professional painters, construction companies, furniture companies, clothing companies, farmers, and users of lubricants for equipment, shoemakers, formulators of mixtures
|NOTE The DOWNSTREAM USER category includes: entities transferring a substance from one container to another (re-filler);manufacturers of mixtures e.g. manufacturers of paints, cosmetics, glue, windscreen washer fluids (formulators);manufacturers of articles e.g. manufacturers of screws, drywall, furniture;professional end-users of the substance in their own form, in a mixture, in an article (other than industrial activity), e.g. painters, varnishers, cleaners;industrial end-users of substances in their own form or in a mixture using them in an industrial process (these substances do not remain in the product), for example, entities cleaning the surface before galvanizing.|
Downstream User Chemical Safety Report (DU CSR): means a chemical safety report that documents the chemical safety assessment undertaken as part of the REACH registration process developed by downstream users, for substances for which no exposure scenarios for the given direction of use (or use of his recipients) were specified during the registration process. These are specific cases of unidentified or identified uses that the registrant considered undesirable (uses advised against). It also takes into account the situations when DU wants to keep information about his use confidential (Article 37 REACH). In such a situation, the DU, who is not required to register, prepares the DU CSR in accordance with Annex XII of REACH, and in each case when the guidelines refer to Annex I of REACH.
Note: DUs should be aware of the difficulties and problems they may encounter when preparing this complicated and costly report. Therefore, the DU should definitely avoid using the substance in a different way from the one indicated in the exposure scenario received from the supplier or ensure that the supplier includes its use in the exposure scenario. In order to avoid creating own DU CSR, a downstream user may:
- introduce the conditions set out in the exposure scenario provided;
- use a substituting substance / mixture that does not require the development of an exposure scenario;
- ask supplier to include his (DU) use in the CSR and recognize this use as identified;
- look for another supplier who will provide an exposure scenario covering his use.
|REMEMBER DU is not obliged to prepare a DU CSR if: • SDS for a given substance is not required (because, for example, it is not classified as hazardous); • in the case of substances for which CSR is not required at all (for example, as the registered tonnage is <10 t/a); • the concentration of the substance in the mixture being produced is lower than the lowest thresholds defined in Article 14 (2) REACH; • if the substance is used only for the purpose of research into products and the production process and their development. NOTE: if the substance is used in a total quantity <1t/a -– there is still an obligation to identify and apply appropriate risk control measures and to include this information, if necessary, in a safety data sheet to be provided to recipient.|
DU’s own use: means industrial or other professional use of a DU.
ECHA: means the European Chemicals Agency.
ECHA Guides: means publications, available on the ECHA website, at: https://echa.europa.eu/en/practical-guides, providing additional information and clarifications to legal provisions.
EC number: means a seven-digit number with the structure XXX-XXX-X assigned to a chemical in the European Inventory of Existing Chemical Substances (EINECS), the European List of Notified Chemical Substances (ELINCS) or in the list of chemical substances listed in the publication “No-longer polymers”.
EFTA States: means Iceland, Liechtenstein, Norway and Switzerland.
End user (an entity included in the DU category): means an entity that uses chemical products but does not supply them to further entities in the supply chain. This category includes industrial end users and professional end users.
European Economic Area, EEA: free trade area and the common market, covering the countries of the European Union and the European Free Trade Association (EFTA), with the exception of Switzerland.
Exposure scenario (ES): means a set of conditions, including operational conditions and risk management measures to adequately control the risks to human health and the environment. Exposure scenarios cover the entire life cycle of the substance, including formulation, industrial and professional end-use, consumer use and use in articles. ES may cover one specific process or use or several processes or uses as appropriate (Article 3 (37) REACH); ESs are developed for identified uses as a part of chemical safety assessment for substances with certain hazardous properties registered in quantities at least 10 tonnes per year per registrant. The format and content for an exposure scenario is not specified in REACH but stakeholders have agreed a common format and content. This includes the following sections:
- Title section;
- Conditions of use affecting exposure;
- Exposure estimation (this may include the risk characterization ratio); and
- Guidance to downstream users to evaluate if their use is within the boundaries of the exposure scenario.
ES is attached to the safety data sheet if the hazardous substance is registered in an amount of at least 10 t/a per registrant (extended safety data sheet).
Formulator (entity classified in the DU category): means a producer of mixtures that supplies other entities in the supply chain. EXAMPLES: paint manufacturer, tile adhesive manufacturer, laundry detergent manufacturer, person who uses the mixture to prepare other mixtures. The formulator is anyone who prepares the mixture when no chemical reaction takes place during mixing.
|REMEMBER FORMULATOR: refers to the producer of mixtures as well as aqueous and solvent solutions. A formulator purchasing substances outside the Community, e.g. in Switzerland or Japan, is considered an IMPORTER (he has the rights and obligations of an importer).|
Globally Harmonized System of Classification and Labelling of Chemicals GHS: classification and labelling system for substances and mixtures developed by the UN to harmonize the existing classification and labelling standards used in different countries. So far implemented in over 60 countries, including the whole European Union, by the CLP Regulation.
Harmonized classification and labelling (CLP): means a harmonized classification and labeling procedure that legally applies throughout the European Union, implemented by the CLP Regulation. The CLP classification is the implementation of the globally harmonized classification and labelling of chemicals (UN GHS) in the European Union. The current version of CLP is based on the seventh revised version of the GHS (UN) of 21.08.2017, but also uses the basic procedures found in DSD and DPD. The CLP classification in several hazard categories has more classes than the GHS classification, which increases the level of protection in comparison to the GHS classification.
Harmonized classifications are listed in Table 3 of Annex VI CLP (list of harmonized classification and labelling of hazardous substances) and should be used by all actors in the supply chain. Table 3 contains the index number of the chemical substance, International Chemical Identification, EC number, CAS number, classification elements (hazard classes, category codes and hazard statements codes), elements of the label (pictograms, signal word codes, hazard statement codes, supplementary hazard statement codes), specific concentration limits, M‑factors and notes.
Table 3. An example of a harmonized classification and labelling of substance (Table 3, Annex VI, CLP)
|Index No||International Chemical Identification||EC No||CAS No||Classification||Labelling||Specific Conc. Limits, M‑factors||Notes|
|Hazard Class and Category Code(s)||Hazard statement Code(s)||Pictogram, Signal Word Code(s)||Hazard statement Code(s)||Suppl. Hazard statement Code(s)|
|001-001-00-9||hydrogen||215-605-7||1333-74-0||Flam. Gas 1 Press. Gas||H220||GHS02 GHS04 Dgr||H220||U|
The meaning of the notes listed in the column Notes of Table 3 of Annex VI CLP is as follows:
Notes relating to the identification, classification and labelling of substances (Annex VI, 126.96.36.199.,CLP)
Note A: Without prejudice to Article 17(2), the name of the substance must appear on the label in the form of one of the designations given in Part 3. In Part 3, use is sometimes made of a general description such as „… compounds” or „… salts”. In this case, the supplier is required to state on the label the correct name, due account being taken of section 188.8.131.52.
Note B: Some substances (acids, bases, etc.) are placed on the market in aqueous solutions at various concentrations and, therefore, these solutions require different classification and labelling since the hazards vary at different concentrations. In Part 3 entries with Note B have a general designation of the following type: „nitric acid …%”. In this case the supplier must state the percentage concentration of the solution on the label. Unless otherwise stated, it is assumed that the percentage concentration is calculated on a weight/weight basis.
Note C: Some organic substances may be marketed either in a specific isomeric form or as a mixture of several isomers. In this case the supplier must state on the label whether the substance is a specific isomer or a mixture of isomers.
Note D: Certain substances which are susceptible to spontaneous polymerisation or decomposition are generally placed on the market in a stabilised form. It is in this form that they are listed in Part 3. However, such substances are sometimes placed on the market in a non-stabilised form. In this case, the supplier must state on the label the name of the substance followed by the words „non‑stabilised”.
Note F: This substance may contain a stabiliser. If the stabiliser changes the hazardous properties of the substance, as indicated by the classification in Part 3, classification and labelling should be provided in accordance with the rules for classification and labelling of hazardous mixtures.
Note G: This substance may be marketed in an explosive form in which case it must be evaluated using the appropriate test methods. The classification and labelling provided shall reflect the explosive properties.
Note J: The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0.1% w/w benzene (EINECS No 200-753-7). This note applies only to certain complex coal- and oil-derived substances in Part 3.
Note K: The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0.1% w/w 1,3-butadiene (EINECS No 203-450-8). If the substance is not classified as a carcinogen or mutagen, at least the precautionary statements (P102-)P210-P403 should apply. This note applies only to certain complex oil-derived substances in Part 3.
Note L: The classification as a carcinogen need not apply if it can be shown that the substance contains less than 3% DMSO extract as measured by IP 346 „Determination of polycyclic aromatics in unused lubricating base oils and asphaltene free petroleum fractions – Dimethyl sulphoxide extraction refractive index method”, Institute of Petroleum, London. This note applies only to certain complex oil-derived substances in Part 3.
Note M: The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0.005% w/w benzo[a]-pyrene (EINECS No 200-028-5). This note applies only to certain complex coal-derived substances in Part 3.
Note N: The classification as a carcinogen need not apply if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen. This note applies only to certain complex oil-derived substances in Part 3.
Note P: The classification as a carcinogen or mutagen need not apply if it can be shown that the substance contains less than 0.1% w/w benzene (EINECS No 200-753-7). When the substance is not classified as a carcinogen at least the precautionary statements (P102-)P260-P262-P301 + P310-P331 shall apply. This note applies only to certain complex oil-derived substances in Part 3.
Note Q: The classification as a carcinogen need not apply if it can be shown that the substance fulfils one of the following conditions:
- a short term biopersistence test by inhalation has shown that the fibres longer than 20 μm have a weighted half-life less than 10 days; or
- a short term biopersistence test by intratracheal instillation has shown that the fibres longer than 20 μm have a weighted halflife less than 40 days; or
- an appropriate intra-peritoneal test has shown no evidence of excess carcinogenicity; or
- absence of relevant pathogenicity or neoplastic changes in a suitable long term inhalation test.
Note R: The classification as a carcinogen need not apply to fibres with a length weighted geometric mean diameter less two standard geometric errors greater than 6 μm.
Note S: This substance may not require a label according to Article 17 (see Section 1.3 of Annex I) (Table 3).
Note T: This substance may be marketed in a form which does not have the physical hazards as indicated by the classification in the entry in Part 3. If the results of the relevant method or methods in accordance with Part 2 of Annex I of this Regulation show that the specific form of substance marketed does not exhibit this physical property or these physical hazards, the substance shall be classified in accordance with the result or results of this test or these tests. Relevant information, including reference to the relevant test method(s) shall be included in the safety data sheet.
Note U: When put on the market gases have to be classified as „Gases under pressure”, in one of the groups compressed gas, liquefied gas, refrigerated liquefied gas or dissolved gas. The group depends on the physical state in which the gas is packaged and therefore has to be assigned case by case. The following codes are assigned: Press. Gas (Comp.) Press. Gas (Liq.) Press. Gas (Ref. Liq.) Press. Gas (Diss.) Aerosols shall not be classified as gases under pressure (See Annex I, Part 2, Section 184.108.40.206, Note 2).
Notes relating to the classification and labelling of mixtures (Annex VI, 220.127.116.11.,CLP)
Note 1: The concentration stated or, in the absence of such concentrations, the generic concentrations set out in this Regulation are the percentages by weight of the metallic element calculated with reference to the total weight of the mixture.
Note 2: The concentration of isocyanate stated is the percentage by weight of the free monomer calculated with reference to the total weight of the mixture.
Note 3: The concentration stated is the percentage by weight of chromate ions dissolved in water calculated with reference to the total weight of the mixture.
Note 5: The concentration limits for gaseous mixtures are expressed as volume per volume percentage.
Note 7: Alloys containing nickel are classified for skin sensitisation when the release rate of 0.5 μg Ni/cm2/week, as measured by the European Standard reference test method EN 1811, is exceeded.
Note 8: The classification as a carcinogen need not apply if it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is less than 0.1%.
Note 9: The classification as a mutagen need not apply if it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is less than 1%.
Identified use: means the use of a substance on its own or in a mixture, or the use of a mixture that is intended by a participant (DU) of the supply chain, including his own use, or use of which he is notified in writing by direct DU (Article 3 (26) REACH). According to REACH, the identified use together with the conditions of safe use is included (manufacturer’s and importer’s obligation) in the registration dossier (CSR). In case of substances manufactured or imported in quantities of 10 t/a per registrant, exposure scenarios are developed for identified uses. The information on safe use conditions is provided for identified uses in the safety data sheet (section 1.2). If DU decides to develop his own CSR, identified uses and a description of conditions of safe use (risk management measures) must also be included in DU CSR.
Import: means the physical introduction into the customs territory of the Community (Article 3 (10) REACH, Article 2 (16) CLP). Import is considered as “placing on the market” (Article 3 (12) REACH, Article 2 (18) CLP).
Importer when “only representative” is appointed: acts as DU (he has DU rights and obligations) if the supplier from outside the Community has nominated an only representative for the purpose of acting as a registrant established in the Community. EXAMPLE: if an entity established in Poland produces paints with the ingredients imported from the USA and an American manufacturer has appointed the “only representative” established in the EU, in this case the “only representative” becomes an importer and the paint producer in Poland becomes DU.
INCI name: means the name according to the International Nomenclature of Cosmetic Ingredients – a naming system designed to unify the naming of cosmetic ingredients. At present, according to European Union law, cosmetic products must have a description of ingredients in all Member States;
Individual control measures: means measures, with which the employer is obliged to provide employees in order to protect the health and life of employees, eg. safety shoes, protective clothing, respiratory protection equipment.
Industrial end user (an entity included in the DU category): means an entity that uses chemical products at an industrial plant but does not supply them to other entities in the supply chain. EXAMPLES: entities using surface cleaners prior to electroplating or users of intermediates in chemical synthesis.
Intended release: means intended release of the substance from the article. EXAMPLE: the perfumed toy is a product with the intended release of the substance, because the fragrances contained in the toy are released in order to increase its attractiveness.
Intermediate: means any substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (e.g. “synthesis”) (Article 3 (15) REACH). Different types of intermediates are defined under REACH: non-isolated intermediates, isolated intermediates including on-site (non transported) isolated intermediates, transported isolated intermediates.
M-factor: means the coefficient used to classify a mixture by calculation with respect to the concentrations of a constituent substance classified as hazardous to the aquatic environment, acute exposure category 1 or chronic exposure category 1. The M factor is set by manufacturers, importers and downstream users. The M‑factor is not determined for substances for which the M-factor is given in the list of harmonized classification and labelling (Annex VI of the CLP regulation 1272/2008).
Mixture (chemical mixture, formerly preparation): means a mixture or solution composed of two or more substances (Article 3 (2) REACH) (Article 2 (8) CLP). EXAMPLES : paints, adhesives, cosmetics, lubricants, detergents, aqueous and solvent solutions.
National helpdesks: means information centers present in each Member State, created on the basis of Article 124 REACH, which obliges Member States to set up national information centers to provide manufacturers, importers, downstream users and any other interested parties with advice regarding their liability and obligations under the Regulation. The list of National helpdesks is available on the ECHA website here. National information centers are to help enterprises, especially SMEs.
NAVIGATOR: means a tool to help define the obligations under REACH, available on the ECHA website, at: https://echa.europa.eu/pl/support/guidance-on-reach-and-clp-implementation/identify-your-obligations/navigator.
Non-isolated intermediates: means substances that appear between two consecutive chemical reactions and that are not removed from the system, except sampling.
Only representative: means a natural or legal person established in Europe designated by enterprises established outside the EEA who assume the roles and responsibilities of importers in order to meet the requirements of the REACH Regulation. The company for which the only representative imports substances / mixtures / products is not DU, but has the rights and duties of DU. Only representatives may represent several non-EEA suppliers, but they must keep their information separately. A non-EEA company must inform the importer(s) in the same supply chain about appointing an only representative. These importers are then considered as downstream users under REACH.
|REMEMBER The ‘only representative’ takes over the importer’s obligations related to the registration and the company for which he imports products from outside the EEA takes over the rights and obligations of the downstream user.|
Placing on the market: means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market (Article 3 (12) REACH, Article 2 (18) CLP).
Product with intended release of substance: means an article whose one function is deliberate release from articles. EXAMPLE: a perfumed toy is a product with the intended release of a substance, increasing its attractiveness.
Professional end user (an entity included in the DU category): means an entity that uses chemical products outside of an industrial plant, in a workshop, at the customer’s premises or in an education or healthcare facility, but not provide them to other entities in the supply chain. EXAMPLES: construction companies and mobile cleaning companies, professional painters, floor covering contractors, farmers and users of lubricants for devices such as chain saws, refinishers, laundry workers, smokers in the boiler room.
REACH-IT: means REACH-IT is the central IT system that supports Industry, Member State competent authorities and the European Chemicals Agency to securely submit, process and manage data and dossiers. These three parties each have access to specific functions of REACH-IT which they can use to fulfill their requirements under the REACH and CLP regulations. REACH-IT also provides a secure communication channel between these three parties to help them coordinate the processing and evaluation of data and dossiers.
REACH Regulation: means Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 aimed at ensuring a high level of protection of human health and the environment through registration, evaluation, authorization and restriction of chemicals. The word REACH is an acronym from the first letters of the regulation’s title – registration, evaluation, authorization and restriction of chemicals.
Re-brander (entity included in the Distributor category): means an entity placing its own brand on a product produced by another entity. It is a subcategory of distributors in the supply chain. However, if the re-brander, in addition to storing and changing the brand, performs activities referred to in REACH as „use”, eg. transferring a substance/mixture from one container to another, it is classified as a downstream user category and has DU responsibilities.
Recipient of an article: means an industrial or professional user, or a distributor, being supplied with an article but does not include consumers (Article 3 (35) REACH).
Recipient of a substance or a preparation: means a downstream user or a distributor being supplied with a substance or a preparation (Article 3 (34) REACH).
Re-filler (entity included in the DU category): means a refillable unit that transfers substances or mixtures from one container to another, usually when changing the packaging or trade name; EXAMPLES: a service provider or entrepreneur conducting a refill business.
Registrant: means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance (Article 3 (7) REACH). The registrant prepares most of the documents required under REACH. The registrant has the right to obtain from the DU information on the appropriateness of the risk management measures (RMM) proposed, in particular when proposed RMM are inappropriate.
Registrant’s own use: means an industrial or professional use by the registrant (Article 3 (25) REACH).
Registration (one of the REACH processes): means obligatory registration of all chemical substances (with the exception of those specified in Article 2 of REACH) on its own, as part of a mixture or in an article (article from which the substance is released under normal or reasonably foreseeable conditions of use). Registration applies to substances manufactured or imported in quantities of at least 1 t/a per one producer/importer. Registration is carried out before placing the substance on the market, by submitting a registration dossier at ECHA via the REACH-IT portal.
In the case of producers or importers of an article, the obligation to register a substance applies if the substance in the article has not previously been registered for such use.
|REMEMBER Mixtures and articles are not subject to registration, only chemical substances contained in them.|
|REMEMBER TWO RULES:1. NO DATA – NO MARKET, which means that an unregistered substance can not be authorised to be placed on the market;2. ONE SUBSTANCE – ONE REGISTRATION, which means that manufacturers and importers of the same substance must jointly submit registration dossier.|
Registration dossier: means the documentation submitted to ECHA in REACH-IT by the registrant of a chemical substance (manufacturer or importer), which consists of:
- technical documentation, containing:
• general information on the registrant;
• substance identification;
• information on the production and uses of the substance;
• classification and labelling of the substance;
• guidelines for safe use;
• information on exposure.
The scope of technical documentation depends on the tonnage of the substance produced/registered (ANNEX VII-X REACH ).
- chemical safety report (CSR) is required in the case of a substance manufactured or imported in an amount of at least 10 t/a per the registrant.
Registration number: means a unique number generated by the IT system of the REACH-IT when the registration dossier for a given substance is complete. ECHA will forward the registration number and the date of registration to the registrant(s) concerned without delay. From that moment on, the registration number assigned should be used in any further correspondence relating to the registration procedure (Article 20 (3) REACH).
Reimporter (entity acting as DU, but not included in the DU category): means an importer of a substance on its own or in a mixture which was originally produced in the Community and was registered by another entity in the same supply chain. The Reimporter has the rights and duties of DU in the supply chain.
Restriction (one of four main REACH procedure): means regulatory measures to protect human health and the environment from unacceptable risks posed by chemicals. Restrictions may limit or ban the manufacture, placing on the market or use of a substance (Annex XVII of REACH). A restriction can apply to any substance on its own, in a mixture or in an article, including those that do not require registration. Restrictions setting out conditions for the placing on the market of substances apply to both domestic production and imports. Community-wide restrictions apply to substances incorporated into Annex XVII of REACH to protect human health and the environment against unacceptable risks associated with these chemicals. Information on restrictions is provided in section XV of the safety data sheet, according to REACH, and if there is no obligation to provide a safety data sheet, the supplier is obliged to provide the recipient with:
• details of each application of the restriction;
• information necessary to identify and apply equivalent risk management measures;
• the registration numbers of the substances concerned by the above information.
Annex XVII to REACH Regulation on EUR-Lex: see latest consolidated version.
Annex XVII on ECHA website: https://echa.europa.eu/en/substances-restricted-under-reach
Retailer (an entity included in the Distributor category): means an entity that stores and places on the market substances, mixtures or articles, making them available to end-users and/or professional users in retail sales. It is a subcategory of distributors in the supply chain. However, if in addition to storing and changing the brand the retailer performs other activities referred to in REACH as „use”, eg. transferring a substance/mixture from one container to another, he falls into the category of downstream user and bears DU duties. For example, filling or mixing paints in a warehouse is considered as use under REACH, so by doing such activities he becomes DU.
Risk Assessment Committee (RAC): means the Committee that issues opinions on substance risks for human health and the environment on behalf of ECHA under the REACH processes (restriction and authorization) and CLP (harmonized classification and labelling). Final decisions are taken by the European Commission (Article 70 REACH).
Risk control measures (risk management measures -RMM): means measures and procedures that reduce the risk of exposure to an acceptable level. The term „risk control” is used because it is often impossible to completely eliminate the risk. The risk control process requires paying attention to all regulatory and international standards that may be required from the employer. Occupational Safety and Health regulations may require specific controls of specific hazards depending on the legal regulations. Typical risk control measures include individual and collective control measures, good health and safety practices, chemical safety training, compliance with safety rules, and the implementation of automated equipment. The registrant informs downstream users about appropriate risk management measures for any particular use of the substance. The person responsible for chemical safety in a company is required to provide employees with RMM.
More info on RMM you can find at Guidance on information requirements and chemical safety assessment Chapter R.13: Risk management measures and operational conditions https://echa.europa.eu/documents/10162/13632/information_requirements_r13_en.pdf
Safety data sheet, SDS or material safety data sheet, MSDS: means a document prepared in accordance with Annex II to REACH. The safety data sheet is an integral part of the system created under REACH.
The information provided in the SDS is divided into 16 sections defined in Annex II to REACH.
THE OBLIGATION TO POSSESS AND PROVIDE SDS down the supply chain concerns:
• substances or mixtures that meet the criteria for classification as hazardous under the CLP Regulation;
• substances which are persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) in accordance with the criteria contained in Annex XIII of REACH; or
• substances that are for any other reason on the candidate list of substances subject to the authorization procedure in accordance with Article 59 (1) REACH (Article 31 (1) REACH).
• mixtures that, although not meeting the criteria for classification as posing hazard under CLP, require the development of a safety data sheet and make it available on request (Article 31 (3) REACH) and comments on Tables 3.4.6, 3.6.2, 3.7.2, 3.8.3 and 3.9.4 from Annex I to CLP.
SDS is not legally required for substance which is not classified as hazardous (see above), however, it is a good practice for suppliers to provide SDS for all chemical substances/mixtures.
|REMEMBER There is an obligation to have and to provide a safety data sheet of substances / mixtures that meet the above criteria regardless of the volume of their production, import or application. Whenever a safety data sheet is required, the DU must provide his users in the safety data sheet with information on the hazards and conditions of safe use and appropriate risk management advice.|
Safety data sheet extended, extended SDS: means the Safety Data Sheet extended with exposure scenarios for the identified uses that they contain. Applies to hazardous substances registered in quantities of 10 tonnes or more per year. It contains a summary of key information obtained from the chemical safety assessment carried out in accordance with REACH.
Safety data sheet „on request”: means a safety data sheet which the supplier is required to provide to the professional occupant at his request (Article 59 (2) CLP, Article 31 (3) REACH) if the mixture does not meet the criteria for classification as hazardous in accordance with CLP title I and CLP title II but includes:
a) in concentrations of at least 1% by weight separately in the case of mixtures not present in the form of gas and at least 0.2% vol. in the case of mixtures in the form of gas, a substance that poses a risk to human health or the environment; or
b) in concentrations of at least 0.1% by weight separately in the case of mixtures which are not in the form of gas, at least one substance that is carcinogenic category 2 or toxic for reproduction category 1A, 1B and 2, has skin sensitization, category 1, or is a respiratory sensitiser, category 1, or affects lactation or is harmful to breastfed babies or is persistent, bioaccumulating and toxic (PBT) according to the criteria set out in Annex XIII REACH or very persistent and very bioaccumulative (vPvB) according to the criteria set out in in Annex XIII REACH or which has been placed on the list drawn up in accordance with Article 59 (1) REACH for reasons other than those referred to in point a); or
c) a substance for which maximum occupational exposure limits have been determined in the Community.
SEVESO: means legal regulations concerning the control of major-accident hazards related to hazardous substances, known as Seveso II Directives.
Small and medium-sized enterprises (SMEs): means small and medium-sized enterprises as defined in the Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (Article 3 (36) REACH).
Socio-Economic Analysis Committee (SEAC): means the Committee that issues opinions on behalf of ECHA on the socio-economic impact of possible legislative actions on chemicals under the REACH processes (restrictions, authorization). Final decisions are taken by the European Commission (Article 71 REACH).
Substance: means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition (Article 3 (1) REACH, Article 2 (7) CLP).
Substances CMR (carcinogenic, mutagenic or toxic to reproduction): means a group of compounds classified as carcinogenic, mutagenic or toxic to reproduction, classified in categories 1 or 2 (Annex I CLP).
Substances PBT (persistent, bioaccumulative and toxic): means persistent, bioaccumulative and toxic substances. It is a group of compounds with high resistance to degradation caused by abiotic and biotic factors, with a high level of bioaccumulation and high toxicity. The criteria for the identification of PBT substances are presented in Annex XIII of REACH.
Substances PPORD (Product and Process Oriented Research and Development): means substances manufactured, imported or used in product and production process research and development.
Substances SR&D (Scientific Research and Development): means substances manufactured, imported or used in scientific research and development. These substances are exempt from the authorization procedures and restrictions that normally apply even for substances manufactured or imported in quantities below 1 t/a.
Substances SVHC (substances of very high concern): means a group of substances of very high concern which includes:
- CMR substances meeting the criteria for classification in hazard class:
- carcinogenicity category 1A or 1B,
- germ cell mutagenicity category 1A or 1B,
- reproductive toxicity category 1A or 1B,
- PBT substances – persistent, bioaccumulative, toxic substances (PBT), in accordance with the criteria in Annex XIII of REACH;
- vPvB substances – very persistent and very bioaccumulative substances, in accordance with the criteria in Annex XIII of REACH;
- other substances such as endocrine disrupters or persistent, toxic, bioaccumulative substances or very persistent substances that are very bioaccumulative and do not meet the above criteria, for which there is scientific evidence of likely serious effects on human health or to the environment giving cause for concern equivalent to the concerns raised by other substances mentioned above and which are identified in each case individually in accordance with the procedure set out in Article 59 REACH.
Substances UVCB (Chemical Substances of Unknown or Variable Composition, Complex Reaction Products and Biological Material): means substances of unknown or variable composition, reaction complex products or biological materials.
Substances vPvB (very persistent, very bioaccumulative): means very persistent and very bioaccumulative substances. It is a group of compounds with very high resistance to degradation caused by abiotic and biotic factors, and with a very high level of bioaccumulation. The criteria for identifying vPvB substances are presented in Annex XIII of REACH.
Summation method: the method used to classify mixtures in terms of hazards to the aquatic environment. The calculation must take into account the joint contribution of all substances classified as acute 1, chronic 1, chronic 2 and chronic 3. In order to classify the hazards that the mixture poses for the aquatic environment, the „relevant ingredients” of the mixture are considered, which are identified taking into account two factors: 1. the classification of the ingredient, 2. its concentration in the mixture.
Supplier of an article: means any producer or importer of an article, distributor or other actor in the supply chain placing an article on the market (Article 3 (33) REACH).
Supplier of a substance or a mixture: means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture, or a mixture (Article 3 (32) REACH, Article 2 (26) CLP).
Unidentified use: means a use that is not included in the CSR and exposure scenarios prepared by the supplier (manufacturer, importer) and for which safe use conditions have not been developed, eg. safe operating conditions and the necessary risk control measures were not provided in the exposure scenarios. According to Article 37 REACH, each DU has the right to inform his supplier of the not included use so as to become an identified use. Alternatively, DU can prepare his own chemical safety report – DU CSR, which will take into account his use. Alternatively, DU may also adapt his activities to the conditions of use specified in the exposure scenarios provided by the supplier. Another option is to look for another supplier who will provide an exposure scenario covering his use. If the DU develops his own chemical safety assessment (CSA) and then document it in the DU CSR for uses not covered in the exposure scenarios prepared by the supplier, the CSA must be made available on request, but it need not be sent to ECHA. The only obligation for downstream user in this situation is to notify ECHA for which use the DU has carried out the chemical safety assessment and who is the supplier of the substance.
Use: means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation (Article 3 (24) REACH, Article 2 (25) CLP). The description of uses is a key condition for the chemical safety assessment in the registration documentation. It also plays an important role for DUs, in particular as regards verification whether their use has been included in the exposure scenarios provided in the supply chain, and consequently whether safe working conditions (risk management measures) have been defined for these uses. Use, for example, paint preparation, which consists of several activities, including handling of raw materials and filling of dishes, mixing and filling process, cleaning of dishes.
Uses advised against: means the use for which the registrant did not specify the conditions of safe use in the exposure scenarios. This is a use that the registrant is aware of (because, for example, he has learned about it from DU or has such knowledge). The registrant may consider the use to be unsafe after a chemical safety assessment or discourage such use for precautionary reasons without even assessing it. Information on uses advised against is listed in section 1.2 of the safety data sheet.