FAQ

 
In this section you will find a list of frequently asked questions and answers concerning REACH, CLP and relation regulations that you might find useful in your operations.
The FAQs section is based on the questions asked frequently by our customers, and also includes questions about some very specific REACH issues that are in our opinion of interest for the general public. The database is regularly updated.

Topics:




  • 1. REACH: general issues
    • 1.1. What is REACH and where can I find detail information?

      REACH is an abbreviation for Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals that became effective on June 1, 2007.
      The purpose of the regulation is to ensure effective functioning of the common market of chemical substances within the European Community, the protection of human health and environment against undesired effects of chemicals. As a regulation, REACH is superior to other legal regulations concerning the same subject and covers various issues of trade, production and use of chemicals within the EU. The new system of control of chemical substances aims at ensuring that no later than 2020 only such chemicals (on their own, in a preparation or in an article) are used whose properties are known and in a manner that is not detrimental to human health or environment.
      REACH is not applicable to waste, the carriage of dangerous materials, non-isolated intermediates, substances in transit (in a free zone) and radioactive substances.
      Detailed information about the REACH regulation can be found at this website:
      www.echa.europa.eu
      http://cefic.be/en/REACH-implementation.html
    • 1.2. What is ECHA and its role?

      ECHA stands for the European Chemicals Agency which is the lead coordination and implementation center for the REACH regulation. The Agency is located in Helsinki, Finland, and manages the registration, evaluation, authorization and restriction processes for chemical substances. Furthermore, it is to ensure that all these processes are consistent throughout the European Union. It creates and administers databases necessary for the functioning of the system, develops software tools and manuals, and provides professional assistance to the Commission and EU Member States. More information can be found at www.echa.europa.eu
  • 2. Registration
    • 2.1. What is subject to registration?

      Chemical substances manufactured in or imported to the EU by a single registrant in quantities equal to or higher than 1 ton per year. The limit of 1 ton is applicable to substances that are placed on the market on their own, in preparations or in articles (if they are released during the lifecycle of the article, including their disposal). Limited registration is required for isolated intermediates manufactures in quantities equal to or less than 1 ton per year.

      The REACH regulation allows for the following substances to be placed on the market without registration:
      - medicinal product for human or veterinary use;
      - food or feeding stuffs (including food additive in foodstuffs and feeding stuffs, flavoring);
      - polymers;
      - biocidal products and substances in plant protection;
      - substances defined in Annex IV of the REACH regulation (e.g. water, sugar, limestone;
      - substances specified in Annex V of the REACH regulation (e.g. substances which result from a chemical reaction upon end use, substances occurring in nature, if they are not classified as dangerous);
      - re-imported substances which were registered under the REACH regulation before export;
      - substances produced as a result of recycling, e.g. from preparations or articles; but only such substances which were registered earlier;
      - substances used in applied research and development.

      Note: If the manufactured/imported substance is in quantities less than 1 ton per year, other obligations may be applicable under the REACH regulation. Such obligations are subject to the nature of the substance (whether dangerous or not) and your role in the supply chain.
    • 2.2. Who is required to register?

      Under the REACH regulation, registration is submitted by a natural or legal person within the Community, if they
      - produce a substance within the EU;
      - import a substance to the EU;
      - are an only representative appointed by a non-Community manufacturer under Article 8 (see Question 6).
      If you are an OQEMA customer you are not required to submit registration because it is our duty to supply you with products in compliance with the REACH regulation. Within the definitions of the REACH regulation our customers are either downstream users or distributors.
    • 2.3. What is pre-registration and its benefits?

      Pre-registration is a process of preliminary registration that took place between June 1 and December 1, 2008. At this phase, all the manufacturers and importers of the so-called phase-in substances for which registration is required (see Question 3) had a chance to submit brief information to ECHA on substances they intended to register. Organizations which made such pre-registration may now benefit from extended registration deadlines (see Question 6). Without pre-registration, each substance for which registration is required must be registered without delay before it is manufactured or placed on the EU market. This obligation applies from June 1, 2008.
      Late pre-registration is possible after December 1, 2008, if:
      - it is a phase-in substance (see Question 6) that was manufactured or imported to the EU for the first time after this date in quantities equal to or higher than 1 ton per year (on their own, in a preparation or an article with intended release);
      - no more than 6 months elapsed since the first manufacturing/import of 1 ton;
      - no less than 1 year remains before the applicable extended deadline for full registration is to expire.
    • 2.4. What is mean with extended registration deadlines?

      If pre-registration was made, the manufacturer/importer may benefit from the following extended deadlines for full registration:
      - November 30, 2010 from CMR ≥ 1 t/y, R 50-53 ≥ 100 t/y and other substances ≥ 1000 t/y;
      - May 31, 2010 for other substances ≥ 100 t/y;
      - May 31, 2018 for other substances ≥ 1 t/y.
      After the expiration of these deadlines, all pre-registered substances must be registered in compliance with the REACH regulation, however, before that it may be placed on the market as per the regulations currently in effect.
    • 2.5. How do I know that a substances was pre-registered or registered?

      All the information you need to know can be found on our website! In the Basic Information section you can download our statement to the pre-registration process as well as a list of our products which are exempted from the obligation to register. You will be informed about registration by way of safety data sheets or in a different way case of substances for which no safety data sheet is required but must still be registered under the REACH regulation.
  • 3. GHS and CLP
    • 3.1. What are GHS and CLP regulation?

      For twelve years, the United Nations have been developing unified criteria for classification and labeling. Its main objectives are to facilitate international trade and at the same time to protect human health and environment. The result of this work is the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).
      For the purpose of accession to the GHS, on December 16, 2008, the European Parliament and the Commission issued Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures known as the CLP Regulation. The CLP regulation became effective on January 20, 2009 and should progressively replace the currently effective EU regulations on chemical substances (67/548/EEC) and chemical preparations (1999/45/EC). Both regulations are to be annulled by as of June 1, 2010.

      The CLP regulation is not applicable to:
      - - radioactive substances;
      substances and mixtures which are subject to customs supervision;
      - non-isolated intermediates;
      substances and mixtures for scientific research and development;
      - waste;
      - - in the finished state intended for the final user, medicinal and veterinary medicinal products, cosmetic products, food or feeding stuff.
    • 3.2. What are the deadlines for the new classification and labeling under the CLP regulation?

      The CLP regulation stipulates two binding deadlines:
      1.1. classification and labeling of substances (under the CLP criteria) is obligatory as of November 30, 2010;
      1.2. classification and labeling of substances (under the CLP criteria) is obligatory as of May 31, 2015.
      However, it is possible to classify and label chemicals in compliance with the CLP regulation even before these deadlines. Until May 31, 2015, the safety data sheets are to use classification under the CLP regulation together with the classification under Directives 67/548/EEC and 1999/45/EC.
      A two-year extended deadline is applicable to substances and mixtures placed on the market before the binding deadlines for re-labeling and re-packaging of goods (i.e. for substances until December 1, 2012, and for mixtures until June 1, 2017).
  • 4. Safety data sheets
    • 4.1. How does the REACH and CLP regulations affect safety data sheets?

      As per Articles 31 and 32, the supplier is required to provide customers with information about supplied products in a standardized format, provided that the scope of such information is subject to the level of dangerousness of the product. Dangerous chemicals are supplied to customers with safety data sheets in the form corresponding to Annex II of the REACH regulation. Gradual changes will be implemented in safety data sheets as the implementation of REACH and CLP regulations proceeds.
      The first significant changes were the change in order of Chapters 2 and 3, specification of an email address to the person responsible for compilation of a given safety data sheet and different names of individual chapters. Thus, OQEMA updated all its safety data sheets for dangerous substances. Updated safety data sheets can be downloaded in the Catalogue section.
      As of November 30, 2010, in relation to the effectiveness of the CLP regulation, safety data sheets will be updated according to the new classification and labeling instructions (see Questions 3.1 and 3.2).
      Safety data sheets for substances the registration of which under the REACH regulation was conditioned by the issue of a chemical safety report will have exposure scenarios as a separate annex.
    • 4.2. What are exposure scenarios and their purpose?

      Exposure scenarios are enclosures to chemical safety reports the compilation of which is required for registration of substances in quantities of ≥ 10 tons per year per registrant. The aim of assessing chemical safety is to define the conditions of safe use of the substance during the entire lifecycle. Exposure scenarios are the key tool of planning safe use of substances and are attached as an annex to safety data sheets of registered substances. If the exposure scenario for a given substance or preparation does not cover the manner of use by you or your customers, you will probably have to carry out your own assessment.
      However, as downstream users you have the right to notify the supplier about your manner of use of a given substance no later than 12 months before the end of a relevant registration deadline (i.e. before December 1, 2009 for the registration deadline falling on November 30, 2010, etc.) for the supplier to be able to incorporate such use into the registration documents and list it as a so-called identified use.
      Please, let us know using the contact form, if you receive a safety data sheet with an exposure scenario which does not cover your manner of use of the substance.
  • 5. Restrictions and authorizations
    • 5.1. What are SVHC?

      Substances of very high concern (SVHC) are those which give rise to a high level of concern and as per Article 59 are included in a candidate list for eventual inclusion in Annex XIV of the REACH regulation concerning the authorization of manufacture, placement on the market and use of some chemical substances. The current SVHC can be found at: http://echa.europa.eu/chem_data/authorisation_process/candidate_list_en.asp
      Substances are included in the candidate list at the proposal of the Commission or EU Member States, if they meet any of the following criteria:
      - carcinogenic category 1 or 2;
      - mutagenic category 1 or 2;
      - toxic for reproduction category 1 and 2;
      - PBT and vPvB;
      - other dangerous substances (e.g. as those having endocrine disrupting properties or for which there is scientific evidence of probable serious effects to human health or the environment).
    • 5.2. Do OQEMA products contain any SVHC?

      The table below shows all our products that contain SVHC substances at volume over 0.1% in mass. 

      Product nameTypeSVHC substanceCASEINECSContent
      Boric acidsubstanceBoric acid10043-35-3233-139-2> 99 %
      Dimethylformamidesubstance N,N- dimethylformamide 68-12-2 200-679-5 > 99% 
      Disodium tetraborate 5H20substanceDisodium tetraborate 5H2012179-04-3215-540-4> 99 %
      Disodium tetraborate 10H20substanceDisodium tetraborate 10H201303-96-4215-540-4> 99 %
      Lipaton SB 29Y41mixturenonylphenol, branched, EO68412-54-4 ≤ 3,4%
      Lipaton SB 33Y10mixturenonylphenol, branched, EO68412-54-4 ≤ 2 %
      Lipaton SB 5813mixture4-nonylphenol, branched, EO127087-87-0 ≤ 2 %
      Morpholine substance with impurity 2-methoxyethanol 109-86-4 203-713-7 < 0,5% 
      N-methylpyrrolidone śubstance 1-Methyl-2-pyrrolidone872-50-4  212-828-1  > 99 % 
      Slovafol 906substance with impurity 4-nonylphenol, branched 84852-15-3 284-325-5 ≤  1% 
      Slovafol 906substance4-nonylphenol, branched, EO127087-87-0 ≤ 100%
      Slovafol 909substance with impurity  4-nonylphenol, branched 84852-15-3 284-325-5 ≤ 0,1%
      Slovafol 909substance4-nonylphenol, branched, EO127087-87-0 ≤ 100%
      Slovamix TZmixture4-nonylphenol, branched, EO127087-87-0 35 %
      Sodium perborate tetrahydratesubstanceSodium perborate (tetrahydrate)37244-98-7234-390-0 >96%
    • 5.3. Is authorization under the REACH regulation already required for any substance?

      Yes. The table below shows all our products that contain any substance which is subject to the authorization. 
      Product nameSubstance CAS EINECS Content Latest application date Sunset date 
      Chromium trioxideChromium trioxide1333-82-0215-607-8> 99 %2016-03-212017-09-21
      Extir A 3000 AEHBCDD 3194-55-6 221-695-9 

      ≤ 2,5%

      2014-01-21 2015-07-21 
      Extir A 5000 AEHBCDD 3194-55-6 221-695-9 

      ≤ 2,5%  

      2014-01-21 2015-07-21 
      Koplen F 0814HBCDD 3194-55-6 221-695-9 

      ≤  1%

      2014-01-21 2015-07-21 
      Koplen F 1020HBCDD3194-55-6  221-695-9  ≤  1% 2014-01-21 2015-07-21  
      Potassium dichromatePotassium dichromate7778-50-9231-906-6> 99 %2016-03-212017-09-21
      SCONAPOR F 038 HBCDD 3194-55-6 221-695-9 > 0,1% 2014-01-21 2015-07-21 
      SCONAPOR F 138 HBCDD 3194-55-6 221-695-9 > 0,1% 2014-01-21 2015-07-21 
      SCONAPOR F 238 HBCDD 3194-55-6 221-695-9 > 0,1% 2014-01-21 2015-07-21 
      SCONAPOR F 338 HBCDD 3194-55-6 221-695-9 > 0,1% 2014-01-21 2015-07-21 
      SCONAPOR F 438 HBCDD 3194-55-6 221-695-9 > 0,1% 2014-01-21 2015-07-21 
      Styropor F 215 HBCDD 3194-55-6  221-695-9  ≤  1%  2014-01-21  2015-07-21  
      Styropor F 315 HBCDD 3194-55-6  221-695-9  ≤  1%  2014-01-21  2015-07-21  
      TrichloroethyleneTrichloroethylene79-01-6201-167-4> 99 %2014-10-212016-04-21
    • The REACH Regulation requires that ECHA identifies from the "Candidate List" (see Question 5.1) priority substances to be included in Annex XIV of REACH (the "Authorization List") and then recommends Annex XIV entries for these substances to the European Commission. ECHA submitted its first recommendation to the European Commission on 1 June 2009. Proposals for other priority substances will be made at least every other year.

      The proposals are available at: 
      http://echa.europa.eu/chem_data/authorisation_process/annex_xiv_rec_en.asp 
    • 5.4. Does any restriction under the REACH regulation apply to any substance?

      Yes. Regulation (EC) No 552/2009 of June 22, 2009 amended Annex XVII of the REACH regulation concerning restrictions on the manufacturing, placement on the market and use of some chemical substances, preparations (mixtures) and articles.
  • 6. Definitions

    SIEF = Substance Information Exchange For that associates potential registrants of the same substance and should facilitate their mutual communication and coordination of dossier compilation. The aim of the forum is to prevent redundant testing on vertebrates and to reach an agreement in classification of the substance. No binding rules apply to the use of SEIF, and it is at the discretion of each association how they are going to proceed with mutual communication. Each SIEF appoints a Lead Registrant who submits a joint registration for a given substance.
    Only representative = as per Article 8 non-Community manufacturers may appoint their only representative in the Community to represent them in the registration process and communication with ECHA.
    CMR = substances with carcinogenic, mutagenic or toxic for reproduction properties - restrictions are expected to apply for such substances and they may be candidates for inclusion in Annex XIV (substances subject to authorization).
    PBT = persistent, bioaccumulative and toxic substances - a new classification which once again may be linked to certain restrictions.
    vPvB = very persistent and very bioaccumulative substances - see the definition above.
    Phase-in substances = substances which meet at least one of the following criteria:
    - is listed in the EINECS;
    - was manufactured in the Community at least once in the 15 years before June 1, 2007 but not placed on the market;
    - was classified as a no-longer polymer.