ATP in the CLP Regulation

Overview of the adaptations to technical progress (ATPs) in the CLP Regulation and their implementation in Switzerland. 

13. ATP to the CLPR was published on 5 October 2018 as the Regulation (EU) 2018/1480.

Contents

Harmonised classification and labelling (Annex VI CLPR): As a result of the adaptation, 16 new substances have been added to Annex VI of the CLPR, and 18 existing entries have been amended.

The new additions include harmonised classifications for isoeugenol (CAS 97-54-1; Skin Sens 1A, 0.01%); 2-methyl-2H-isothiazol-3-one (CAS 2682-20-4; i.a. Acute Tox. 2 inhal., Skin Corr. 1B, Skin Sens. 1A, 15 ppm) and for diverse active substances (PSM, BP) with i.a. Aquatic Chronic 1.

The amendments include the harmonised classification of sodium hypochlorite solution … % active Cl (CAS 7681-52-9, new M-Factors and SCL 5% for EUH031); Vitamin D3/cholecalciferol (CAS 67-97-0, new ATE values for Acut. Tox 2); maleic anhydride (CAS 108-31-6, i.a. new Skin Sens 1A, 0.001%); reaction mass from 5-chloro-2-methyl-2H-isothiazol-3-one and 2-methyl-2H-isothiazol-3-one (3:1) (CAS 55965-84-9, i.a. now Skin Sens 1A, 15 ppm, Acut. Tox. 2 inhal a. dermal) as well as for numerous active substances (PSM, BP).

Additional information in the document:
«Umsetzung und Auswirkungen der 13. ATP» (PDF, 171 kB, 11.09.2019)
«Mise en oeuvre et impacts des modifications de la 13e APT» (PDF, 188 kB, 11.09.2019)
(available only in German and French)

Deadline in the EEA

  • Binding as of 01.05.2020

Implementation in Switzerland

  • in force since 01.07.2019 (revision Annex 2 no. 1 ChemO)
  • Binding as of 01.05.2020 (Annex 2 no. 9.2 ChemO)

12. ATP to the CLPR was published on 28 March 2019 as the Regulation (EU) 2019/521.

Contents

Changes to the UN-GHS (rev. 6th ed., 2015 and rev. 7th ed., 2017).). Most important points:

  • New hazard class for desensitised explosives (new Chapter 2.17)
  • New hazard category for pyrophoric gases in Chapter 2.2
  • Revised criteria for categorisation of flammable gases in cat. 1 (Chapter 2.2)
  • Introduction of cut-off values (general concentration cut-off value in Table 1.1) for STOT-SE 3 (1%) and Asp. Tox. (1%).
  • Adaptations for the standardisation and clarification of various health risks.
  • Various adaptations for standardising criteria, i.a. for explosives, STOT-SE, Asp. Tox, and Acute Aquatic.
  • Standardising the classification of aerosols based on tested mixtures (Bridging: 1.1.3.7. Aerosols)
  • Amendments for precautionary statements (P-statements) as a result of the current optimisation work at the UN level (deletions, consolidating existing P-statements).

Deadline in the EEA

Binding as of 17.10.2020

Implementation in Switzerland

in force since 01.07.2019 (Annex 2 no. 1 ChemO)

Binding as of 01.01.2021 (Annex 2 no. 9.1 ChemO)

11. ATP to the CLPR was published on 4 May 2018 as the Regulation (EU) 2018/669.

Contents

Identification of substances in Annex VI: All substances listed in Annex VI receive a binding translation in all official languages of the European Union. Previously the binding translations of substance names were only in the English language. The translation into all official languages corresponds to the wish of the Member States. Translations of substance names into the various languages were previously independently made by companies and by the authorities. Upon expiry of the transitional period the translated names from the Regulation (EU) 2018/669 shall be binding when labelling substances and preparations.

Important: Existing obligations for the declaration of substances on the label (Art. 10 para. 1 let. b ChemO in conjunction with Art. 18 no. 2 let. a and no. 3 let. b CLPR) and existing language requirements remain unaffected by the 11th ATP. The text on the label shall, however, take into account the official substance name according to Annex VI CLPR in the respective language used. Previously this was the case only for the English language.

Deadline in the EEA

  • Binding as of 01.12.2019

Implementation in Switzerland

  • in force since 01.12.2018 (Revision Annex 2 no. 1 ChemO)
  • Binding as of 01.06.2020. (Annex 2 no. 8 ChemO)

10. ATP to the CLPR was published on 5 May 2017 as the Regulation (EU) 2017/776.

Contents

Harmonised classification and labelling (Annex VI CLPR): As a result of the amendment, 24 new substances have been added to Annex VI of the CLPR, and 13 existing entries have been amended. In addition, as a result of the 10th ATP a new fundamental principle has been introduced. If a substance receives a new or modified harmonised classification for Acute Tox., then the identified value determined in the context of the assessment by the Committee for Risk Assessment (RAC) of ECHA shall be listed as the ATE value (Acute Toxicity Estimate) in Annex VI CLPR. This ATE value, like the substance-specific concentration limits (SCL) and the M-factors, is then part of the harmonised classification and is binding for the calculation of the acute toxicity of mixtures that comprise this substance (cf. entry for nicotine).

New additions include harmonised classifications for various cadmium compounds (Carc. 1B; Muta. 1B), for dibutyltin dilaurate (Repr. 1B), for various fragrances and flavouring substances (linalool, coriandrol, licareol: Skin. Sens. 1B) as well as for diverse active substances of biocidal products and plant protection products.

Modified harmonised classifications include that for nicotine (now: Acute Tox. 2 oral/dermal/inhalative) and for cyanamide (now: i.a. Carc. 2, Repr. 2, Acute Tox. 3 (oral/dermal), STOT RE 2). For some existing entries, new M-factors have been defined for their environmental classification (Acute aquatic 1 / Chronic aquatic 1), thereby resulting in lower concentration limits for the classification of their preparations. Some active substances for biocidal products are affected by this (e.g. Fipronil).

Deadline in the EEA

  • Binding as of 01.12.2018

Implementation in Switzerland

  • in force since 01.03.2018 (Revision Annex 2 no. 1 ChemO)
  • Binding as of 01.12.2018. (Annex 2 no. 7 ChemO)

9th ATP to the CLPR was published on 20 July 2016 as the Regulation (EU) 2016/1179.

Contents

As a result of the adaptation, 26 new substances have been added to Annex VI of the CLPR, and 22 existing entries have been amended. The 9th ATP also rescinds Table 3.2 in Annex VI with the harmonised classifications and labelling under the previous system (orange/black) with effect 1 June 2017.

The new additions include harmonised classification for the element lead in massive (Repr. 1A) and powder form (Repr. 1A, SCL 0.03), for dicyclohexyl phthalate (CAS 84-61-7, Repr. 1B), for certain glass microfibres (Carc. 1B or Carc. 2) and for numerous copper compounds classified as environmentally hazardous, Aquatic Acute 1 and Aquatic Chronic 1.

The amendments include the harmonised classification of bisphenol A (CAS 80-05-7, now Repr. 1B) and glutaraldehyde (CAS 111-30-8, now Acute Tox. 2 inhal.). For certain existing entries the concentration limits for classification as Repr. 1A or 1B have been lowered. The entries affected include diisobutyl phthalate (CAS 84-69-5), N-methyl-2-pyrrolidone (872-50-4) and many first and second generation anticoagulants. These anticoagulants have now been given a substance-specific limit of 0.003%.

Deadline in the EEA

  • Binding as of 01.03.2018

Implementation in Switzerland

  • In force since 01.12.2016 (revision Annex 2 no. 1 ChemO)
  • Binding as of 01.03.2018 (Annex 2 no. 6.2 ChemO)

8th ATP to the CLPR was published on 14 June 2016 as the Regulation (EU) No. 2016/918.

Contents

  • Changes to the UN-GHS (rev. 5th ed., 2013). Most important points:
  • New requirement for communicating hazards that may emanate from desensitised substances and mixtures (Chapter 2.1 UN-GHS)
  • Clarification of classification criteria for aerosols (Chapter 2.3)
  • Inclusion of a new methodology for classifying oxidising solids (Chapter 2.14)
  • Newly formulated classification and labelling criteria for the skin corrosion/irritation class of hazards
    (Chapter 3.2), including:
    -  Introduction of a new hazard category 1, used if there is not sufficient information available for classification
       in one of the sub-categories (1A, 1B and 1C)
    -  For substances and mixtures with an extreme pH (≤ 2 and ≥ 11.5), Category 1 applies if no other information
       is available.
    -  The procedure for classifying mixtures via components is being adapted to cover Category 1 components.
  • Newly formulated classification and labelling criteria for the serious eye damage/eye irritation class of hazards
  • As a result of ongoing optimisation on the UN level, comprehensive changes have been made to the precautionary statements. Around 20 precautionary statements and 10 combined precautionary statements are affected.
  • For mixtures the supplementary hazard statement EUH208 (“Contains <name of sensitising substance>. May produce an allergic reaction.”) may not be required if the mixture is already labelled with EUH204 (“Contains isocyanates. May produce an allergic reaction.”) or EUH205 (“Contains epoxy constituents. May produce an allergic reaction.”).

Deadline in the EEA

  • Binding for substances and mixtures as of 01.02.2018
  • Sales up to 31.01.2020 (substances and mixtures)

Implementation in Switzerland

  • In force since 01.12.2016 (Annex 2 no. 1 ChemO)
  • Binding as of 01.02.2018 / Sales up to 31.01.2020 (Annex 2 no. 6.2 ChemO)

7th ATP to the CLPR was published on 25 July 2015 as the Regulation Verordnung (EU) 2015/1221.

Contents

Harmonised classification and labelling (Annex VI CLPR): With the 7th ATP 20 substances were re-listed in Annex VI CLPR with a harmonised classification. The previously harmonised classification was changed for an additional 12 substances.

Harmonised classifications were re-listed for inter alia imidazole (CAS 288-32-4, Repr 1B) and diisohexyl phthalate DIHP (CAS 68515-50-4; Repr. 1B) and for numerous active substances for plant protection agents and biocidal products. Many of these active substances were re-classified as Aquatic Acute 1 and Aquatic Chronic 1.
The harmonised classification was changed for inter alia nitric acid (CAS 7697-37-2; new Ox. Liq. 2 and EUH071), gallium arsenide (CAS 1303-00-0, new additionally also Repr. 1B beside the existing Carc. 1B) as well as for various active substances for plant protection agents and biocidal products.

Deadline in the EEA

  • Binding as of 01.01.2017

Implementation in Switzerland

  • In force since 01.12.2015 (revision Annex 2 let. ChemO)
  • Binding as of 01.01.2017 (Annex 2 no. 5.2 ChemO 2015)

Corrigendum for the German version of the Ordinance 1272_2008
ABl. L 94 vom 10.4.2015, S.9 der Ausgabe in deutscher Sprache.

Contents

Corrigendum for the German version. Also concerns texts for P-statements and is therefore relevant for labelling.

Deadline in the EEA

  • Binding as of 10.10.2016 (based on 18 month deadline in Art. 30 para. 2 CLPO)

Implementation in Switzerland

  • In force since 01.12.2015 (revision Annex 2 no. 1 ChemO)
  • Binding as of 10.10. 2016 (Annex 2 no. 5.1 ChemO)

Liquid Caps: Published on 6 December 2014 as the Regulation Verordnung (EU) Nr. 1297/2014

Contents

Concerns liquid detergents in dissolvable packaging for private users (“Liquid Caps”). As a result of various accidents and feedback from toxicology centres, the Commission, in an emergency procedure, decreed stricter regulations for these products (technical characteristics of the packaging, child-proof design).

Deadline in the EEA

  • Binding since 01.06.2015
  • Sales up to 31.12.2015

Implementation in Switzerland

  • Binding as of 01.07.2015. (Annex 2 no. 1 ChemO). The industries concerned were informed beforehand in Dec. 2014.
  • Sales up to 31.12.2015 (Annex 2 no. 4.5 ChemO and Art. 93 para. 1 let. a ChemO for ‘Liquid Caps’ that were still labelled according to the previous system).

6th ATP to the CLPR was published on 6 June 2014 as the Regulation Verordnung (EU) Nr. 605/2014.

Contents

Harmonised classification and labelling (Annex VI CLPR): With the 6th ATP, 14 substances were re-listed with a harmonised classification in Annex VI, inter alia various active substances for plant protection agents / biocidal products. The previously harmonised classification was changed for an additional 9 substances, inter alia for styrene new Repr. 2) and for formaldehyde that was reclassified from Carc. Cat. 2 to Carc. Cat. 1B.

Deadline in the EEA

  • Originally 01.04.2015. Was extended to 01.01.2016 by modifying the 6th ATP Regulation (Verordnung (EU) Nr. 491/2015 of 23 March 2015)

Implementation in Switzerland

  • Binding since 01.01.2016 (Annex 2 no. 4.4 ChemO)

5th ATP to the CLPR was published on 3 October 2013 as the Regulation Verordnung (EU) Nr. 944/2013

Contents

  • Harmonised classification and labelling (Annex VI CLPR): Re-listing of harmonised classifications for a total of 22 substances (inter alia gallium arsenide, dihexyl phthalate, PFOA, diverse surfactants and active substances for plant protection agents / biocidal products) as well as modifications of previous harmonised classifications for 17 substances (inter alia chloroform, petroleum derivatives, active substances for PPA/BP).
  • New version for P210 (Annex IV of the CLPR) is actually a supplement to 4th ATP (timing is therefore identical to the 4th ATP)

Deadline in the EEA

  • Binding for pitch coal tar (EC 266-028-2) since 01.04.2016. For all other concerned substances since 01.01.2015.
  • New version P210 see deadlines in the EEA for the 4th ATP.

Implementation in Switzerland

  • Binding for pitch coal tar (EC 266-028-2) since 01.04.2016 (Annex 2 no. 4.3 ChemO).
  • For all other concerned substances since 01.02.2015 (rev. ClassificationO of 1.2.2014).
  • New version P210: see deadlines for implementing the 4th ATP in Switzerland.

4th ATP to the CLPR was published on 1 June 2013 as the Regulation Verordnung (EU) Nr. 487/2013

Contents

Changes to the UN-GHS (rev. 4th ed., 2011). Most important points:

  • Labelling simplification for “metal-corrosive” products that are not classified as Skin Corr. 1 and/or Eye Dam. 1 (Art. 23, Annex I no. 1.3.6)
  • Exemptions for labelling for inner packaging with a content of < 10 ml which are used for scientific R&D and quality control analyses (Art. I no. 1.5.2.4 and 1.5.2.5)
  • Classification of explosive substances (detail changes, chapter 2.1)
  • New definition and criteria for chemically unstable gases (chapter 2.2)
  • New criteria for aerosols (including non-inflammable aerosols, chapter 2.3); these changes have already been adopted in the modification to the aerosol guidelines (RL 2013/10/EU of 19 March 2013)
  • Changes to diverse P-statements (see Annex IV);

Deadline in the EEA

  • Binding for substances since 01.12.2014 and for mixtures since 01.06.2015.
  • Sales:
    Substances up to 30.11.2016
    Mixtures up to 31.05.2017

Implementation in Switzerland

  • Binding for substances and preparations since 01.07.2015 (Annex 2 no. 1 ChemO)
  • Sales:
    Substances: up to 30.11.2016 (Annex 2 no. 4.2 let. a ChemO)
    Preparations up to 31.05.2017 (Annex 2 no. 4.2 let. b ChemO)

3rd ATP to the CLPR was published on 11 July 2012 as the Regulation Verordnung (EU) Nr. 618/2012

Contents

Harmonised classification and labelling (Annex VI CLPR): 11 substances were re-listed with a harmonised classification and labelling in Annex VI. The existing classification/labelling was modified for 5 additional substances.

Deadline in the EEA

  • Binding since 01.12.2013

Implementation in Switzerland

  • Binding since 01.12.2013

2nd ATP to the CLPR was published on 30 March 2011 as the Regulation Verordnung (EU) Nr. 286/2011

Contents

Changes to the UN-GHS (rev. 3rd ed., 2009). Most important points:

  • New sub-categoried (1A/1B) for classifying sensitizing substances and mixtures
  • Lower concentration limits for the declaration of sensitizing substances (Cat. 1A) in mixtures
  • Combined hazard warnings for acute toxicity
  • Modifications in the classification criteria (data for chronic toxicity) in the hazard class "Aquatic Chronic Tox"
  • Introduction of the GHS hazard class “Damaging to the Ozone Layer” and the deletion of EUH059
  • Requirements were stated more precisely for the minimum unit of pictograms and for the labelling of small packages.

Deadline in the EEA

  • Binding for substances since 1.12.2014 and for mixtures since 1.6.2015
  • Sales:
    Substances: up to 01.12. 2014
    Mixtures up to 31.05.2017

Implementation in Switzerland

  • Binding for substances since 01.12.2012 and for preparations since 01.06.2015
  • Sales:
    Substances: up to 30.11.2014
    Preparations: up to 31.05.2017 (Annex 2 no. 4.1 ChemO)

1st ATP to the CLPR was published on 5 September 2009 as the Regulation Verordnung (EU) Nr. 790/2009

Contents

Harmonised classification and labelling (Annex VI CLPR):
The 1st ATP includes the last substances that were still officially classified according to the procedure of the Substance-RL 67/548/EC and had already been published beforehand as the 30 and 31st ATP to the Substance-RL; but because of the CLPR could no longer be adopted by the Member States.

Deadline in the EEA

  • Binding since 01.12.2010

Implementation in Switzerland

  • Binding since 01.12.2010

Last modification 17.09.2019

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