Commission Regulation (EU) 2020/1149 of 3 August 2020 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards diisocyanates (Text with EEA relevance)
Date: 2020-08-03
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: building materials, chemical product, dangerous substance, health risk, market approval, marketing standard, occupational safety, product safety








L_2020252EN.01002401.xml










4.8.2020   


EN


Official Journal of the European Union


L 252/24








            COMMISSION REGULATION (EU) 2020/1149
of 3 August 2020
         
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards diisocyanates
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (1), and in particular Article 68(1) thereof,

Whereas:







(1)


Diisocyanates have a harmonised classification as a respiratory sensitiser category 1 and as a skin sensitiser category 1 according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2). Diisocyanates are used as chemical building blocks in a wide range of sectors and applications, in particular in foams, sealants and coatings, inter alia, throughout the Union.












(2)


On 6 October 2016, Germany submitted to the European Chemicals Agency (‘the Agency’) a dossier (3) pursuant to Article 69(4) of Regulation (EC) No 1907/2006 (‘the Annex XV dossier’), in order to initiate the restriction procedure set out in Articles 69 to 73 of that Regulation. The Annex XV dossier indicated that respiratory sensitisation, due to both dermal and inhalation exposure to diisocyanates, leads to occupational asthma in workers, which has been identified as a significant occupational health problem in the Union. The annual number of new occupational diseases caused by diisocyanates (estimated to be more than 5 000 cases) is considered unacceptably high. The Annex XV dossier demonstrated that action on a Union-wide basis is necessary and proposed to restrict the industrial and professional use, as well as the placing on the market, of diisocyanates on their own, and as constituent of other substances and in mixtures.












(3)


The restriction proposed in the Annex XV dossier aims to limit the use of diisocyanates in industrial and professional applications to those cases where a combination of technical and organisational measures are implemented, and a minimum standardised training course has been followed. Information on how to get access to the course should be communicated throughout the supply chain and it should be the responsibility of the operators placing these substances and mixtures on the market to ensure that training courses are available to the recipients of such substances or mixtures.












(4)


On 5 December 2017, the Agency’s Committee for Risk Assessment (‘RAC’) adopted its opinion (4) concluding that the proposed restriction, as modified by RAC, is the most appropriate Union-wide measure to address the identified risks arising from exposure to these substances in terms of effectiveness in reducing those risks. Moreover, it considered that the implementation of the modified proposed restriction would reduce as well the number of diisocyanate-related cases of dermatitis.












(5)


RAC concluded that appropriate training is a basic necessity, and that every worker handling diisocyanates should have a sufficient knowledge of the hazards of these substances and an awareness of the risks related with their uses, as well as sufficient knowledge of good working practices and appropriate risk management measures (RMMs), including the correct use of appropriate personal protective equipment. RAC notes that particular training measures are needed to raise the awareness about the importance of health protection by means of appropriate RMMs and safe handling practices.












(6)


RAC considered that the cut-off limit of 0,1 % by weight, set for diisocyanates in a substance or in a mixture, corresponds to the lowest concentration limit existing for specific diisocyanates classified as respiratory sensitisers category 1. RAC also agreed with the dossier submitter that the implementation of an indicative or binding occupational exposure limit would not be sufficient to reduce the number of occupational asthma cases to a level as low as possible, since currently, no threshold is known for the sensitising effect of diisocyanates.












(7)


On 15 March 2018, the Agency’s Committee for Socio-Economic Analysis (‘SEAC’) adopted its opinion (5), in which it confirmed RAC’s conclusion that, in view of its socioeconomic benefits and costs, the proposed restriction is the most appropriate Union-wide measure to address the identified risks. Furthermore, SEAC concluded that the proposed restriction is affordable for the affected supply chains.












(8)


SEAC recommended a 48 month deferral of application of the restriction in order to provide sufficient time to all actors for the full implementation of the restriction requirements.












(9)


The Agency’s Forum for Exchange of Information on Enforcement, referred to in Article 76(1)(f) of Regulation (EC) No 1907/2006, was consulted on the RAC and SEAC opinions concerning the proposed restriction and its recommendations have been taken into account.












(10)


On 9 May 2018, the Agency submitted the opinions of RAC and SEAC to the Commission. Based on those opinions, the Commission concludes that an unacceptable risk to human health arises from the use or placing on the market of diisocyanates, on their own, as a constituent of other substances and in mixtures. The Commission considers that those risks need to be addressed on a Union-wide basis.












(11)


Taking into account the Annex XV dossier as well as the opinions of RAC and SEAC, the Commission considers that a minimum requirement for training should be provided to industrial and professional users without prejudice to stricter national obligations in the Member States. The Commission also considers that information of this requirement should be included in the packaging.












(12)


For the purpose of possible future revisions of the current restriction, Member States should report to the Commission in accordance with Article 117(1) of Regulation (EC) No 1907/2006 any established training requirements, the number of reported cases on occupational asthma and occupational respiratory and dermal disease, any national occupational exposure levels and information on enforcement activities.












(13)


Without prejudice to Union occupational safety and health legislation, in particular the Council Directive 98/24/EC on chemical agents (6), this restriction is intended to enhance the employers’ capacity to achieve a higher level of risk control. Small and medium sized enterprises will benefit from this act, which will further enhance the implementation of the present occupational safety and health requirements by providing diisocyanates-specific training programmes throughout the supply chain.












(14)


Economic operators should be granted a period of sufficient length to adapt to the new requirements. A transition period of 3 years is appropriate to allow the concerned workforce to perform the required training.












(15)


Regulation (EC) No 1907/2006 should therefore be amended accordingly.












(16)


The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,





HAS ADOPTED THIS REGULATION:



Article 1
Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to this Regulation.


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 3 August 2020.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 396, 30.12.2006, p. 1.

(2)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

(3)  https://echa.europa.eu/documents/10162/63c411e5-cf0f-dc5e-ff83-1e8de7e4e282

(4)  https://echa.europa.eu/documents/10162/737bceac-35c3-77fb-ba7a-0e417a81aa4a

(5)  https://echa.europa.eu/documents/10162/d6794aa4-8e3a-6780-d079-77237244f5f9

(6)  Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (OJ L 131, 5.5.1998, p. 11).




ANNEX
In Annex XVII to Regulation (EC) No 1907/2006, the following entry is added:







‘74. Diisocyanates, O = C=N-R-N = C=O, with R an aliphatic or aromatic hydrocarbon unit of unspecified length








1.


Shall not be used as substances on their own, as a constituent in other substances or in mixtures for industrial and professional use(s) after 24 August 2023, unless:






(a)


the concentration of diisocyanates individually and in combination is less than 0,1 % by weight, or










(b)


the employer or self-employed ensures that industrial or professional user(s) have successfully completed training on the safe use of diisocyanates prior to the use of the substance(s) or mixture(s).














2.


Shall not be placed on the market as substances on their own, as a constituent in other substances or in mixtures for industrial and professional use(s) after 24 February 2022, unless:






(a)


the concentration of diisocyanates individually and in combination is less than 0,1 % by weight, or










(b)


the supplier ensures that the recipient of the substance(s) or mixture(s) is provided with information on the requirements referred to in point (b) of paragraph 1 and the following statement is placed on the packaging, in a manner that is visibly distinct from the rest of the label information: “As from 24 August 2023 adequate training is required before industrial or professional use”.














3.


For the purpose of this entry “industrial and professional user(s)” means any worker or self-employed worker handling diisocyanates on their own, as a constituent in other substances or in mixtures for industrial and professional use(s) or supervising these tasks.










4.


The training referred to in point (b) of paragraph 1 shall include the instructions for the control of dermal and inhalation exposure to diisocyanates at the workplace without prejudice to any national occupational exposure limit value or other appropriate risk management measures at national level. Such training shall be conducted by an expert on occupational safety and health with competence acquired by relevant vocational training. That training shall cover as a minimum:






(a)


the training elements in point (a) of paragraph 5 for all industrial and professional use(s).










(b)


the training elements in points (a) and (b) of paragraph 5 for the following uses:






—


handling open mixtures at ambient temperature (including foam tunnels);










—


spraying in a ventilated booth;










—


application by roller;










—


application by brush;










—


application by dipping and pouring;










—


mechanical post treatment (e.g. cutting) of not fully cured articles which are not warm anymore;










—


cleaning and waste;










—


any other uses with similar exposure through the dermal and/or inhalation route;














(c)


the training elements in points (a), (b) and (c) of paragraph 5 for the following uses:






—


handling incompletely cured articles (e.g. freshly cured, still warm);










—


foundry applications;










—


maintenance and repair that needs access to equipment;










—


open handling of warm or hot formulations (> 45 °C);










—


spraying in open air, with limited or only natural ventilation (includes large industry working halls) and spraying with high energy (e.g. foams, elastomers);










—


and any other uses with similar exposure through the dermal and/or inhalation route.


















5.


Training elements:






(a)


general training, including on-line training, on:






—


chemistry of diisocyanates;










—


toxicity hazards (including acute toxicity);










—


exposure to diisocyanates;










—


occupational exposure limit values;










—


how sensitisation can develop;










—


odour as indication of hazard;










—


importance of volatility for risk;










—


viscosity, temperature, and molecular weight of diisocyanates;










—


personal hygiene;










—


personal protective equipment needed, including practical instructions for its correct use and its limitations;










—


risk of dermal contact and inhalation exposure;










—


risk in relation to application process used;










—


skin and inhalation protection scheme;










—


ventilation;










—


cleaning, leakages, maintenance;










—


discarding empty packaging;










—


protection of bystanders;










—


identification of critical handling stages;










—


specific national code systems (if applicable);










—


behaviour-based safety;










—


certification or documented proof that training has been successfully completed














(b)


intermediate level training, including on-line training, on:






—


additional behaviour-based aspects;










—


maintenance;










—


management of change;










—


evaluation of existing safety instructions;










—


risk in relation to application process used;










—


certification or documented proof that training has been successfully completed














(c)


advanced training, including on-line training, on:






—


any additional certification needed for the specific uses covered;










—


spraying outside a spraying booth;










—


open handling of hot or warm formulations (> 45 °C);










—


certification or documented proof that training has been successfully completed


















6.


The training shall comply with the provisions set by the Member State in which the industrial or professional user(s) operate. Member States may implement or continue to apply their own national requirements for the use of the substance(s) or mixture(s), as long as the minimum requirements set out in paragraphs 4 and 5 are met.










7.


The supplier referred to in point (b) of paragraph 2 shall ensure that the recipient is provided with training material and courses pursuant to paragraphs 4 and 5 in the official language(s) of the Member State(s) where the substance(s) or mixture(s) are supplied. The training shall take into consideration the specificity of the products supplied, including composition, packaging, and design.










8.


The employer or self-employed shall document the successful completion of the training referred to in paragraphs 4 and 5. The training shall be renewed at least every five years.










9.


Member States shall include in their reports pursuant to Article 117(1) the following information:






(a)


any established training requirements and other risk management measures related to the industrial and professional uses of diisocyanates foreseen in national law;










(b)


the number of cases of reported and recognised occupational asthma and occupational respiratory and dermal diseases in relation to diisocyanates;










(c)


national exposure limits for diisocyanates, if there are any;










(d)


information about enforcement activities related to this restriction.














10.


This restriction shall apply without prejudice to other Union legislation on the protection of safety and health of workers at the workplace.’