Commission Regulation (EU) 2021/2045 of 23 November 2021 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance)
Grade B
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Address https://gelex.eu/eli/EU/regulation/2021/2045@2021-11-23/en
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, and in particular Articles 58 and 131 thereof,
Whereas:
(1) The substances bis(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) are listed in entries 4 to 7 of Annex XIV to Regulation (EC) No 1907/2006 because they meet the criteria set out in point (c) of Article 57 of that Regulation. In accordance with Article 59 of Regulation (EC) No 1907/2006, DEHP has subsequently been additionally identified as meeting the criteria set out in point (f) Article 57 of that Regulation, namely as having endocrine disrupting properties for which there is scientific evidence of probable serious effects to the environment. All the four substances have further been identified in accordance with Article 59 of Regulation (EC) No 1907/2006 as meeting the criteria set out in point (f) Article 57 of that Regulation, namely as having endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health. In accordance with Article 58(3) of Regulation (EC) No 1907/2006, on 10 July 2019 the European Chemicals Agency (the Agency) recommended the elements referred to in Article 58(1) of that Regulation to be specified for each of those substances.
(2) The inclusion of intrinsic properties relating to hazards for the environment in the entry for DEHP in Annex XIV to Regulation (EC) No 1907/2006, means that the uses of that substance in medical devices falling within the scope of Council Directive 90/385/EEC, Council Directive 93/42/EEC or Directive 98/79/EC of the European Parliament and of the Council are subject to authorisation requirement as the second subparagraph of Article 60(2) of Regulation (EC) No 1907/2006 provides that the Commission shall not consider risks to human health only arising from those uses. As regards the uses of that substance in food contact materials within the scope of Regulation (EC) No 1935/2004 of the European Parliament and of the Council, the inclusion of intrinsic properties relating to hazards for the environment means that those uses are subject to authorisation requirement as Article 56(5) of Regulation (EC) No 1907/2006 no longer applies to them.
(3) By including in the entries of DEHP, BBP, DBP and DIBP intrinsic properties referred to in point (f) of Article 57 of Regulation (EC) No 1907/2006, the concentration limit applicable to the presence of those substances in mixtures for the purposes of the exemption set out in Article 56(6) of that Regulation becomes 0,1 % weight by weight.
(4) Article 58(1)(e) in conjunction with Article 58(2) of Regulation (EC) No 1907/2006 provides for the possibility of exemptions of uses or categories of uses in cases where specific Union legislation imposes minimum requirements relating to the protection of human health or the environment ensuring proper control of the risks. In accordance with the information currently available, it is not appropriate to set exemptions based on those provisions.
(5) Commission Regulation (EU) No 143/2011 exempted from the authorisation requirement the use of DEHP, BBP and DBP in the immediate packaging of medicinal products covered by Regulation (EC) No 726/2004 of the European Parliament and of the Council, Directive 2001/82/EC of the European Parliament and of the Council and/or Directive 2001/83/EC of the European Parliament and of the Council. The judgment of the Court of Justice of 13 July 2017 in Case C-651/15 P, VECCO and Others v. Commission, provided clarifications on certain aspects of Article 58(2) of Regulation (EC) No 1907/2006 for granting an exemption from the authorisation requirement. The Commission has re-assessed the exemption set out in Annex XIV to that Regulation and has concluded that it does not meet the conditions in Article 58(2). In particular, in the light of that judgement, Regulation (EC) No 726/2004, and Directives 2001/82/EC and 2001/83/EC do not constitute existing specific Union legislation imposing minimum requirements relating to the protection of human health or the environment for the use of DEHP, BBP and DBP in immediate packaging of medicinal products within the meaning of Article 58(2) of Regulation No 1907/2006 since they do not contain provisions specific to those substances imposing such requirements. Furthermore, Regulation (EC) No 726/2004 and Directives 2001/82/EC and 2001/83/EC lay down requirements related to the protection of human health only, while, as regards DEHP, intrinsic properties relating to hazards for the environment have been included in the entry for that substance in Annex XIV to Regulation (EC) No 1907/2006. Those exemptions are therefore not justified and should be deleted.
(6) For the uses of DEHP, BBP, DBP and DIBP that will no longer be exempted from the authorisation requirement, it is appropriate to indicate the dates referred to in point (i) of Article 58(1)(c) of Regulation (EC) No 1907/2006, taking into account the Agency’s recommendation of 10 July 2019 and its capacity to handle applications for authorisations. As regards uses of DEHP in medical devices, the dates should also take into account the transitional provisions for the application of Regulations (EU) 2017/745 and (EU) 2017/746 of the European Parliament and of the Council.
(7) For each of the uses of DEHP, BBP, DBP and DIBP that will no longer be exempted from the authorisation requirement, there are no reasons for which the date referred to in point (ii) of Article 58(1)(c) of Regulation (EC) No 1907/2006 should be set earlier than 18 months than the date referred to in Article point (i) 58(1)(c) of that Regulation.
(8) During the public consultation conducted by the Agency on its draft recommendation, no specific comments were submitted with regard to possible exemptions for product and process orientated research and development. As there is no information justifying the need for such an exemption, the exemption was not considered.
(9) As the available information on the uses of the substances concerned by this Regulation is limited, it is not appropriate to set review periods at this stage, pursuant to point (d) of Article 58(1) of Regulation (EC) No 1907/2006.
(10) Regulation (EC) No 1907/2006 should therefore be amended accordingly.
(11) The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 133 of Regulation (EC) No 1907/2006,
HAS ADOPTED THIS REGULATION:
Article 1
Annex XIV 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, 23 November 2021. For the Commission The President Ursula von der Leyen
ANNEX
ANNEX
Entries 4 to 7 in the table in Annex XIV to Regulation (EC) No 1907/2006 are replaced by the following entries: Entry Nr Substance Intrinsic property(ies) referred to in Article 57 Transitional arrangements Exempted (categories of) uses Review periods Latest application date(1) Sunset date(2) 4. Bis(2-ethylhexyl) phthalate (DEHP) EC No 204-211-0 CAS No 117-81-7 Toxic for reproduction (category 1B) Endocrine disrupting properties (Article 57(f) – human health) Endocrine disrupting properties (Article 57(f) – environment) - - 5. Benzyl butyl phthalate (BBP) EC No 201-622-7 CAS No 85-68-7 Toxic for reproduction (category 1B) Endocrine disrupting properties (Article 57(f) – human health) - - 6. Dibutyl phthalate (DBP) EC No 201-557-4 CAS No 84-74-2 Toxic for reproduction (category 1B) Endocrine disrupting properties (Article 57(f) – human health) - - 7. Diisobutyl phthalate (DIBP) EC No 201-553-2 CAS No 84-69-5 Toxic for reproduction (category 1B) Endocrine disrupting properties (Article 57(f) – human health) - -
(a) 21 August 2013 (*)
(b) By way of derogation from point (a): 14 June 2023 for uses in:
food contact materials within the scope of Regulation (EC) No 1935/2004;
immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;
mixtures containing DEHP at or above 0,1 % and below 0,3 % weight by weight;
(c) By derogation of point (a): 27 November 2023 for uses in medical devices within the scope of Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
(a) 21 February 2015 (**)
(b) By way of derogation from point (a): 14 December 2024 for uses in:
food contact materials within the scope of Regulation (EC) No 1935/2004;
immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;
mixtures containing DEHP at or above 0,1 % and below 0,3 % weight by weight;
(c) By derogation of point (a): 27 May 2025 for uses in medical devices within the scope of Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
(a) 21 August 2013 (*)
(b) By way of derogation from point (a): 14 June 2023 for uses in:
immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;
mixtures containing BBP at or above 0,1 % and below 0,3 % weight by weight.
(a) 21 February 2015 (**)
(b) By way of derogation from point (a): 14 December 2024 for uses in:
immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;
mixtures containing BBP at or above 0,1 % and below 0,3 % weight by weight.
(a) 21 August 2013 (*)
(b) By way of derogation from point (a): 14 June 2023 for uses in:
immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;
mixtures containing DBP at or above 0,1 % and below 0,3 % weight by weight.
(a) 21 February 2015 (**)
(b) By way of derogation from point (a): 14 December 2024 for uses in:
immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC;
mixtures containing DBP at or above 0,1 % and below 0,3 % weight by weight.
(a) 21 August 2013 (*)
(b) By way of derogation from point (a): 14 June 2023 for uses in mixtures containing DIBP at or above 0,1 % and below 0,3 % weight by weight.
(a) 21 February 2015 (**)
(b) By way of derogation from point (a): 14 December 2024 for uses in mixtures containing DIBP at or above 0,1 % and below 0,3 % weight by weight.
Versions
Cited by
- Commission Regulation (EU) 2023/2482 of 13 November 2023 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices (Text with EEA relevance) Regulation · Grade B
Commission Regulation (EU) 2021/2045 amending Annex XIV to Regulation (EC) No 1907/2006 sets 27 May 2025 as sunset date and 27 November 2023 as latest application date for uses of the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices. In accordance with Article 56(1) of Regulation (EC) No 1907/2006, such uses of DEHP are not allowed after the sunset date unless an authorisation has been granted for a particular use, or unless an application for authorisation for a given use was submitted before the latest application date and a decision on the application has not yet been taken.
- Commission Regulation (EU) 2023/2482 of 13 November 2023 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices (Text with EEA relevance) Regulation · Grade B
The sunset date and the latest application date for DEHP in Regulation (EU) 2021/2045 were aligned with the transitional provisions laid down in Regulations (EU) 2017/745 and (EU) 2017/746 of the European Parliament and of the Council. Those transitional provisions provided that medical devices with a valid certificate issued under Council Directives 90/385/EEC and 93/42/EEC or Directive 98/79/EC of the European Parliament and the Council could be placed on the market until 26 May 2024 and continue to be made available on the market or put into service until 26 May 2025.