On 23 December 2021, the European Union has released the COMMISSION REGULATION (EU) 2021/2045 to amend the Entry 4-7 (DEHP, BBP, DBP and DIBP) to REACH Annex XIV.

The amendments are as follows:

Entry Nr

Substance

Intrinsic property(ies) referred to in Article 57

Transitional arrangements

Exempted (categories of) uses

Review periods

Latest application date

Sunset date

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)

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.

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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)

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.

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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)

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.

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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 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.

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

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Further Information

Official Journal of the European Union