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Annex XIV - LIST OF SUBSTANCES SUBJECT TO AUTHORISATION

Annex XIV
LIST OF SUBSTANCES SUBJECT TO AUTHORISATION

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)

1.

5-tert-butyl-2,4,6-trinitro-m-xylene (Musk xylene) EC No: 201-329-4 CAS No: 81-15-2

vPvB

21 February 2013

21 August 2014

—

—

2.

4,4’-Diaminodiphenylmethane (MDA) EC No: 202-974-4 CAS No: 101-77-9

Carcinogenic (category 1B)

21 February 2013

21 August 2014

—

—

3.

Hexabromocyclododecane (HBCDD) EC No: 221-695-9, 247-148-4, CAS No: 3194-55-6 25637-99-4 alpha-hexabromocyclododecane CAS No: 134237-50-6, beta-hexabromocyclododecane CAS No: 134237-51-7 gamma-hexabromocyclododecane CAS No: 134237-52-8

PBT

21 February 2014

21 August 2015

—

—

4.

Bis(2-ethylhexyl) phthalate (DEHP) EC No: 204-211-0 CAS No: 117-81-7

Toxic for reproduction (category 1B)

21 August 2013

21 February 2015

Uses in the immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC.

5.

Benzyl butyl phthalate (BBP) EC No: 201-622-7 CAS No: 85-68-7

Toxic for reproduction (category 1B)

21 August 2013

21 February 2015

Uses in the immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC.

6.

Dibutyl phthalate (DBP) EC No: 201-557-4 CAS No: 84-74-2

Toxic for reproduction (category 1B)

21 August 2013

21 February 2015

Uses in the immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC.

(1) Date referred to in Article 58(1)(c)(ii) of Regulation (EC) No 1907/2006. (2) Date referred to in Article 58(1)(c)(i) of Regulation (EC) No 1907/2006.

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