Eight Chemicals Added to the List of Substances Subject to Authorisation (Annex XIV of REACH)

Eight more substances of very high concern have been added to the REACH Authorisation list, following a Decision adopted by the European Commission on 14 February 2012 and published today in the Official Journal of the European Union.

These eight chemicals, which are all carcinogenic and/or toxic for reproduction, are:

diisobutyl phthalate (DIBP)
diarsenic trioxide
diarsenic pentaoxide
lead chromate
lead sulfochromate yellow (C.I. Pigment Yellow 34)
lead chromate molybdate sulphate red (C.I. Pigment Red 104)
tris (2-chloroethyl) phosphate (TCEP)
2,4-dinitrotoluene (2,4-DNT)

The first six substances have been listed for Authorisation in Annex XIV of REACH by Regulation (EU) No 143/2011, as follows:

5-tert-butyl-2,4,6-trinitro-m-xylene (Musk Xylene)
4,4’-Diaminodiphenylmethane (MDA)
Hexabromocyclododecane (HBCDD)
Bis (2-ethylhexyl) phthalate) (DEHP)
Benzyl butyl phthalate (BBP)
Dibutyl phthalate (DBP)

The newly added 8 substances along with the 6 substances which are already in the list make the number of the substances in the REACH Authorisation list total 14. (Refer to the list below)

The Challenge:
EU sets the latest application date for the Authorised use of each substance. The Sunset Date takes effect after a further 18 months, after which the marketing and use of each substance will be banned for all uses within the scope of REACH, unless Authorised or exempted. These dates and further details are shown in the table overleaf.

This ban will only cover these fourteen substances when they are:

Supplied on their own;
Supplied in a mixture;
Incorporated into an article within the European Union.

Imported articles containing any of these substances that were incorporated into the articles outside of the EU are not covered by the Authorisation process. However, the European Chemicals Agency (ECHA) is then obliged to consider whether these pose a risk to human health or the environment when contained within articles. If so, they will be considered under the Restriction process for addition to REACH Annex XVII. E.g. of these 14 substances, DEHP, BBP and DBP are already restricted under Annex XVII in toys and child care articles (incorporating the old Phthalates Directive 2005/84/EC).

Our Solution:
Intertek provides comprehensive logistical, operational, consulting, and engineering solutions for REACH (Registration, Evaluation and Authorization of Chemical Substances – Regulation (EC) No 1907/2006) compliance. Working with our clients, the European Chemicals Agency (ECHA), and the individual EU governments, Intertek provides a single-source solution for meeting the registration, testing, and documentation requirements of the REACH Regulation. Supported by our locations in over 100 countries worldwide, Intertek enables companies to facilitate their REACH compliance.

List of Substances Subject to Authorisation (REACH Annex XIV) (Up to now):

Substance	Intrinsic property(ies) referred to in Article 57	Transitional arrangements		Exempted (categories of) uses	Typical uses
Substance	Intrinsic property(ies) referred to in Article 57	Latest application date	Sunset date	Exempted (categories of) uses	Typical uses
5-tert-butyl-2,4,6- trinitro-m-xylene (Musk xylene) EC No: 201-329-4 CAS No: 81-15-2	Very persistent, very bioaccumulative (vPvB)	21 February 2013	21 August 2014	-	Cosmetics and soap perfumes
4,4’-Diaminodiphenylmethane (MDA) EC No: 202-974-4 CAS No: 101-77-9	Carcinogenic (category 1B)	21 February 2013	21 August 2014	-	Curing agent for epoxy resin in PCB, preparation of PU, azo dyes in garments
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	Persistent, bioaccumulative and toxic (PBT)	21 February 2014	21 August 2015	-	Flame retardant used in HIPS and textiles
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	Plasticizer for resin, PVC, blister
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	Plasticizer for resin, PVC, acrylics
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	Plasticizer, in adhesives and paper coatings; insect repellent for textiles
Diisobutyl phthalate (DIBP) EC No：201-553-2 CAS No：84-69-5	Toxic for reproduction (category 1B)	21 August 2013	21 February 2015		Plasticizer
Diarsenic trioxide EC No：215-481-4 CAS No：1327-53-3	Carcinogenic (category 1A)	21 November 2013	21 May 2015		Weed killers, timber preservatives, manufacture of special glass
Diarsenic pentaoxide EC No：215-116-9 CAS No：1303-28-2	Carcinogenic (category 1A)	21 November 2013	21 May 2015		Insecticides, weed killer, wood preservatives, coloured glass, dyeing and printing
Lead chromate EC No：231-846-0 CAS No：7758-97-6	Carcinogenic (category 1B) Toxic for reproduction (category 1A)	21 November 2013	21 May 2015		Used as colorant in painting, printing inks, rubber and plastic
Lead sulfochromate yellow (C.I. Pigment Yellow 34) EC No：215-693-7 CAS No：1344-37-2	Carcinogenic (category 1B) Toxic for reproduction (category 1A)	21 November 2013	21 May 2015		Used as colorant in painting, printing inks and plastic
Lead chromate molybdate sulphate red (C.I. Pigment Red 104) EC No：235-759-9 CAS No：12656-85-8	Carcinogenic (category 1B) Toxic for reproduction (category 1A)	21 November 2013	21 May 2015		Used as additives for painting and coatings, printing inks and in plastics
Tris (2-chloroethyl) phosphate (TCEP) EC No：204-118-5 CAS No：115-96-8	Toxic for reproduction (category 1B)	21 February 2013	21 August 2015		Flame retardant, plasticizer
2,4-dinitrotoluene (2,4-DNT) EC No：204-450-0 CAS No：121-14-2	Carcinogenic (category 1B)	21 February 2013	21 August 2015		Manufacture of explosives, polyurethane plastics, organic synthesis, dyes

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