PIC Factsheet

Chemicals Subject to PIC - Factsheet

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PIC - Prior Informed Consent Regulation

Substances subject to export controls or banned from export from the EU under the PIC Regulation

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4,4'-Diaminodiphenylmethane (MDA)
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CAS No: 101-77-9
EC No: 202-974-4
Current PIC Context
Annex Legal Act Category Subcategory Use Limitation From To
Annex I Part 2
Annex I Part 1
Annex I Part 1
643/2022 Industrial Chemicals
Industrial Chemicals
Industrial Chemicals

Industrial chemicals for consumer use
Industrial chemicals for professional use
Severely Restricted
Banned
Severely Restricted
01-07-2022
PIC Regulatory History
Annex Legal Act Category Subcategory Use Limitation From To
Annex I Part 2
Annex I Part 1
Annex I Part 1
643/2022 Industrial Chemicals
Industrial Chemicals
Industrial Chemicals

Industrial chemicals for consumer use
Industrial chemicals for professional use
Severely Restricted
Banned
Severely Restricted
01-07-2022
Legislation text

The substance 4,4'-Diaminodiphenylmethane (MDA) is listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (REACH) (OJ L 396, 30.12.2006, p. 1-849), since it has been identified as a substance of very high concern. Consequently, this substance is subject to authorisation. Since no authorisation was granted, this substance is severely restricted for industrial use.

In accordance with entry 28 of Annex XVII 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) (OJ L 396, 30.12.2006, p. 1-849), the following applies to substances which appear in Part 3 of Annex VI to Regulation (EC) No 1272/2008 classified as carcinogen category 1A or 1B or carcinogen category 1 or 2, including 4,4'-Diaminodiphenylmethane (MDA):

1. Shall not be placed on the market, or used,
— as substances,
— as constituents of other substances, or,
— in mixtures,
for supply to the general public when the individual concentration in the substance or mixture is equal to or greater than:
— either the relevant specific concentration limit specified in Part 3 of Annex VI to Regulation (EC) No 1272/2008, or,
— the relevant generic concentration limit specified in Part 3 of Annex I of Regulation (EC) No 1272/2008.

Without prejudice to the implementation of other Community provisions relating to the classification, packaging and labelling of substances and mixtures, suppliers shall ensure before the placing on the market that the packaging of such substances and mixtures is marked visibly, legibly and indelibly as follows: ‘Restricted to professional users’.

2. By way of derogation, paragraph 1 shall not apply to:

(a) medicinal or veterinary products as defined by Directive 2001/82/EC and Directive 2001/83/EC;
(b) cosmetic products as defined by Directive 76/768/ EEC;
(c) the following fuels and oil products:
— motor fuels which are covered by Directive 98/ 70/EC,
— mineral oil products intended for use as fuel in mobile or fixed combustion plants,
— fuels sold in closed systems (e.g. liquid gas bottles);
(d) artists’ paints covered by Regulation (EC) No 1272/2008;
(e) […];
(f) devices covered by Regulation (EU) 2017/745*.

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(*) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1–175).
Submitted Data for 4,4'-Diaminodiphenylmethane (MDA)