Implications of the new EU legislation on chemicals for Poisons Centres

Figures & data

Table 1. New legislation on chemicals in the European Union.

Old Directives	New Regulations	Relevance for Poisons Centres
Dangerous Substances Directive 67/548/EEC	Regulation on classification, labelling and packaging of substances and mixtures (CLP) Regulation (EC) No 1272/2008^Citation1	New hazard classification of substances.New hazard classification of mixtures.
Dangerous Preparations Directive 1999/45/EC		Article 45	Harmonisation of product notification (requirements and data exchange format).
Safety Data Sheet Directive 91/155/EEC >60 Substances Directives	Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation (EC) No 1907/2006^Citation2	Annex II	Improvement of toxicological information in Safety Data Sheets.
Cosmetics Products Directive 76/768/EEC	Cosmetic Products Regulation (EC) No 1223/2009^Citation3	Article 13	Notification of cosmetic products to a central EC database (Cosmetic Products Notification Portal). This information will be available for Poisons Centres and governmental authorities.
Plant Protection Products Directive 91/414/EEC	Plant Protection Products Regulation (EC) No 1107/2009^Citation4		The Plant Protection Products Regulation does not contain an article on product notification. Article 45 of the CLP Regulation applies also for this product group.
Biocidal Products Directive 98/8/EEC	Biocidal Products Regulation (EC) No XXXX/2011^Citation5 (forthcoming in 2011)	Article 63	For the notification of biocidal product information article 63 refers to article 45 of the CLP Regulation.

Table 2. EAPCCT guidelines 2010 on the required product composition.⁹ An exact concentration is required for substances with a certain hazard classification according to the CLP Regulation. For all other substances (classified differently or not classified) defined concentration ranges can be used.

CLP Regulation (EC) No 1272/2008		EAPCCT guidelines 2010
Hazard class	Categories	Exact concentration	Defined concentration ranges
Acute toxicity Oral	1, 2, 3, 4	1, 2, 3	4
Acute toxicity Dermal	1, 2, 3, 4	1, 2, 3	4
Acute toxicity Inhalation	1, 2, 3, 4	1, 2, 3	4
STOT - single exposure	1, 2, 3	1, 2	3
STOT - repeated exposure	1, 2	1, 2
Aspiration hazard	1		1
Skin corrosion/ irritation	1ABC, 2	1ABC	2
Eye damage/ irritation	1, 2	1	2
Respiratory sensitisation	1		1
Skin sensitisation	1		1
Carcinogenicity	1AB, 2		1AB, 2
Germ cell mutagenicity	1AB, 2		1AB, 2
Reproductive toxicity	1AB, 2		1AB, 2
Effects on or via lactation

STOT: Specific Target Organ Toxicity.

Defined concentration ranges:

>0– ≤0,1%, >0,1– ≤1%, >1– ≤3%, >3– ≤10%, >10– ≤20%, >20– ≤30%, >30– ≤50%, >50– ≤75%, >75%.

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. http://eur-lex.europa.eu/Notice.do?val = 486098:cs&lang = en&list = 490877:cs,486098:cs,&pos = 2&page = 1&nbl = 2&pgs = 10&hwords. Accessed 13 July 2011.

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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. http://eur-lex.europa.eu/Notice.do?val = 444402:cs&lang = en&list = 516890:cs,516899:cs,515837:cs,488164:cs,471644:cs,449533:cs,444402:cs,&pos = 7&page = 1&nbl = 7&pgs = 10&hwords. Accessed 13 July 2011.

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Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. http://eur-lex.europa.eu/Notice.do?val = 505838:cs&lang = en&list = 525784:cs,505838:cs,&pos = 2&page = 1&nbl = 2&pgs = 10&hwords. Accessed 13 July 2011.

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Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. http://eur-lex.europa.eu/Notice.do?val = 504604:cs&lang = en&list = 504604:cs,&pos = 1&page = 1&nbl = 1&pgs = 10&hwords. Accessed 13 July 2011.

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Proposal for a Regulation of the European Parliament and of the Council concerning the placing on the market and use of biocidal products. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri = CELEX:DKEY = 496597:EN:NOT. Accessed 13 July 2011.

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Harmonisation of Information for Poison Centres – Stakeholder workshop report. European Commission – Enterprise and Industry. 2011. ISBN 978-92-79-18406-2. http://ec.europa.eu/enterprise/sectors/chemicals/classification/clp_workshop_en.htm. Accessed 13 July 2011.

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