CLP Regulation

Regulation (EC) No 1272/2008
European Union regulation
Text with EEA relevance
TitleRegulation 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
Made byEuropean Parliament and Council
Made underArt. 95 (EC)
Journal referenceL353, 31.12.2008, pp. 1–1355
History
Date made16 December 2008
Entry into force20 January 2009
Preparative texts
Commission proposalCOM (2007) 355 final, C191, 17.8.2008, p. 9
EESC opinionC204, 9.8.2008, pp. 47–56
EP opinion3 September 2008
Other legislation
ReplacesDir. 67/548/EEC
Dir. 1999/45/EC
AmendsReg. (EC) No 1907/2006
Current legislation

The CLP Regulation[1] (for "Classification, Labelling and Packaging"[2]) is a European Union regulation from 2008, which aligns the European Union system of classification, labelling and packaging of chemical substances and mixtures to the Globally Harmonised System (GHS). It is expected to facilitate global trade and the harmonised communication of hazard information of chemicals and to promote regulatory efficiency. It complements the 2006 Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation (EC No 1907/2006)[3] and replaces an older system contained in the Dangerous Substances Directive (67/548/EEC)[4] and the Dangerous Preparations Directive (1999/45/EC).[5]

Content

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The European Union's 2008 Classification, Labelling and Packaging Regulation incorporates the classification criteria and labelling rules agreed at the UN level, the so-called Globally Harmonised System of Classification and Labelling of Chemicals (GHS). It introduced new classification criteria, european hazard symbols (pictograms) and Risk and Safety Statements for labelling, while taking into account elements which were part of the prior EU legislation.

The regulation requires companies to appropriately classify, label and package their substances and mixtures before placing them on the market. It aims to protect workers, consumers and the environment by labelling that reflects a particular chemical's possible hazards. It also addresses the notification of classifications, the establishment of a list of harmonised classifications and the creation of a classification and labelling inventory, as required by REACH.

Harmonised classification and labelling

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Classification and labelling is harmonised to ensure an adequate risk management for hazards of highest concern (carcinogenicity, mutagenicity, reproductive toxicity (CMR) and respiratory sensitisers) and for other substances on a case-by-case basis. This is done through the so-called harmonised classification and labelling (CLH).[6] Substances having CLH are listed in Annex VI to the CLP Regulation. Manufacturers, importers and downstream users of such substances and of mixtures containing such substances have to apply the CLH.[6]

Unique formula identifier

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The unique formula identifier (UFI, 16-digit code) will appear on product labels as a new identification element from 2020. By 2025, the UFI will become mandatory on the label of all products classified for health or physical hazards. Importers and downstream users placing such products on the market must provide specific product information, including the UFI, to poison centres.[7]

Implementation

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The regulation came into force in January 2009.[8] Manufacturers and importers had already pre-registered more than 140,000 substances with the European Chemicals Agency under the REACH Regulation. They had until 1 December 2010 to propose "provisional classifications" for these substances, which have been used for the labelling of pure substances since that date. The deadline for classifying mixtures was 31 May 2015. The deadline for re-labelling and re-packaging of products already on the market was two years later: 1 June 2017.[9]

Further legislation 2008–2009

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In 2008, Directive 2008/112/EC[10] and regulation (EC) No 1336/2008[11] adapted classification-based provisions in other existing EU legislation (“downstream legislation”) to the new rules.[jargon] Pursuant to article 53 of the CLP Regulation, in 2009 a first adaptation to the technical and scientific progress (ATP) was made with Commission Regulation 790/2009.[12][jargon]

References

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  1. ^ Full title: 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.
  2. ^ New classification, labelling and packaging regulation, European Chemicals Agency, archived from the original on 9 March 2009, retrieved 8 March 2009
  3. ^ 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. OJEC L396, 30.12.2006, pp. 1–849.
  4. ^ Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. OJEC L196, 16.8.1967, pp. 1–98; OJEC English special edition, Series I, Chapter 1967, p. 0234.
  5. ^ Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations. Archived 2008-05-28 at the Wayback Machine OJEC L200, 20.7.1999, pp. 1–68.
  6. ^ a b "Harmonised classification and labelling (CLH)". echa.europa.eu. Archived from the original on 2012-06-23. Retrieved 2021-12-14.
  7. ^ "The UFI and what it means for your product labels" (PDF). ECHA. Archived from the original (PDF) on 2019-02-18. Retrieved 2019-02-18.
  8. ^ Chemical Glossary : CLP Regulation, reagent.co.uk
  9. ^ European Chemicals Agency (ECHA). "Labels – make sure you're legal after 1 June 2017". newsletter.echa.europa.eu. Archived from the original on 10 November 2017. Retrieved 8 June 2024.
  10. ^ Directive 2008/112/EC of the European Parliament and of the Council of 16 December 2008 amending Council Directives 76/768/EEC, 88/378/EEC, 1999/13/EC and Directives 2000/53/EC, 2002/96/EC and 2004/42/EC of the European Parliament and of the Council in order to adapt them to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures
  11. ^ Regulation (EC) No 1336/2008 of the European Parliament and of the Council of 16 December 2008 amending Regulation (EC) No 648/2004 in order to adapt it to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures
  12. ^ Commission Regulation (EC) No 790/2009 of 10 August 2009 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures
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