CLP Regulation

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Regulation (EC) No 1272/2008
European Union regulation
Text with EEA relevance
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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 by European Parliament and Council
Made underArt. 95 (EC)
Journal reference L353, 31.12.2008, pp. 1–1355
History
Date made16 December 2008
Came into force20 January 2009
Preparative texts
Commission proposal COM (2007) 355 final, C191, 17.8.2008, p. 9
EESC opinion C204, 9.8.2008, pp. 47–56
EP opinion3 September 2008
Other legislation
Replaces Dir. 67/548/EEC
Dir. 1999/45/EC
Amends Reg. (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]

Contents

Content

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

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

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

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

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 ]

Related Research Articles

<span class="mw-page-title-main">Safety data sheet</span> Sheet listing work-related hazards

A safety data sheet (SDS), material safety data sheet (MSDS), or product safety data sheet (PSDS) is a document that lists information relating to occupational safety and health for the use of various substances and products. SDSs are a widely used system for cataloguing information on chemicals, chemical compounds, and chemical mixtures. SDS information may include instructions for the safe use and potential hazards associated with a particular material or product, along with spill-handling procedures. The older MSDS formats could vary from source to source within a country depending on national requirements; however, the newer SDS format is internationally standardized.

Risk and Safety Statements, also known as R/S statements, R/S numbers, R/S phrases, and R/S sentences, is a system of hazard codes and phrases for labeling dangerous chemicals and compounds. The R/S statement of a compound consists of a risk part (R) and a safety part (S), each followed by a combination of numbers. Each number corresponds to a phrase. The phrase corresponding to the letter/number combination has the same meaning in different languages—see 'languages' in the menu on the left.

<span class="mw-page-title-main">Directive 67/548/EEC</span>

The Dangerous Substances Directive was one of the main European Union laws concerning chemical safety, until its full replacement by the new regulation CLP Regulation (2008), starting in 2016. It was made under Article 100 of the Treaty of Rome. By agreement, it is also applicable in the EEA, and compliance with the directive will ensure compliance with the relevant Swiss laws. The Directive ceased to be in force on 31 May 2015 and was repealed by 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.

<span class="mw-page-title-main">European Community number</span> Identifier for substance regulated within EU

The European Community number is a unique seven-digit identifier that was assigned to substances for regulatory purposes within the European Union by the European Commission. The EC Inventory comprises three individual inventories, EINECS, ELINCS and the NLP list.

<span class="mw-page-title-main">Control of Substances Hazardous to Health Regulations 2002</span> United Kingdom legislation

The Control of Substances Hazardous to Health Regulations 2002 is a United Kingdom Statutory Instrument which states general requirements imposed on employers to protect employees and other persons from the hazards of substances used at work by risk assessment, control of exposure, health surveillance and incident planning. There are also duties on employees to take care of their own exposure to hazardous substances and prohibitions on the import of certain substances into the European Economic Area. The regulations reenacted, with amendments, the Control of Substances Hazardous to Work Regulations 1999 and implement several European Union directives.

The European Chemicals Bureau (ECB) was the focal point for the data and assessment procedure on dangerous chemicals within the European Union (EU). The ECB was located in Ispra, Italy, within the Joint Research Centre (JRC) of the European Commission. In 2008 the ECB completed its mandate. Some of its activities were taken over by the European Chemicals Agency (ECHA); others remained within the Joint Research Centre. The history of the ECB has been published as a JRC technical report.

<span class="mw-page-title-main">Cosmetics Directive</span>

Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products was the main European Union law on the safety of cosmetics. It was made under Art. 100 of the Treaty of Rome. By agreement, it was also applicable in the European Economic Area.

<span class="mw-page-title-main">Dangerous Preparations Directive</span>

The Dangerous Preparations Directive is a European Union directive in the field of occupational safety and health and consumer protection. It complements the Dangerous Substances Directive (67/548/EEC) and replaces a previous Dangerous Preparations Directive (88/379/EEC). The European Court of Justice had ruled in 1985 that Dangerous Substances Directive (67/548/EEC) applies only to pure substances, not preparations.

Hazard statements form part of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). They are intended to form a set of standardized phrases about the hazards of chemical substances and mixtures that can be translated into different languages. As such, they serve the same purpose as the well-known R-phrases, which they are intended to replace.

Precautionary statements form part of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). They are intended to form a set of standardized phrases giving advice about the correct handling of chemical substances and mixtures, which can be translated into different languages. As such, they serve the same purpose as the well-known S-phrases, which they are intended to replace.

Hazard pictograms form part of the international Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Two sets of pictograms are included within the GHS: one for the labelling of containers and for workplace hazard warnings, and a second for use during the transport of dangerous goods. Either one or the other is chosen, depending on the target audience, but the two are not used together. The two sets of pictograms use the same symbols for the same hazards, although certain symbols are not required for transport pictograms. Transport pictograms come in wider variety of colors and may contain additional information such as a subcategory number.

<span class="mw-page-title-main">Musk xylene</span> Chemical compound

Musk xylene is a synthetic musk fragrance which mimics natural musk. It has been used as a perfume fixative in a wide variety of consumer products, and is still used in some cosmetics and fragrances.

<span class="mw-page-title-main">Reproductive toxicity</span> A hazard associated with chemical substances

Reproductive toxicity refers to the potential risk from a given chemical, physical or biologic agent to adversely affect both male and female fertility as well as offspring development. Reproductive toxicants may adversely affect sexual function, ovarian failure, fertility as well as causing developmental toxicity in the offspring. Lowered effective fertility related to reproductive toxicity relates to both male and female effects alike and is reflected in decreased sperm counts, semen quality and ovarian failure. Infertility is medically defined as a failure of a couple to conceive over the course of one year of unprotected intercourse. As many as 20% of couples experience infertility. Among men, oligospermia is defined as a paucity of viable spermatozoa in the semen, whereas azoospermia refers to the complete of absence of viable spermatozoa in the semen.

<span class="mw-page-title-main">1,4-Dichlorobut-2-ene</span> Chemical compound

1,4-Dichlorobut-2-ene is a chlorinated butene. It is an intermediate in the industrial production of chloroprene, and the main impurity in technical grade chloroprene. The (E)-isomer is also one of the starting materials for Birman's total synthesis of the poriferic natural product sceptrin.

<span class="mw-page-title-main">Hexyllithium</span> Chemical compound

n-Hexyllithium, C6H13Li, sometimes abbreviated to HxLi or NHL, is an organolithium compound used in organic synthesis as a strong base or as a lithiation reagent. It is usually encountered as a colorless or pale yellow solution in hexanes. Such solutions are highly sensitive to air and can ignite when treated with water.

European hazard symbols for chemicals are pictograms defined by the European Union for labelling chemical packaging and containers. They are standardised currently by the CLP/GHS classification.

The Substitute It Now! List is a database developed by the International Chemical Secretariat (ChemSec) of chemicals the uses of which are likely to become legally restricted under EU REACH regulation. The list is being used by public interest groups as a campaign tool to advocate for increasing the pace of implementation of REACH and by commercial interests to identify substances for control in chemicals management programmes.

Technical Guidance WM2: Hazardous Waste: Interpretation of the definition and classification of hazardous waste is a guidance document developed and jointly published by the English Environment Agency, Natural Resources Wales, Scottish Environment Protection Agency and the Northern Ireland Environment Agency to provide guidance on the assessment and classification of hazardous waste based on the revised Waste Framework Directive definition of hazardous waste. Waste producers, consultants, contractors and waste management companies use the guidance to a) identify the correct waste code for their waste and b) determine whether the waste is hazardous or not based on its chemical composition.

<span class="mw-page-title-main">Unique formula identifier</span>

The unique formula identifier (UFI) is a code printed on products with hazardous mixtures in the European Economic Area (EEA), meant to help calls to poison control centers to determine the contents.

References

  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. 1849.
  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. 1 2 "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.
  8. Chemical Glossary : CLP Regulation, reagent.co.uk
  9. Labels – make sure you’re legal after 1 June 2017 , European Chemicals Agency
  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