EU CLP Compliance Services
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Highlights on EU CLP
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EU CLP : Regulation (CE) 1272/2008 & Subsequent amendments [V_01.05.2020]
Brief Summary
The CLP Regulation (CE) 1272/2008 aligns previous EU legislation with the GHS (Globally Harmonised System of Classification and Labelling of Chemicals), a United Nations system to identify hazardous chemicals and to inform users about these hazards.
It also has links to Regulation (EC) No 1907/2006, the REACH Legislation.
The CLP Regulation entered into force on 20 January 2009 and progressively replaced the classification and labelling of Dangerous Substances (67/548/EEC) and Dangerous Preparations (1999/45/EC) Directives.
Both directives were repealed on 1 June 2015.
Under regulation (EC) No 1272/2008 (CLP), companies supplying chemicals as substances and/or preparations on the EU market, must classify, label and package these products in accordance with the regulation.
The principal categories of obligations are:
- Hazard classification of substances and mixtures [Title II]
- Hazards communication in the form of Labelling [Title III]
- Adequate packaging [Title IV]
- Notification of substances to the Classification and Labelling Inventory [Title VI]
• Substances subject to registration under regulation (EC) No 1907/2006 (REACH);
• Hazardous substances on their own or in mixtures otherwise not subject to REACH.
Classification of substances and mixtures according to CLP is mandatory since 1 June 2015.
The classification step is necessary to confirm whether a notification to the classification and labelling inventory is required in accordance with CLP Articles 39 and 40.
Since 1 December 2010, companies have a 30 days delay after placing a new substance on the market to submit a notification for this substance.
Terminology under EU CLP
Hazard class :
Means the nature of the physical, health or environmental hazard.
Hazard category :
Means the division of criteria within each hazard class, specifying hazard severity.
Hazard pictogram :
Means a graphical composition that includes a symbol plus other graphic elements, such as a border, background pattern or colour that is intended to convey specific information on the hazard concerned.
Hazard statement :
Means a phrase assigned to a hazard class and category that describes the nature of the hazards of a hazardous substance or mixture, including, where appropriate, the degree of hazard.
Signal word :
Means a word that indicates the relative level of severity of hazards to alert the reader to a potential hazard; the following two levels are distinguished:
(a) Danger means a signal word indicating the more severe hazard categories;
(b) Warning means a signal word indicating the less severe hazard categories.
Hazard statement :
Means a phrase assigned to a hazard class and category that describes the nature of the hazards of a hazardous substance or mixture, including, where appropriate, the degree of hazard.
Registrant :
Means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance under Regulation (EC) No 1907/2006.
The Agency :
Means the European Chemicals Agency established by Regulation (EC) No 1907/2006.
Competent authority :
Means the authority or authorities or bodies established by the Member States to carry out the obligations arising from this Regulation.
Package :
Means the complete product of the packing operation, consisting of the packaging and its contents.
Packaging :
Means one or more receptacles and any other components or materials necessary for the receptacles to perform their containment and other safety functions.
Substance :
Means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
Mixture :
Means a mixture or solution composed of two or more substances.
Article :
Means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.
Use :
Means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation.
Alloy :
Means a metallic material, homogeneous on a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means; alloys are considered to be mixtures for the purposes of this Regulation.
UN RTDG :
Means the United Nations Recommendations on the Transport of Dangerous Goods.
More definitions ...
Link: EU CLP definitions.
Our Regulatory Services on EU CLP
CLP Administrative and Helpdesk Services
- ¤ Setup and account management services
- • Account setup services
- • Management of all submitted notification dossiers in REACH-IT
- • Retrieval and transmission of submission information (ECHA submission reports, IUCLID 6 substance datasets)
- ¤ Regulatory services
- • Communications with ECHA and national authorities, driving of the compliance procedures
- • Transmission of the compliance documents to EU clients, EU authorities, and to Customs when required for goods entering the EC customs territory
- • Protection of Confidential Business Information
- • Archival and quick retrieval of the substance information required under CLP, for a period of at least 10 years after the last placing on the market. [Article 49]
- ¤ Additional administrative services
- • Full CLP HELPDESK support (Answering all client's inquiries on CLP)
- • Consolidated CLP regulation monitoring (Alerts)
Substance Classification Services
- ¤ Identification of harmonised classifications
- • If an harmonised classification for a substance is present in Annex VI of the CLP Regulation, this classification must be applied
- ¤ Identification of adequate and reliable data, from all possible venues
- • In-house data
- • Literature
- • Occupational hazard/accident databases
- • SIEF (data generated for REACH)
- • Information generated under other international chemical programmes
- • If sufficient adequate and reliable data cannot be sourced, substance testing may be required, see additionnal services section
- ¤ Evaluation of adequate and reliable data
- • For hazards not covered by a harmonised classification the classification must be performed by evaluating adequate and reliable data against the specific provisions of Annex I of CLP
- ¤ Translation of DSD classification into a CLP classification
- • For some hazards it may be possible to translate an existing classification - under Directive 67/548/EEC (DSD) in to a CLP classification using the translation table provided in Annex VII to CLP (only applicable to certain hazards)
- ¤ Assignment of M-Factors and Concentration limits
- • Where applicable, specific concentration limits and M-factors may be set by manufacturers, importers or downstreamusers
Substance Notification Services
- ¤ Collection of notification dossier elements
- • Identity of the notifier(s) responsible for placing the substance or substances on the market as specified in section 1 of Annex VI to Regulation (EC) No 1907/2006
- • Identity of the substance or substances as specified in section 2.1 to 2.3.4 to Annex VI to Regulation (EC) No1907/2006
- • Substance composition
- • Classification of the substance or substances in accordance with Article 13 to CLP
- • Specific concentration limits or M-factors, where applicable, in accordance with Article 10 to CLP together with ajustification using the relevant parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006
- • Label elements specified in points (d), (e) and (f) of Article 17(1) to CLP for the substance or substances together with any supplemental hazard statements for the substance, determined in accordance with Article 25(1)
- ¤ Dossier generation and submission
- • Dossiers are prepared using one of the following tools: IUCLID 6, Bulk XML or online via REACH-IT
- • All dossiers are submitted to ECHA electronically via REACH-IT
- ¤ Dossiers follow-up
- • Communication with ECHA until acceptance/validation of the notification dossier by the European Chemicals Agency
Additional CLP services
- ¤ Group notifications
- ¤ Classification of mixtures
- ¤ Substance & mixture labelling
- ¤ Substance & mixture testing
- ¤ Submission of request for use of an alternative chemical name
- ¤ Submission of proposal for harmonised classification and labelling of a substance
When time is of the essence...
- Within the shortest possible delays
- With more than 10 years of experience in the régulatory industry, our services are provided speedy and effectively in accordance with the target legislations and rules of procédures; as well as the rules within that govern the handling of business confidential informations.