How is GHS implemented in Europe?
In Europe, the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) is implemented by the Regulation (EC) Nº 1272/2008 on the Classification, Labelling and Packaging of substances and mixtures (commonly known as CLP Regulation).
CLP Regulation originally implemented Revision 2 of GHS and it has been constantly updated based on GHS revisions, which are published every two years. Thus, CLP Regulation incorporates GHS revisions through the Adaptations to Technical Progress (ATP). Currently, CLP Regulation adapts GHS Revision 9 to the European Union.
What is the CLP Regulation?
- •CLP Regulation is the adaptation of GHS to Europe and is to be implemented in all Member States of the European Union, and it shall be applied without exceptions nor modifications.
- •The principal aims of CLP Regulation are:
- •to ensure a high level of health and environmental protection;
- •to define the criteria for classification, labeling and packaging of chemical substances and mixtures; and
- •to facilitate the unrestricted movement of chemical substances, mixtures, and products.
- •CLP Regulation was initially published on December 16th, 2008, amending and repealing previous existing Dangerous Substances Directive 67/548/EEC and Dangerous Preparations Directive 1999/45/EC, as well as Regulation (EC) No 1907/2006.
- •CLP Regulation was implemented in a two-phase process. After a transition period, it became mandatory first for chemical substances (December 1st, 2010); and then for mixtures (June 1st, 2015).
- •The official organism responsible for CLP Regulation is the European Chemicals Agency (ECHA).
- •CLP Regulation is applicable to all chemical areas and includes all industrial sectors. There are, however, some exceptions of chemical products that fall out the scope of CLP Regulation:
- •medicinal products as defined in Directive 2001/83/EC;
- •veterinary medicinal products as defined in Directive 2001/82/EC;
- •cosmetic products as defined in Directive 76/768/EEC;
- •medical devices as defined in Directives 90/385/EEC, 93/42/EEC and 98/79/EC, which are invasive or used in direct physical contact with the human body;
- •food or feeding stuffs as defined in Regulation (EC) No 178/2002 including when they are used as food additives, as flavoring agents and in animal nutrition.
What are the most relevant points of CLP Regulation?
- •CLP Regulation determines whether a substance or mixture should be classified as hazardous, which is the starting point for communicating the hazard through safety data sheets (SDS) and labelling.
- •Whereas CLP Regulation establishes the guidelines for classification, labelling and packaging of hazardous chemicals, SDS format and content is regulated by Regulation (EU) Nº 2020/878 (which updated Annex II of REACH Regulation).
- •CLP Regulation is up to date with GHS latest revisions; ergo no classification hazards are excluded concerning CLP Regulation.
- •CLP Regulation covers all 17 physical hazards, 11 health hazards and 4 environmental hazards.
- •Hazards to the ozone layer is a different category.
- •This means that endocrine disruptors as well as Persistent, Bioaccumulative and Toxic (PBT) and very Persistent and very Bioaccumulative substances (vPvB) must be reported in the SDS and used for final product classification.
- •CLP Regulation establishes a harmonized classification of substances for the entire European Union, included in Annex VI of CLP Regulation,and should be applied by all manufacturers, importers or downstream users.
- •It requires manufacturers, importers or downstream users of substances or mixtures to classify, label and package their hazardous chemicals appropriately before placing them on the market.
- •SDS shall be prepared in the official language of the country they are intended for.
- •SDS must follow the standard 16-section format from GHS.
- •CLP Regulation also sets the criteria for Poison Centre Notification (PCN).
- •Same as the SDS, labels must be written in the official language of the destination country.
- •Minimum Labeling of hazardous products require clearly label containers with product identifiers, pictograms, signal words, hazards statements, precautionary statements, additional information (such as EUH sentences) and supplier information.
- •Moreover, depending on the type of hazardous product, other information could be mandatory to be reported in the labelling. Some examples are – and not limited to:
- •Organic Volatile Compounds (COV) according to Directive 2004/42/EC and Directive 2010/75/EU;
- •Detergent specific data according to Regulation (EC) Nº 684/2004;
- •Allergenic fragrances according to Regulation (EU) Nº 2023/1545;
- •Biocide commercialization and use according to Regulation (EU) Nº 528/2012.
What other specific chemical requirements apply to Member States?
The European Union is composed of 27 Member States. Although CLP Regulation is officially implemented in all of them and unifies chemical regulation, there are some other national legislations that add specific requirements to it and are characteristic from each Member State.
Such peculiarities have to be reported in the FDS and/or labelling depending on the country it is destined to.
- •Germany
- •WGK (Wassergefährdungsklasse): The German Federal Water Act requires that facilities handling substances hazardous to water shall be classified based on their potential danger into the following categories: WGK 1 (slightly hazardous to water), WGK 2 (clearly hazardous to water) or WGK 3 (very hazardous to water).
- •LGK (Lagerung von Gefahrstoffen in ortsbeweglichen Behältern): details the requirements of the Hazardous Substances Ordinance for the storage of hazardous substances with the aim of helping warehouse operators and planners to store them safely. Each LGK class defines specific requirements for the storage of certain substances, such as flammable liquids, toxic or corrosive substances.
- •France:
- •ICPE (Installations Classées pour la Protection de l'Environnement): French legislation on Classified Installations for the Protection of the Environment defines classified installations as "any industrial or agricultural site likely to generate risks or cause pollution or other damage, especially to the safety and health of residents." An installation is subject to ICPE legislation according to two criteria: its activity and its threshold. As soon as the regulatory thresholds for a certain activity are reached, the installation is classified. Thus, to lessen the risks of ICPE installations, French legislation describes a regulatory framework for the procedures to follow and how ICPE classified sites should be managed.
- •Spain:
- •APQ (Almacenamiento de Productos Químicos): it is a regulation that refers to storing, loading, unloading, or transporting of hazardous chemical products to ensure the safety of facilities and workers. There is a total of 11 (from APQ 0 to APQ 10) categories that are assigned based on hazards categories.
- •Denmark:
- •MAL-CODE: Danish regulation states that companies engaged in manufacturing, importing, or distributing chemicals must describe the hazardousness of a product. The MAL-CODE consists of two parts: the first one indicates the safety precautions to minimize inhalation of volatile vapors from the product. The higher the number, the more volatile the substances in the product. The second one indicates the safety measures to minimize health risks if there is an exposure of the product to the skin, eyes, respiratory system, or if ingested. The higher the number, the more harmful the product.
- •The Netherlands:
- •ABM (Algemene Beoordelings Methodiek): aims to ensure the proper implementation of water quality policy. According to ABM, it is necessary to know the aquatic hazard of a chemical product to be discharged through wastewater. The more hazardous the product is, the greater the effort required to decontaminate the discharge. According to ABM, the product will be classified into one of the following four categories: Z (substances on the list of Substances of Very High Concern (SVHC)); A (non-easily biodegradable aquatic harmful substances); B (easily biodegradable aquatic harmful substances; or C (substances naturally found in local surface water).
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