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Päivi Jokiniemi and Paul Trouth
Article related to: CLP
How ECHA is assessing glyphosate
The criteria for classifying and labelling hazardous chemicals have been developed to protect human health and the environment. A topical example where the need for harmonised classification of a substance is being examined is glyphosate. ECHA’s Committee for Risk Assessment (RAC) is currently evaluating the proposal by Germany to revise its existing classification.
Classification and labelling is one of the ways of ensuring that the risks of hazardous chemicals are managed within the European Union. Substances that can burn the skin, are poisonous when swallowed, or are dangerous to inhale, for example, need to be classified and appropriately labelled. When the classification of a substance is harmonised, any product containing the substance must be appropriately labelled and packaged throughout the EU; this includes, where relevant, making sure that children cannot easily open the container or packaging.
EU Member States, manufacturers, importers and downstream users of chemicals may propose the harmonisation of the classification and labelling for a substance. If a harmonised classification already exists, a Member State can also propose to revise it.
Active substances in plant protection products generally have a harmonised classification. This is already the case with glyphosate, which is used as a weedkiller.
Proposal to revise the existing harmonised classification for glyphosate
Glyphosate already has harmonised classifications because of its irreversible effects on the eye (Eye Dam. 1, H318) and toxicity to aquatic life with long-lasting effects (Aquatic Chronic 2, H411). The German Federal Institute for Occupational Safety and Health (BAuA) has reviewed these existing harmonised classifications and proposed to add a classification for specific organ toxicity after repeated exposure (known as STOT RE 2, H373).
ECHA’s Committee for Risk Assessment (RAC) will evaluate this proposal as well as the other potential health hazards of glyphosate such as carcinogenicity, germ cell mutagenicity and reproductive toxicity, and possible environmental hazards, which have been addressed in the dossier but for which Germany has not proposed a classification.
The approval to use glyphosate as an active substance in plant protection products expired at the end of June 2016. The European Commission decided to extend the approval for 18 months, by which time – under normal circumstances – RAC will have adopted its opinion on glyphosate’s harmonised classification.
Public consultation on the proposal
After receiving the proposal for harmonised classification, ECHA checked that it fulfilled all legal requirements. The next step was to launch a 45-day public consultation that welcomed comments on the classification proposal, including the endpoints for which no classification was proposed. The consultation ended on 18 July and all the comments received have been sent to the German authority for them to consider and respond to – they are also available on ECHA’s website (after any confidential content has been removed).
The role of the Committee for Risk Assessment
RAC’s task is to prepare an opinion on the need for additional harmonised classifications of glyphosate. The committee considers the available data on the substance, including any scientifically relevant comments submitted during the public consultation. It then examines the available evidence and may consider whether another category other than that proposed would be more appropriate for the classification of the substance.
The classification is based solely on the hazardous properties of the substance. It does not take into account risk or exposure because the assessment does not evaluate the quantities used, nor the way in which it is used. Such aspects are considered later on, as part of further risk management measures when assessing if a certain use can be authorised. For example, the use of glyphosate as a pesticide is covered by the Plant Protection Products Regulation, which is managed by the European Food Safety Authority (EFSA).
Harmonised classification is important for the safe use of glyphosate
RAC's final opinion will be published on ECHA's website together with the background documents and responses to the comments received. In the course of next year, ECHA will forward RAC’s opinion, together with all the comments, to the European Commission. If the Commission finds that the proposed harmonised classification and labelling is appropriate, it will submit a draft decision concerning the inclusion of glyphosate on Annex VI to the CLP Regulation.
This means that all manufacturers, importers and users of the substance in the EU must classify it accordingly, enabling users to be better informed about it, its potential effects and how to use it safely.
What is glyphosate?
N-(Phosphonomethyl)glycine (EC 213-997-4, CAS 1071-83-6), or glyphosate (ISO), is one of the world’s most widely used active substances to prevent unwanted plant growth. These substances are referred to as herbicides or, more commonly, as “weedkillers”.
It is used in agriculture and horticulture to kill weeds before sowing. Some genetically modified plants have been developed to be resistant to glyphosate and in those cases, glyphosate is used to kill weeds once the crop has been sown. This practice however is not permitted in the European Union.
Source: BfR FAQ on the assessment of the health risk of glyphosate
Text by Nedyu Yasenov
Top image: Fotolia
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Biocidal Products Committee:
26 February-1 March
Committee for Risk Assessment:
Committee for Socio-Economic
18-22 March (tentative)
Management Board meeting:
Member State Committee:
13-17 May (tentative)