Glifosatas – tai viena plačiausiai pesticiduose naudojamų veikliųjų medžiagų, neleidžiančių nepageidaujamiems augalams augti greta pasodintų kultūrų arba sunaikinančių tokius augalus arba jų dalis. Šios cheminės medžiagos dažnai vadinamos herbicidais arba piktžoles naikinančiomis medžiagomis.
Glifosatas naudojamas žemės ūkyje ir sodininkystėje siekiant prieš sėją išnaikinti piktžoles. Tais atvejais, kai auginami glifosatui atsparūs genetiškai modifikuoti augalai, cheminė medžiaga taip pat naudojama po sėjos naikinant tarp kultūrų augančias piktžoles. Tačiau tokia praktika Europos Sąjungoje netaikoma.
ECHA prižiūri, kaip įgyvendinamas su cheminių medžiagų ir mišinių klasifikavimu ir ženklinimu susijęs teisės aktas. Šiuo teisės aktu reglamentuojama cheminių medžiagų vertinimo ir ženklinimo tvarka, atsižvelgiant į pavojingas savybes, kurių gali turėti tokios medžiagos (pvz., nuodai, degios cheminės medžiagos, ėsdinančios cheminės medžiagos ir pan.).
Dėl tam tikrų cheminių medžiagų, pvz., pesticidų, klasifikavimo sprendimas gali būti priimamas ES lygmeniu, tuomet jis galioja visoje Europoje. Praktiškai tai reiškia, kad bus reikalaujama naudoti atitinkamą ženklinimą, siekiant įspėti vartotojus apie kiekvieną produktą, kuriame yra cheminė medžiaga.
In 2019, the Glyphosate Renewal Group (GRG) formally applied to renew the approval of glyphosate for use after the current approval expires at the end of 2022.
Four EU Member States – France, Hungary, the Netherlands and Sweden – form the Assessment Group on Glyphosate (AGG). They assess the application and submit their reports to ECHA and European Food Safety Authority EFSA.
In parallel with EFSA's assessment, ECHA's Committee for Risk Assessment, RAC, will review the classification of glyphosate. RAC’s review will focus solely on the hazardous properties of the substance and will not take into account the likelihood of exposure to glyphosate.
RAC's assessment starts in 2021. A consultation on the classification proposal will be launched in September 2021. RAC's final opinion is expected in 2022 and it will feed into EFSA's risk assessment.
Based on EFSA's risk assessment, the European Commission will decide on the renewal of the approval of glyphosate.
The German Federal Institute for Occupational Safety and Health (BAuA) proposed that glyphosate should have an additional harmonised classification for specific target organ toxicity after repeated exposure (in addition to existing harmonised classifications). As set out in the CLP legislation, ECHA invited parties concerned to comment on this proposal in a public consultation, which closed on 18 July 2016.
The comments ECHA received were responded to by the German authority. Subsequently, ECHA's Committee for Risk Assessment (RAC) discussed the proposal for harmonised classification during two consecutive meetings – in December 2016 and March 2017 and prepared its independent scientific opinion.
RAC is a scientific committee, made up of experts nominated by the Member States of the European Union and appointed by ECHA. They considered the relevant data – including that provided by third parties. RAC also took into account the key information that was previously analysed by other bodies and considered the differing views on how some of those studies had been evaluated.
On 15 March 2017, RAC agreed to maintain the harmonised classification of glyphosate as a substance causing serious eye damage and being toxic to aquatic life with long-lasting effects. On 15 June, RAC submitted their independent scientific opinion to the European Commission on whether the intrinsic properties of glyphosate meet the legal criteria for classification set out in the Classification, Labelling and Packaging (CLP) Regulation. The adopted opinion as well as further information on the harmonised classification process is provided at the links below.
RAC and ECHA's assessment is solely based on the hazardous properties of the substance – is the substance capable of causing harmful effects? It does not take account of the risk or the extent to which people and the environment are exposed to the substance. This, of course, depends on how the substance is used and how much of it is used. Those detailed risks are therefore considered on a case-by-case basis under the relevant legislation. For glyphosate, it is the legislation on pesticides. That legislation – known as the Plant Protection Products Regulation – is managed by the European Commission and the European Food Safety Authority (EFSA). Further information on risk and exposure-related issues is provided at the links below.
Decision by EU Member States
Following adoption, RAC’s opinion was sent to the European Commission, and the Commission together with the Member States decided to renew the approval of glyphosate’s use as an active substance in plant protection products for five years (until 15 December 2022).
The decision was taken by EU Member State experts on 27 November 2017 and adopted by the Commission on 12 December 2017.
When conducting their assessments, regulatory agencies like ECHA rely on a combination of data from both published and unpublished toxicological studies.
Under EU law, there is a requirement on industry to ensure the safe use of chemical substances that they place on the market. Industry, therefore, has to conduct (eco)toxicology studies to identify the hazardous properties of these substances. These studies are paid for by industry.
Specialised laboratories that usually conduct these studies for the industry have to follow strict guidelines, which are laid down in EU legislation and related guidance documents. The studies must be performed in accordance with agreed methodology and must meet quality requirements (OECD or equivalent technical guidelines and good laboratory practice). This is the same process used, for example, for medicines.
The complete reports from these studies have been made available to the relevant regulatory authorities, including ECHA's Committee for Risk Assessment, for their verification of the information.
RAC's opinion on the classification of glyphosate and the responses to comments received are available on ECHA's website. The CLH report (including summaries of the studies) submitted by the German competent authority as well as the comments received during the public consultation are also available.
There have been several reports on glyphosate. Depending on the approach taken and the way in which the data have been considered, different conclusions have been reached. This is not unusual – interpreting and weighing scientific data requires judgement. However, the data available to the authors of these recent reports has also been considered by ECHA's Committee for Risk Assessment of independent experts from the EU Member States.
ECHA adopted an independent scientific opinion on the need for a harmonised classification for glyphosate, based on the hazard criteria set out in the Classification, Labelling and Packaging Regulation. As mentioned earlier, ECHA assessed the intrinsic hazardousness of glyphosate and not the risks associated with its individual uses. Those risks, for example, of using products containing glyphosate, are assessed under the Plant Protection Products Regulation.
Assessment Group on Glyphosate, AGG
ECHA's process in 2017