2024-06-07 07:16:18
This article is reproduced from dialogue sous licensed under Creative Commons. liraOriginal article.
The Reach regulation (French for Registration, Evaluation, Authorization of Chemicals, or Registration, Evaluation and Authorization of Chemical Products), adopted by the EU in 2006, regulates the production and use of chemical substances in Europe, but has often been criticized for it. and complex.
so that its revision is judged necessary Some people, within the framework of the European Green Deal, ended up being Delay by the European Commission. Different NGOs have emphasized the need carry out such reforms. There european affairs committee The topic was relaunched in February 2024 and a resolution is currently under consideration.
Still, it’s a Ambitious and important European regulation Protect human health and the environment from the hazards and risks associated with chemical substances. Even if not perfect, it is progress compared to previous regulatory frameworks.
It was Reach that made the ban controversial Bisphenol A In some products, such as baby bottles. It represents a European success story, which is useful to look back on in the days leading up to the 2024 European elections.
Reach range, instructions for use
However, how Reach works is not difficult to understand, once we distinguish the different stages it involves.
The first step is Substance registration. Manufacturers are obliged to transmit (or even produce, if no pre-existing data exist) full information on the physicochemical, toxicological and ecotoxicological properties of the substances they manufacture or import. Unlike previous regulations and directives, Reach places the burden of proof on companies. Comply with regulations, companies must identify and adequately manage the risks associated with the substances they produce and sell in the EU. In particular, they must demonstrate how to use the substance safely and communicate risk management measures to users. The second step involves verifying that the documents transmitted by the manufacturer are compliant. Therefore, ECHA is responsible for verifying Is the registration document of the substance complete? or information required by regulations is missing. This process is called Compliance Analysis. Then, if specific issues are found, Can evaluate substances, this is to ensure that there are no risks to human health and the environment. For this purpose we use the data communicated by the manufacturer in the first phase. The procedure is carried out by member states, including ANSES in France, and can require further information from manufacturers in response to identified concerns about a substance. The choice of substances to evaluate is often based on each country’s national public health priorities.
That’s the big step. But to fully understand the issues with this process, there are some important subtleties:
Specifically, what happens when a member state decides to assess a substance? This is registered in ongoing community action plan (Community Rolling Action Plan, CoRAP), which means that member states have, will or are evaluating it. these are the plans Covers the next three years. What does the evaluation of chemical substances mean? This is an in-depth evaluation of the technical and scientific data provided by the manufacturer during registration. It must be able to identify additional information requested by the filer to remove any doubts about the hazards or risks associated with the substance.
Once additional information has been provided and reassessed, if management action is required, different procedures can be considered within the Reach framework:
Proposals to identify the substance as a Substance of Very High Concern (SVHC), proposals to restrict the use of the substance, proposals for classification and labeling (carcinogenic, mutagenic or reproductive toxic effects, respiratory sensitization, etc.), or even actions not covered by the Reach Regulation, Examples include proposals for occupational exposure limits at European level, national measures or even voluntary actions by companies.
Bisphenol A, an iconic case
A classic example of a successful Reach regulation is bisphenol A (4,4′-isopropylidenediphenol). In 2017, Germany ranked first commented Pull matter.
then:
Even though these different management measures attacked in court Manufacturers, including the appeals process, have Approved. As a report from the European Environment Agency (EEA) shows, they are already bearing fruit. BPA concentrations appear to be declining Unlike other bisphenols, this substance is found in the urine of Europeans.
The role of ANSES
ANSES, like other agencies in the European Economic Area, is involved in the implementation of Reach and in supporting the various procedures of the French authorities.
In particular, it produces partial files Used to identify substances of very high concern (High Concern Substances). These files allow their subsequent inclusion in Reach Annex XIVwhich lists substances requiring authorization.
These products can then no longer be used outside the express uses authorized by the European Commission. The authorization may be granted at the discretion of the Commission if it is demonstrated that the risks are controlled or the socio-economic benefits outweigh the risks in the absence of alternatives.
Substances to be included in Annex XIV must first be identified as SVHC substances. This procedure aims to ensure that SVHC substances are controlled and progressively replaced by substances that are safer for health and/or the environment.
ANSES also developed restricted files, which includes, inter alia, an analysis of the socio-economic impact of planning restrictions. Restrictions are tools that limit or even prohibit the manufacture, use and/or placing on the market of a substance, either as such or contained in a mixture, or even in a manner that poses a threat to humans or the environment. Substances in products with unacceptable risk.
Finally, ANSES produces harmonized classification documents—primarily for carcinogens, mutagens, reproductive toxicants, and respiratory sensitizers. They allow chemicals to be added to Annex VI Classification, labeling and packaging regulations (CLP), and member states Agree on a common classification It’s called “harmony.”
The manufacturer is then obliged to communicate the classification used on the product label. This makes it possible to inform users (especially workers) of their hazards and to take all appropriate measures to avoid long-term exposure and limit their health risks.
Useful but Improveable Provisions
Nonetheless, relevant regulations still need to be improved. Despite the efforts of the European authorities, not all manufacturers participate due to the cost of the registration procedure, in particular small companies. German Institute for Risk Assessment (BfR) noted in 2018 Chemical substances 31% Products produced or imported into the EU in quantities exceeding 1,000 tons per year do not comply with REACH regulations.
In response, ECHA improved its management chemical data. This does not satisfy manufacturers, who criticize it for proposing classifications or requiring new tests for substances There is not always a valid toxicological rationaleand these requests are intended to fill gaps in the registration documents provided by these manufacturers and limit the use of animal testing.
This is the main limitation of Reach: the regulation relies heavily on data transmitted by manufacturers to assess the hazards and risks inherent in chemicals. However, this data may be limited, outdated, or even non-existent in registration documents, forcing assessors to request additional information, which may impact the effectiveness and speed of risk assessment and decision-making.
result, The process of evaluating documents and substances and then reviewing authorization requests is lengthy, which may delay the launch of new, safer and more innovative substances, which is questionable from a health perspective. Likewise, many potentially hazardous substances are already on the market but have not been evaluated or regulated as rigorously as they should be.
Upcoming regulatory revisions will improve various procedures to make them more efficient, faster and more stringent for manufacturers who do not comply with regulatory requirements. In particular, it is expected Delete its Reach registration numberwhich will prevent them from continuing to sell chemicals for which the requested information has not been provided.
These suggestions are European Commission Sustainable Chemistry Strategy for Non-Toxic Environments This is European Green Deal. Unless this renegotiation is the subject of intense lobbying to clarify the world’s unique rules on safe use of chemicals.
Because despite the challenges, both for manufacturers who must comply with the regulation and for the authorities who must implement it, Reach remains vital and unique in protecting the health of the European region’s inhabitants and their environment.
This article was written by ANSES supervisory toxicologist Johanna Berneron
1722671660
#Reach #European #Chemical #Substances #Regulation #work #handle
