New concentration limit for endocrine disruptors
On 22 and 23 June, at a meeting of the EU biocides competent authorities, a new concentration limit was decided.
A substance is said to be of concern if its concentration exceeds the limit set at 0.1% for a non-active substance identified as an endocrine disruptor and contained in a biocidal product.
This limit is also valid when several substances identified as endocrine disruptors add up. If the individual concentrations are lower, the limit still applies, if the total sum of the concentrations exceeds the limit.
In 2021, the Biocidal Products Committee (BPC) shared its opinion on the approval of ozone. According to the committee, an investigation should be conducted by the Commission, regarding the use of the gas by the general public. In this regard, during the meeting, clarifications were made regarding the approval of in situ generated biocidal substances for use by the general public. In particular, the approval of ozone generated from oxygen for the following uses:
- disinfectants and algicides not intended for direct application to humans or animals (product type 2)
- food and feed sector (product type 4)
- drinking water (Product-type 5); and
- preservatives for cooling and liquid treatment systems (product type 11).
Finally, the meeting concluded that an in situ generated biocidal product should not be allowed for public use if it meets any of the hazard criteria of the PBR (e.g. carcinogenic, mutagenic, etc.).
Regulations in force and dates to remember
The REACH and Biocides regulations are in agreement on the authorization limit agreed by the EU competent authorities for biocides.
In accordance with the CLP Regulation and upon application for Union or national authorisation under the PBR, precautionary statements triggered by the hazard classification of a product will need to be listed in the Summary of Product Characteristics (SPC).
A next meeting is planned, by the end of the year, to bring additional elements on this subject. The provisional date is set for October 04 to 06, 2022.
Definition of endocrine disruptors
The European Commission defines endocrine disruptors as chemicals that can have adverse effects on the body's hormonal system.
The main products that may contain endocrine disruptors are:
- pesticides and fertilizers ;
- medicines;
- cosmetics;
- metals;
- various chemical substances (e.g. bisphenol).
The concept of endocrine disruptors is of concern to the public because of their negative effects on health and the environment.
At the European Union level, specific legislation is in place to progressively eliminate endocrine disruptors in water, industrial chemicals, plant protection products and biocides.
In France, the ANSES (Agency for Food, Environmental and Occupational Health & Safety) is conducting work on the evaluation of biocidal and phytopharmaceutical substances.
According to them, 300 plant protection substances will be evaluated for their endocrine disrupting properties by the Member States. Concerning biocidal substances, 100 substances will have to be evaluated by 2024.
Reminder on the Biocides Regulation (BPR)
The regulation on the placing on the market and use of biocidal products entered into force on September 1, 2013, under EU Regulation 528/2012.
Its objective is to ensure the marketing of biocidal products whose risks related to their use are controlled.
According to this regulation, a biocidal product is defined as a substance or mixture "intended to destroy, repel, render harmless, prevent the action of, or otherwise control harmful organisms by means other than simple physical or mechanical action.
There are 4 main groups of biocidal products, gathering 22 product types (TP): disinfectants, protection products, pest control products and other biocidal products. ECHA has made available a table of these biocidal products.
Support of EcoMundo
EcoMundo offers you several services:
- regulatory monitoring to stay up to date on the status of active substances and on new regulations via its MAT Factory software;
- traceability of your hazardous substances through its SVHC Factory software;
- calculation of the CLP hazard classification of your biocidal products through its SDS Factory software;
- in the submission of a biocidal active substance dossier or the creation of Product Authorization dossiers for biocides (PA) with its dedicated Biocides service.
EcoMundo also offers you the possibility to join a Biocides consortium.
Wish to know more about the biocidal products regulation?
For more information, do not hesitate to contact Cornelia Garaudel or one of our experts!
