During a September 2022 meeting, ECHA's Biocidal Products Committee (BPC) identified iodine and polyvinylpyrrolidone iodine (PVP) as endocrine disruptors (EDC). Thus, unless a dispensation is granted, it will not be possible to approve iodine-based products for use in the EU.
However, this opinion has not yet been processed by the European Commission, which will then issue a final decision, meaning that a final decision has not yet been issued.
What is the origin of this study?
Following a screening study in 2016, 3 substances were found to be potential endocrine disruptors according to the criteria for identification of endocrine disruptors in the BPR Regulation (EU) No 528/2012.
Thus, the EU authorities have taken the decision to launch reviews on the approval of these 3 biocidal active substances including iodine and polyvinyl pyrrolidone.
Studies were conducted in 2018 to determine the endocrine disrupting properties of these substances.
Which biocidal uses are concerned?
- For both iodine and polyvinyl pyrrolidone (PVP): disinfectants for veterinary hygiene (product type 3), for food and feed (product type 4) / wood preservatives (product type 8) / embalming and taxidermy fluids (product type 22)
What is the next step?
According to the European Commission, the primary next step is to replicate the studies that have been conducted along with an analysis of alternatives for these 2 substances and/or a risk assessment for their biocidal use.
The final decision on the approval of active substances and the authorization of these substances by the Union will be taken by the European Commission and the EU member states. According to BPC chairman Erik van de Plassche, ECHA is reportedly awaiting a mandate from the EU executive to review the risks associated with these substances.
What is the approval process for active substances?
In order to obtain authorization of use for a biocidal product, the active substances of the biocidal product must first be approved. For this purpose, an evaluation of the active substances is carried out by an evaluating Member State. The results of this evaluation are then forwarded to the Biocidal Products Committee (BPC) of ECHA, which issues an opinion within 270 days. The European Commission relies on this opinion for its decision to approve active substances. Note that an approval decision for an active substance is only valid for 10 years, after which the approval must be renewed.
The evaluation of active substances includes a section on formal exclusion and substitution criteria, introduced by the BPR (Biocidal Products Regulation). That is, an active substance meeting the exclusion criteria will not be approved, unless a dispensation is granted.
The criteria for exclusion are as follows:
- Carcinogenic, Mutagenic and Reprotoxic substances classified as category 1A or 1B substances according to the CLP regulation;
- Endocrine disruptors;
- Persistent, Bioaccumulative, and Toxic Substances (PBTs);
- Very Persistent and very Bioaccumulative Substances (vPvB).
A dispensation for use of a biocidal product containing substances that fall under the exclusion criteria may be granted only if the active substance is proven to be necessary for reasons of public health or public interest and if there are no other alternatives (Article 5(2) BPR). This must be demonstrated in a Product Authorization Dossier to be submitted and approved by an evaluating competent authority (eCA), in which case, the approval is granted for a maximum of 5 years.
When a substance is identified as being hazardous, alternative means must be considered, if it cannot be eliminated. In order for a substitution to be necessary, the substance must meet one of the following criteria:
- Meet at least one of the exclusion criteria listed above
- Be part of the respiratory allergens
- Have significantly lower toxicological reference values than most of the active substances approved for the same type of product and the same use
- Meet two of the criteria for being considered a PBT substance
- Be of concern to human or animal health and the environment (even with very restrictive risk management measures)
- Contain a significant proportion of non-active isomers or impurities
What we propose:
EcoMundo accompanies you in the submission of a biocide active substance file or the creation of a Product Authorization Dossier (PA) for biocides with its dedicated Biocides service.
EcoMundo also offers you the possibility to join a Biocides consortium.
During a September 2022 meeting, ECHA's Biocidal Products Committee (BPC) identified iodine and polyvinylpyrrolidone iodine (PVP) as endocrine disruptors (EDC). Thus, unless a dispensation is granted, it will not be possible to approve iodine-based products for use in the EU.
However, this opinion has not yet been processed by the European Commission, which will then issue a final decision, meaning that a final decision has not yet been issued.
What is the origin of this study?
Following a screening study in 2016, 3 substances were found to be potential endocrine disruptors according to the criteria for identification of endocrine disruptors in the BPR Regulation (EU) No 528/2012.
Thus, the EU authorities have taken the decision to launch reviews on the approval of these 3 biocidal active substances including iodine and polyvinyl pyrrolidone.
Studies were conducted in 2018 to determine the endocrine disrupting properties of these substances.
Which biocidal uses are concerned?
- For both iodine and polyvinyl pyrrolidone (PVP): disinfectants for veterinary hygiene (product type 3), for food and feed (product type 4) / wood preservatives (product type 8) / embalming and taxidermy fluids (product type 22)
What is the next step?
According to the European Commission, the primary next step is to replicate the studies that have been conducted along with an analysis of alternatives for these 2 substances and/or a risk assessment for their biocidal use.
The final decision on the approval of active substances and the authorization of these substances by the Union will be taken by the European Commission and the EU member states. According to BPC chairman Erik van de Plassche, ECHA is reportedly awaiting a mandate from the EU executive to review the risks associated with these substances.
What is the approval process for active substances?
In order to obtain authorization of use for a biocidal product, the active substances of the biocidal product must first be approved. For this purpose, an evaluation of the active substances is carried out by an evaluating Member State. The results of this evaluation are then forwarded to the Biocidal Products Committee (BPC) of ECHA, which issues an opinion within 270 days. The European Commission relies on this opinion for its decision to approve active substances. Note that an approval decision for an active substance is only valid for 10 years, after which the approval must be renewed.
The evaluation of active substances includes a section on formal exclusion and substitution criteria, introduced by the BPR (Biocidal Products Regulation). That is, an active substance meeting the exclusion criteria will not be approved, unless a dispensation is granted.
The criteria for exclusion are as follows:
- Carcinogenic, Mutagenic and Reprotoxic substances classified as category 1A or 1B substances according to the CLP regulation;
- Endocrine disruptors;
- Persistent, Bioaccumulative, and Toxic Substances (PBTs);
- Very Persistent and very Bioaccumulative Substances (vPvB).
A dispensation for use of a biocidal product containing substances that fall under the exclusion criteria may be granted only if the active substance is proven to be necessary for reasons of public health or public interest and if there are no other alternatives (Article 5(2) BPR). This must be demonstrated in a Product Authorization Dossier to be submitted and approved by an evaluating competent authority (eCA), in which case, the approval is granted for a maximum of 5 years.
When a substance is identified as being hazardous, alternative means must be considered, if it cannot be eliminated. In order for a substitution to be necessary, the substance must meet one of the following criteria:
- Meet at least one of the exclusion criteria listed above
- Be part of the respiratory allergens
- Have significantly lower toxicological reference values than most of the active substances approved for the same type of product and the same use
- Meet two of the criteria for being considered a PBT substance
- Be of concern to human or animal health and the environment (even with very restrictive risk management measures)
- Contain a significant proportion of non-active isomers or impurities
What we propose:
EcoMundo accompanies you in the submission of a biocide active substance file or the creation of a Product Authorization Dossier (PA) for biocides with its dedicated Biocides service.
EcoMundo also offers you the possibility to join a Biocides consortium.
