/ EUROPEAN COMMISSION
HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL
Safety of the food chain
E.3 - Pesticides and Biocides

61stmeeting of representatives of Members States Competent Authorities for the implementation of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products

Subject:Wording of the conditions of approval of active substances

  1. Purpose of the note

With the progression of the review programme and the variety of uses within product-types now coming to a decision, the drafting of specific conditions to be included in the approval regulations has become very complex and challenging, as they also touch on both biocidal products and treated articles.

The objective of this note is to discuss the current approach and propose an alternative one for the sake of simplification, clarity and efficiency, without hampering the objectives of the BPR or reducing the level of protection of human health, animal health and the environment.

  1. Analysis of the current practice and discussion

At the time ofthe first decisions on the inclusion of active substances into Annex I or IA of Directive 98/8/EC, a general approach was agreed with regard to the level of detail of conditions to be set in approval decisions[1]. A distinction was made between uses which have been evaluated and found to be unacceptable,and those to be acceptable only provided that certain conditions would beobserved.In that latter case, measures were designed inorder tolist precisely the risks which had been identified, as well as the possible risk mitigation measures, most of the time with an "unless clause" leaving open the possibility for companies to demonstrate a safe use at product authorisation.

Although this approach has fulfilled its objective, its implementation is becoming more and more challenging with the progression of the review programme and the variety of uses within product-types now coming to a decision.

Opinions of the Biocidal Product Committee (BPC) are highly dependent on the number of representative uses provided in the application by the participant in the review programme, the approach taken by the Rapporteur Member State in its own assessment, and the debate taking place during the peer review process.

In many cases, the measures recommendedunder section 2.3 of BPC opinions contain an "unless clause"[2]. In those cases, measures recommended are not really restrictions, as applications for product authorisation are still possible, and full evaluation of the biocidal product would then be performed before deciding on the conditions of its authorisation. Prospective applicants have the possibility to provide new dataat product authorisation for that use, which might demonstrate that the level of risk is acceptable or that the risk mitigation measures identified during the substance evaluation are not relevant for its product. Besides, other risks mitigation measures than the one(s) identified at the approval stage may be proposed by applicants at the product authorisation stage.

Experience has shown that the drafting of these measures can be complex, sometimesvery detailed or specific, and not always consistent across active substances.

Moreover, the subsequent drafting of the approval decisions has also become more complex and time consuming, whilst providing little added value.

This complexity and level of detail is however the consequence of the BPC having followed the approach described above when providing its recommendations.

Against this background, the Commission is therefore of the opinion that simplification is needed, without hampering the objectives of the BPR or reducing the level of protection of human health, animal health and the environment.

  1. New approach

To address the above-mentioned concerns, it is proposed that the drafting of approvaldecisionsshould follow the following principles[3] :

  1. When the nature and/or severity of the risk may be such that the use should be restricted, arestriction is clearly set on thatuse :

Ex: "Products shall not authorised for outdoor use", "Product shall be restricted to professional users" (ex: gas used for fumigation), "Products shall not be authorised or used to control the growth and settlement of fouling organisms on freshwater going vessels", etc.

  1. When a risk has been identified for a usercategory/population, or an environmental compartment, BUT the possibility is left open to demonstrate a safe use at product authorisation stage (i.e. because it may be possible to demonstrate a safe use by submitting data or introducing risk mitigation measures), the approach taken so far shall be simplified :

–Measures with "unless clause" shall no longer be used in approval regulations.

–Measures shall no longer specify the possible risk mitigation measures.

–Measures shall be more general and drafted as follows:

"The product assessment shall pay particular attention to the possible risks to [indicate the user category/population and/or the environmental compartment at risk, as well as the use related to this risk described in a general way.]"

However, theidentification of the possible risk mitigation measurescould still be indicated in the BPC opinions, to facilitate the product authorisation stage.In such case, they would need to be included in section2.4 of BPC opinions "Elements to be taken into account when authorising products".

This approach is consistent with the one taken for plant protection products under Regulation (EU) No 1107/2009 for the approval of active substances, where a simpler approach is followed for the drafting of approval measures[4].

  1. Conclusion

This proposal is aimed at facilitating the process of establishing the recommendations for approval by the evaluating Member State and the BPC, and consequently saving time for the preparation of the approval Regulations by the Commission and the decision making process within the Standing committee on biocidal products.

It will also contribute to make the approval Regulations simpler, easier to understand and to implement.

Upon agreement, the new approach shall be taken into account by the BPC in the drafting of its opinions.

The Commission invites Member States' Competent authorities to reflect on this proposal in order to have a discussion during the CA meeting.

1

APPENDIX I

The following tables present an a comparison between BPC opinion and provisions set in the approval regulation, to illustrate cases where the BPC recommendations had to be analysed and had to be redrafted substantially in the approval regulation, to illustrate cases where the conditions are complex and detailed.

1. Cases where the BPC opinions were not totally fit for purpose, and extensive work has been neededto draft the approval regulation from the BPC opinions

Substance / PT / Recommendations in the BPC opinion in section 2.3 / Measures in the approval Regulation (or draft approval) / Comments
Most substances / Various / Lack of indication in the conclusions to easily identify the nature of the risk which generated the recommendation / Addition of the user/population or environmental compartment at risk for each of the measures / To go from the opinion to the draft approval regulation, additional work has been necessary to identify the motive of the recommendation
Several substances : folpet, MBM, etc… / Various / Various types of proposals related to treated articles / Standard provisions as agreed in July 2015 / This difference across opinions, and between opinions and approvals, was due to on-going discussions related to the provisions on treated articles
Glutaraldehyde / 6 /
5. Glutaraldehyde shall not be used in treated articles, or in biocidal products intended for non-professional users at a concentration equal to or higher than 0.1% unless safe use can be demonstrated by other means than PPE.
7. Products shall not be authorized for the preservation of drilling and cementing fluids unless it can be demonstrated that the product will not lead to an unacceptable risk. / The authorisations of biocidal products are subject to the following conditions:
[...]
(2) In view of the risks to human health, products intended for non-professional users shall not contain glutaraldehyde at a concentration triggering classification as skin sensitiser, unless exposure can be reduced to an acceptable level by other means than the wearing of personal protective equipment.
(3) In view of the risks to the environment, products shall not be authorized for preservation of drilling and cementing fluids unless it can be demonstrated that risks can be reduced to an acceptable level.
[...]
The placing on the market of treated articles is subject to the following conditions:
(1) Mixtures treated with or incorporating glutaraldehyde shall not contain glutaraldehyde at a concentration triggering classification as skin sensitiser, unless exposure can be reduced to an acceptable level by other means than the wearing of personal protective equipment.
[...] / To go from the opinion to the draft approval regulation, additional work has been necessary to :
- distinguish the provisions on biocidal products, and the provisions on treated articles
- provisions related to the concentration in treated articles were considered only relevant to mixtures and not all treated articles
Potassium sorbate / 8 /
5. For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council or Regulation (EC) No 396/2005 of the European Parliament and of the Council shall be verified, and any appropriate risk mitigation measures shall be taken into account to ensure that the applicable MRLs are not exceeded. / No need for a measure on MRL / To go from the opinion to the draft approval regulation, additional work has been necessary to remove the provisions on MRL, which was not put for any other PT08 substance, and not relevant as potassium sorbate is also a food additive E202. This provision could have given the impression of a particular concern, although no specific concern was identified in the assessment.

2. Cases where BPC opinions and approval regulations contain a high level of details, most of the time on measures with "unless clause"

Substance / PT / Recommendations in the BPC opinion in section 2.3 / Measures in the approval Regulation (or draft approval) / Comments
Several substances / Various / - / - / During the BPC discussions on some substancesfor PT3 or PT6 for instance, discussions took place on the level of detail in the recommendations for approval, for instance on the reference to the type of cattle housed in the stables, on the various uses of can-preservation, or the size of the buildings where the disinfection takes places etc.
CMIT/MIT / 6 / 3. For industrial and professional users, safe operational procedures, appropriate organisational and technical risk mitigation measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment.
4. For non-professional users, the concentration of C(M)IT/MIT in treated articles shall not exceed the threshold value set for sensitizing properties.
5. For professional users, the concentration of C(M)IT/MIT in liquid detergents shall not exceed the threshold value set for sensitizing properties unless exposure can be avoided by other means than PPE. However, for other treated articles, this provision shall also apply if risk mitigation measures including wearing of PPE are not sufficient to avoid exposure during the use of the treated articles.
6. Biocidal products containing C(M)IT/MIT shall not be used to preserve pulp and paper processing fluids, unless it can be demonstrated at product authorisation that risks to the environment can be reduced to an acceptable level.
7. Where a treated article has been treated with or intentionally incorporates one or more biocidal products containing C(M)IT/MIT, and where necessary due to the possibility of skin contact as well as the release of C(M)IT/MIT under normal conditions of use of the article, the person responsible for placing the article on the market shall ensure that the label provides information on the risk of skin sensitisation, as well as the information referred to in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012. / The authorisations of biocidal products are subject to the following conditions:
(1) For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.
(2) In view of the risks to the environment, biocidal products shall not be used to preserve pulp and paper processing fluids, unless it can be demonstrated that risks can be reduced to an acceptable level.
The placing on the market of treated articles is subject to the following conditions:
(1) In view of the risks identified for human health, mixtures treated with or incorporating C(M)IT/MIT and placed on the market for use by the general public shall not contain C(M)IT/MIT at a concentration triggering classification as skin sensitizer, unless exposure can be avoided by other means than the wearing of personal protective equipment.
(2) In view of the risks identified for human health, liquid detergents treated with or incorporating C(M)IT/MIT and placed on the market for use by professional users shall not contain C(M)IT/MIT at a concentration triggering classification as skin sensitizer, unless exposure can be avoided by other means than the wearing of personal protective equipment.
(3) In view of the risks identified for human health, mixtures treated with or incorporating C(M)IT/MIT, other than liquid detergents, and placed on the market for use by professional users shall not contain C(M)IT/MIT at a concentration triggering classification as skin sensitizer, unless exposure can be avoided, including by the wearing of personal protective equipment.
(4) The person responsible for the placing on the market of a treated article treated with or incorporating C(M)IT/MIT (3:1) shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012. / The recommendation for approval in the BPC opinion is very specific on the use assessed, referring to "liquid detergent".
Such opinion/approval could mislead readers as it might give the impression that all the uses were assessed, although only a few uses were assessed. It can also give the impression that other uses might not pose a risk, which might not be the case.
CMIT/MIT / 11 / 3. For professional users, safe operational procedures, appropriate organisational and technical risk mitigation measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment.
4. Products should not be authorized for uses in photographic processing liquid, in wood treatment solution preservatives and large open recirculating cooling systems unless it can be demonstrated at product authorization that risks to environment can be reduced to an acceptable level.
5. Unless it can be demonstrated at product authorisation that risks to the environment can be reduced to an acceptable level, labels and, where provided, safety data sheet of products shall indicate that:
a. For the use in small open recirculating cooling systems, risk mitigation measures as drift eliminator should be in place to reduce the direct contamination of terrestrial compartment via air deposition.
b. For other uses than those specified under provision 4, release of waste water from the facilities should be directed to a sewage treatment plant. / The authorisations of biocidal products are subject to the following conditions:
(1) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.
(2) In view of the risks identified for the environment, products shall not be authorized for the preservation of photographic processing liquid, of wood treatment solution and for the use in large open recirculating cooling systems unless it can be demonstrated at that risks can be reduced to an acceptable level.
(3) In view of risks identified for the environment, and unless it can be demonstrated that risks can be reduced to an acceptable level, labels and, where provided, safety data sheet of products shall indicate that:
a. For uses in small open recirculating cooling systems, risk mitigation measures shall be in place to reduce the direct contamination of terrestrial compartment via air deposition.
b. For uses other than those specified under provision n°2, release of waste water from the facilities shall be directed to a sewage treatment plant.
The placing on the market of treated articles is subject to the following condition:
The person responsible for the placing on the market of a treated article treated with or incorporating C(M)IT/MIT (3:1) shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012. / The recommendations for approval in the BPC opinion are very specific on the use assessed, referring to photographic processing liquid, wood treatment solution preservatives, large open recirculating cooling towers.
Such opinion/approval could mislead readers as it might give the impression that all the uses were assessed, although only a few uses were assessed. It can also give the impression that other uses might not pose a risk, which might not be the case.
Folpet / 6 / 3. For industrial users, safe operational procedures and appropriate organisational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, biocidal products shall be used with appropriate personal protective equipment.
4. Labels and, where provided, safety data sheets of biocidal products authorised for the preservation of paints, films or coatings used for outdoor application by brush shall indicate that measures shall be taken to protect the soil to prevent losses and minimise emissions to the environment, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level by other means.
5. Biocidal products shall not be authorised for the preservation of paints, films or coatings used for outdoor application by spraying, unless it can be demonstrated in the application for product authorisation that risks for the soil compartment can be reduced to an acceptable level.
6. Due to the risks identified for the soil compartment the label and where provided the Safety Data Sheets of paints, films and coatings for outdoor use preserved with folpet shall indicate that they shall not be applied outdoors by spraying, and that measures shall be taken to protect the soil when they are applied by brush, unless it can be demonstrated that risks can be mitigated by other means.