CA-March14-Doc.4.2-Final
Antifouling (PT21)
Way forward for the management of active substances and the authorisation of biocidal products
1.SUMMARY
During the 52nd, 53rd and 54thCA meetings, issues concerning the use of antifoulings, the review of these active substances, current national experience and practices, and finally possible risk mitigation measures applicable to these products were discussed.
In the light of these discussions, concernswere expressed regarding the risks associated with the use of antifoulings, as well as regarding the suitability of risk mitigation measures for these substances and products[1]. It was recognised that a specific strategy was needed to address these.
The following integrated approach is therefore suggested. It isbased on risk management measures developed and refined throughout the active substances’ approvals, the products authorisations, up to the renewals of the approvalsand authorisations.
2.STRATEGY
- Approval stage of active substances
Few active substances for PT21 are available today on the EU market. The first assessment reports of these substances show some unacceptable risks either for human health (ex: for the potman during a professional use), and/or for the environment (ex: in the harbour or marina during the service life, or during the application or maintenance and repair activities). The suitability of the proposed risk mitigation measures has raised questions, with no clear conclusions in the assessment reports. There is therefore a need to re-consider them at the product authorisation stage and to gain experience on the matter. Some risks accepted today by the majority of Member States (ex: levels of risks in the harbour or marina during the service life) might not be accepted anymore over the time.
Despite these concerns and risks arising from their use, antifouling products are nevertheless needed to prevent the growth of marine life on ships and boats allowing their safe and efficient operation. They participate to the prevention of spreading of invasive species, as well as reducing fuel, consumption and related greenhouse gases emissions.
Considering this situation, without prejudice to the general principles related to the application of the exclusion and substitution criteria of the BPR[2], it would be proposed:
To approve all active substances for PT21 on the basis on the same generic conditions. Additional specific conditions could be added on a case-by-case basis (for instance, if the substance is a skin sensitizer, the standard paragraph related to treated articles would be added).
To establish the same expiry date of approval for all existing active substances placed on the market for PT21, in order to evaluate the renewal of their approval at the same time.
To flag specific concerns related to each individual active substance in the assessment report.
a. Expiry date of approval of all existing antifouling active substances
The common date of expiry of the approval could be set on31/12/2025
Explanations for setting this date:
(1)The first PT21 active substances for which decisions are expected to be taken are zineb and DCOIT. The date of approval of these substances is expected to be 01/01/2016and the duration of approval 10 years. The expiry date of approval would thus be 31/12/2025.
(2)As discussed and agreed, if there is a need to perform comparison of the risks and benefits between active substances, and to verify the adequacy of risks mitigations measures, there would be an advantage to review the approval of the different active substancesat the same time, that is why the same expiry date of approval is proposed to be set for all PT21 active substances. This would also avoid the current situation currently faced with rodenticides where submission of applications for renewal will be spread between 2013 and 2015, and the earliest applications have to be put on hold until the last ones are submitted, in order to be able to review these active substances in parallel..
The following schedule can thus be expected:
(3)All draft CARs on existing active substances for PT21 will normally have been submitted by summer 2014 according to current plans of Rapporteur Member States (dCARs on copper compounds will be the last ones that are expected to be submitted, in the summer 2014).
(4)PT21 is part of the 1st priority list as agreed in document “CA-Sept13-Doc.8.3 - Final - Review programme of AS.doc”, and considering the estimated planning, all BPC opinions and EU decisions would be taken by end of 2015 on PT21 existing active substances, meaning that the latest date of approval would be around end of 2017 (for copper based compounds). Most antifouling products on the market are copper-based, and contain a co-biocide (i.e. one of the other active substances supported for PT21), which means that most antifouling products on the market would be subject to BPR authorisation onlywhen the decision would have been taken on copper compounds.
(5)As a consequence, considering the above mentioned schedule, the majority of applications for product authorisation would have been submitted by end of 2017 for existing products, and all decisions for authorisation should have been given by the end of 2019-2020.
(6)Except when the active substance will be targeted by substitution, authorisation of products will be granted for 10 years, until end 2029-2030.
(7)Formulators of biocidal products would therefore know well in advance what the conditions for the renewal of approval of the actives substances used in their products would be, if any. Indeed, the submission of the applications for renewal of product authorisation will be submitted a few years after the renewal of the active substances (renewal of the active substance would take place in 2025, and submission of the application for renewal of product authorisation would take place around mid-2028).
In addition, a study on comparative assessment and risk mitigation measures for antifouling products could be launched by the Commission in the next coming years (a similar study on the risks mitigation measures applicable to rodenticides PT14), to be taken into account for therenewal of approvalsand of authorisations.
The expected schedule can be summarized as follows:
[see next page]
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b. Specific conditions in approval regulations:
It is proposed to have the same generic conditions set out for all PT21 active substances. Additional specific conditions could be added on a case-by-case basis (for instance, if the substance is a skin sensitizer, the standard paragraph on treated articles would be added).
These standards generic conditions could be set as follows:
“The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.
Persons making products containing [the substance] available on the market for non-professional users shall make sure that the products are supplied with appropriate gloves.
This measure aims atspreading a standard good practice, which is to use antifouling products with gloves, whatever the level of risk.
This measure is however without prejudice to the provisions of paragraph 63 of Annex VI to BPR, whereby Member States shall normally not authorise antifoulings to the general public if the wearing of personnel protective equipment (PPE), such as gloves, is the only risk mitigation measure to reduce exposure to acceptable levels
Authorisations are subject to the following conditions:
(1)For industrial or professional users, safe operational procedures and appropriate organizational 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.
This measure aims at managing the risks for industrial / professional users when they apply the biocidal product
(2)Labels and, where provided, instructions for use shall indicate that children shall be kept away until treated surfaces are dry.
This measure aims at reducing potential exposure of children.
(3)Labels and, where provided, safety data sheets of products authorised shall indicate that application, maintenance and repair activities shall be conducted within a contained area,on an impermeable hard standing with bunding or on soil covered with an impermeable material to prevent losses and minimize emissions to the environment, and that any losses or waste containing [the substance] shall be collected for reuse or disposal.
This measure aims at managing the risks for the environment (soil organisms, groundwater, and run-off to surface water etc.)during the application, maintenance and repair activities when the biocidal product is applied.
(4)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[3] or Regulation (EC) No 396/2005 of the European Parliament and of the Council[4] shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.”
This measure aims at managing the potential uses where there might be a need to set or review existing MRLs (fishnets coatings, small professional boats used in mussels/oyster production, paints used to cover artificial ponds for growing fish/seafood products, etc…).
Additional provisions on a case-by-case basis:
These additional provisions would be added on a case-by-case basis, depending on the active substance and the risks linked to its use.
* For instance, the following provision will be added for all PT21 skin sensitizers (like zineb, DCOIT etc.. ), as this provision is addedfor all skin sensitizers:
“Where an article has been treated with or intentionally incorporates one or more biocidal products containing [the skin sensitizer substance], and where necessary due to the possibility of skin contact as well as the release of [the skin sensitizer substance] 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.”
This obligation will be applicable to “treated articles”[5] that are articles, as Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures already contains labelling provisions for mixtures containing skin sensitizers.
c. Specific concerns identified on individual active substances
Specific concerns related to each active substance to be taken into account at the product authorisation stage would be listed into the assessment report, in particular in section 3.3.
In addition, the possible risks mitigation measures proposed would be also summarised in each assessment report, in the elements to be taken into account at the product authorisation stage. This could include, among others:
Recall of the obligations to apply provisions coming from the IPPC rules for marina, harbour or yachting areas.
Implementation of a specific area for paint application (ex: signals to inform bystanders, restricted area for professional application, etc.).
For shrouding,application on hard standing or protection of the application area with impermeablematerial(ex: plastic tarpaulin) or foils and/or fine meshed nets.
Thorough cleaning of dock floor with collection of solids and wastewater (ex: yachts and commercial ships).
Good spraying practices such as good maintenance and control of sprayers by trained people, taking into account wind speed and direction (professional application to yachts and commercial ships).
Information to be provided to the users of painted boats, in case there are some restrictions for the service-life of the paint (ex: for instance, if the paint is meant for a use on boats that will travel only in specific seas).
The control and monitoring of the implementation of all these risks mitigation measures should be part of the control plans of Member States. The experience gained on the matter will have to be taken into account for the day-to-day authorisation of these biocidal products, as well as for the review of the approval of the active substances.
- Authorisation and mutual recognition of biocidal products
As far as possible, decisions of authorisation of antifouling products should be harmonised. So far, there seems to be nogrounds for Member States to implement different risks mitigation measures or decisions for:
- the protection of human health, in relation to :
- the protection of professionals.
- the protection of environment, in relation to :
- the risks related to the in-service life of antifoulings applied on large commercial boats or superyatch >25m where these vessels are expected to travel across EU. Indeed, if a product is authorised in one Member State, and the product is applied in this Member State, the treated boat can afterwards travel across EU, and harmonisation is therefore needed.
On the other hand, on duly justified grounds, Member States could request derogationfrom mutual recognition and decide to refuse to grant or restrict the use of antifouling productson either commercial or pleasure boats at regional/local levels in accordance with Article 37 of the BPR, for instance to ban the use in sensitive areas, specific marinas, specific coastal zones etc.
Member States, which already have national policies, practices or specificities which would possibly lead them to refuse to authorisation or restrict the use antifouling products in accordance with Article 37, are invited to share that information with the other Member States and the Commission, as it would help to anticipate on issues that could arise at the time of mutual recognition of authorisations.
- Treated articles
It has to be noted that boats are “treated articles”, as they has been treated with a biocidal product (i.e. the antifouling paint). Boats that are placed on the market (i.e. first making available on the EU market according to Article 3(1)(j)) have to comply with provisions of the BPR. So is the same with fishnets or other aquaculture equipment that would have been treated with an antifouling.
3.Further works
Additional technical issues might need further discussion, in particular in the BPC and its workings groups (ex: use of regional marina scenarios, development of marina scenarios for freshwaters, efficacy etc.).
An analysis of the risk mitigation measures applied for antifouling products (similar to the study on the risks mitigation measures applicable to rodenticides PT14) would be useful for the purpose of the renewal of substance approvals and product authorisations.
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[1]European Environmental Agency Report 1/2013, Late lessons from early warnings II : science, precaution, innovation ; Chapter 12 - Booster biocide antifoulants: is history repeating itself (
[2]See document on the principles for approval of the active substances endorsed CA-March14-Doc.4.1 - Final - Principles for substance approval.docat55thCA meeting, according to which the approval of certain substancescould still be refused, or reduced to less than 10 years, if those substances fulfilled exclusion or substitution criteria.
[3]OJ L 152, 16.6.2009, p. 11.
[4]OJ L 70, 16.3.2005, p. 1
[5] See Article 3(1)(l) of BPR : ‘treated article’ means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.