annual report 2018 - anses · (radiofrequencies, electromagnetic fields related to high-voltage...

PLANT PROTECTION PRODUCTS, FERTILISERS, GROWING MEDIA, ADJUVANTS AND BIOCIDAL PRODUCTS

ANNUAL REPORT 2018

Review of ANSES’s 2018 activities in risk assessment, issuing of marketing authorisations and permits, and phytopharmacovigilance

ANNUAL REPORT 2018

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CONTENTS

Introduction 4

The principles that frame ANSES’s work in the area of plant protection products, fertilisers, growing media, adjuvants and biocidal products 6

Dossier assessment activities 8

Four types of products to be assessed and as many regulatory frameworks 9

Assessment of active substances 9

Scientific assessment of marketing authorisation applications 10 Implementation of methodological developments and production of useful data for the assessment 11

Activities in issuing, amending and withdrawing marketing authorisations for products 12

Activities relating to plant protection products, fertilisers and growing media 13

Activities relating to biocidal products 13

The Marketing Authorisations Monitoring Committee: support for decision-making 13

Inspection and monitoring of plant protection products, fertilisers and growing media 15

ANSES’s work in the area of plant protection products, fertilisers and growing media in 2018 17

In 2018, ANSES continued its efforts to facilitate the marketing of biocontrol products 18

Improving information and dialogue with stakeholders 20

ANSES’s work in the area of biocidal active substances and products in 2018 22

Phytopharmacovigilance 24

The network of partners in phytopharmacovigilance 25Collection and investigation of reports of adverse effects: improved tools for collection and monitoring 25Summarised reviews of knowledge for the assessment of plant protection products 26Studies to consolidate partner schemes, generate new knowledge, and review reports 27

The Agency’s other activities in the area of regulated products 28

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INTRODUCTION

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THE PRINCIPLES THAT FRAME ANSES’S WORK IN THE AREA OF PLANT PROTECTION PRODUCTS, FERTILISERS, GROWING MEDIA, ADJUVANTS AND BIOCIDAL PRODUCTS

After a reminder of the principles that frame ANSES’s work in the area of plant protection and biocidal products, fertilisers and growing media, and of the procedures for assessing and issuing marketing authorisations for these products, this report presents the work conducted by the Agency on this topic in 2018, including in the area of phytopharmacovigilance.

ANSES’s sphere of competence is vast, since in addition to food safety, it is responsible for risks in the areas of environmental and occupational health, human health, animal health and welfare, and plant health. It works on all types of risks, whether microbiological (food, air, water), chemical (assessment of plant protection products, biocides, veterinary drugs, endocrine disruptors, air pollution, etc.) or physical (radiofrequencies, electromagnetic fields related to high-voltage lines, noise, etc.).

At ANSES, the risks and effectiveness of plant protection and biocidal active substances and products are assessed both before and at the time the products are placed on the market, or through post-authorisation monitoring of their impact. This assessment is part of a comprehensive approach that is inseparable from the monitoring of residues of these substances in food and the environment and, more broadly, their impact on health, the environment and biodiversity.

In 2015, the Agency was entrusted with establishing a phytopharmacovigilance scheme, and with granting, amending and withdrawing marketing authorisations (MAs) for plant protection products, fertilisers and growing media. In 2016, this responsibility was extended to MAs for biocidal products.

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Under Article L. 1313-3-1 of the French Public Health Code, the French Agency for Food, Environmental and Occupational Health & Safety prepares a report each year, addressed to Parliament, giving an account of its activities: 1. In the framework of its missions relating to plant protection products, adjuvants, fertilisers and

growing media, laid down in the tenth paragraph of Article L. 1313-1; 2. In the framework of its risk monitoring missions, in particular as part of the phytopharmacovigilance

scheme, laid down in Article L. 253-8-1 of the French Rural and Maritime Fishing Code;3. In the framework of its missions relating to biocidal products, laid down in the eleventh paragraph

of Article L. 1313-1.

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the independence and rigour of ANSES’s scientific expert appraisal, as well as the functional separation of assessment and management. The Regulated Products Assessment Depart-ment (DEPR) assesses the hazards and risks to humans, animals or the environment of products, as well as their effectiveness. The Market Authorisations Department (DAMM) receives dossiers and verifies their admissibility, and examines applica-tions for MAs and permits. The Deputy Director General coordi-nates this work and ensures that it is in step with the monitoring and vigilance activities mentioned in the next point;

strengthening of the means for detecting warning signals and alerts relating to any adverse effects or non-compliances of these products, in particular through implementation of the phytopharmacovigilance scheme, the links with the toxicovigi-lance scheme – which is now coordinated by ANSES – and the means of inspection and control;

a capacity for funding independent studies in the framework of phytopharmacovigilance, financed by a tax on plant protec-tion products, or more broadly in the context of the scientific and technical research programmes funded by ANSES.

All these activities have undergone ISO 9001 certification, renewed for ANSES at the end of 2016 and subject to a follow-up audit in 2018, and which covers the authorisation and control of plant protection products and fertilisers. These activities are therefore covered by a quality process that guarantees traceabi-lity, takes risks into account and ensures management based on indicators. Lastly, in the interests of transparency, all decisions are published on the Agency’s website, along with the findings of the assessment on which they are based. The information contained in the MA decisions on products is also provided on the Agency’s dedicated «E-Phy» website, the catalogue of plant protection products and their uses, fertilisers and growing media authorised in France. For biocides, the list of products authorised in Europe in accordance with Regulation (EU) No 528/2012 is available on the register for authorised biocidal products managed by ECHA via the R4BP platform.

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ANSES exercises its missions in the area of plant protection products and biocides, adjuvants, fertilisers and growing media in compliance with the European and national regulatory frameworks, and while guaranteeing application of the following principles:

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ANNUAL REPORT 2018

DOSSIER ASSESSMENT ACTIVITIES

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FOUR TYPES OF PRODUCTS TO BE ASSESSED AND AS MANY REGULATORY FRAMEWORKSThe Regulated Products Assessment Department (DEPR) has the following missions, within the framework of European and national regulations:

assessment of the hazards and risks to humans, animals or the environment, as well as the agronomic benefits, of plant protec-tion substances and products (Regulation (EC) No 1107/2009);

assessment of the hazards and risks to humans, animals or the environment, as well as the effectiveness, of biocidal substances and products (Regulation (EC) No 528/2012);

assessment of fertilisers, adjuvants for fertilisers and growing media, in accordance with the provisions of the French Rural and Maritime Fishing Code, and in the context of European Regula-tion (EC) No 2003/2003.

Lastly, non-indigenous macro-organisms beneficial to plants and introduced into the environment are also assessed by the DEPR in accordance with the provisions of the French Rural and Maritime Fishing Code.

The general purpose of these regulations is to ensure a high level of protection for humans, animals and the environment by only placing on the market those products that are effective and do not have adverse effects on human health or entail unaccep-table risks to the environment and the organisms it harbours.

For plant protection products and biocides:

Active substances are assessed at European level, leading to an approval regulation if the active substance fulfils the condi-tions for approval of the European regulations. The European

Commission has drawn up a positive list of active substances approved at EU level;

Once the active substance(s) they contain have been appro-ved, the products undergo a zonal1 or EU assessment prior to national marketing authorisation being granted.

ASSESSMENT OF ACTIVE SUBSTANCESActive substances are assessed from three angles:

assessment of the hazard intrinsic to the active substance;

assessment of exposure, and risks resulting from this expo-sure, under the proposed conditions of use, to humans and the environment for one or more representative uses;

assessment of the substance’s effectiveness.

Approval of plant protection active substances, whether they are microbiological, chemical, synthetic or natural, falls within the remit of the EU, following an opinion by the European Food Safety Authority (EFSA). ANSES participates, as a Rapporteur Member State, in the assessment of these substances, in the framework of EFSA’s work. The timetable for re-examinations and the distribution of the substances to be assessed between the various Member States are decided at EU level.

The EU has competence for the approval of biocidal active substances, which is granted after an opinion by the European Chemicals Agency (ECHA). The biocidal active substance can be a chemical compound or derived from a micro-organism exer-cising its biocidal action on or against the harmful organisms. Moreover, in the field of biocides, there are 22 types of biocidal products divided into four groups:

1 Under Regulation (EC) No 1107/2009, Europe has been divided into three zones: north, centre and south, within which Member States can rely on the assessment carried out by another Member State (Rapporteur Member State) to authorise a product used outdoors. For products used under shelter, the assessment may be shared throughout the EU.

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Disinfectants (human or animal hygiene, disinfection of surfaces, disinfection of drinking water, etc.);

Preservatives (for products during storage, wood preserva-tives, construction material preservatives, etc.);

Pest-control products (rodenticides, insecticides, repellents, etc.);

Other biocidal products (embalming fluids, antifouling products, etc.).

Approval of a biocidal active substance is established for one or more product types. The assessment therefore focuses on an active substance-product type combination, and assesses the risks and effectiveness for representative uses of the product type concerned.

ANSES participates as a Rapporteur Member State in the assess-ment of biocidal and plant protection active substances, in the framework of the EU assessment of dossiers. ANSES also takes an active part in the comment phase and in discussions of the draft assessment reports submitted by the other Member States and, for biocides, in the drafting of opinions by ECHA’s Biocidal Products Committee.

SCIENTIFIC ASSESSMENT OF MARKETING AUTHORISATION APPLICATIONSThe assessment of applications for plant protection products, biocidal products, fertilisers and growing media relies on a scientific examination of the dossier, which is essentially carried out at European, zonal or national level depending on the regulations concerned. It consists of a thorough review of the product’s physico-chemical properties, the risks to human health, fauna, flora and different environmental media, as well as an assessment of the product’s effectiveness.

This assessment is based on the studies provided by the appli-cant, the most recent scientific literature and, for MA renewals, observation data on the impact of these products collected as part of the phytopharmacovigilance scheme. The findings of the assessment are then submitted to a committee of independent external experts. Four expert committees, each specific to a substance or product type, contributed to ANSES’s assessment work in 2018:

plant protection products: chemical substances and prepa-rations;

micro-organisms and macro-organisms beneficial to plants;

fertilisers and growing media;

biocidal substances and products.

The findings of the assessment in French, published on the Agen-cy’s website, summarise the results concerning the hazards.

(including toxicological classification for human health and the environment) and risks to humans, animals or the environment, as well as the effectiveness of the products in question for the claimed uses. The conditions of use for which the assessment has been carried out are also specified (doses, conditions of application, targets, etc.).

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IMPLEMENTATION OF METHODOLOGICAL DEVE-LOPMENTS AND PRODUCTION OF USEFUL DATA FOR THE ASSESSMENTThe Agency’s scientists working to assess plant protection products, fertilisers and biocides are involved in a wide range of activities aimed at developing or optimising assessment methodologies, as well as drafting and developing harmonised guidelines for the examination of dossiers in accordance with European regulations. This work is most often undertaken in partnership with other organisations or in the framework of national, European or international working groups. Its purpose is not only to enhance the interpretation of assays used to deter-mine chemical hazards, but also to construct detailed exposure scenarios and models used in assessing hypothetical risks and agricultural benefits.

When carrying out its assessment missions, in addition to the information present in the dossiers submitted by the applicants, ANSES may identify additional data needed for effectively conducting the assessment of certain dossiers, or for proposing changes to assessment methods and practices. These data most frequently concern contamination of the environment, human exposure to the products concerned, or the risks to humans and the environment associated with the products’ uses. ANSES also funds specific studies to encourage the production of new knowledge needed for its expert appraisals. Some of these studies, dealing with the adverse effects of the products concer-ned, are made possible thanks to the financing put in place as part of the phytopharmacovigilance scheme (see below), while others fall within the general framework of the scientific and technical research programmes funded by ANSES.

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ACTIVITIES IN ISSUING, AMENDING AND WITHDRAWING MARKETING AUTHORISATIONS FOR PRODUCTS

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ACTIVITIES RELATING TO PLANT PROTECTION PRODUCTS, FERTILISERS AND GROWING MEDIADecisions regarding the issuing, amendment and withdrawal of marketing authorisations are examined by the Market Authori-sations Department (DAMM) and submitted to ANSES’s General Directorate for a final ruling.

As the interface with applicants, the DAMM is in charge of receiving applications and dossiers relating to plant protection products and fertilisers, or active substances, and reviewing the decisions on marketing authorisations and permits related to these products. It rules on the admissibility of the applica-tions and the completeness and categorisation of the dossiers received, and provides information that helps to place the appli-cations in context: agronomic context and conditions of use of the products, as well as analytical information for the compara-tive assessment of products in application of Article 50 of Regu-lation (EC) No 1107/2009, for the submission of dossiers concer-ning active substances that are candidates for substitution.

Applications of an administrative nature, which do not require a scientific assessment and which in 2018 accounted for around 50% of applications, are processed directly by the DAMM.

The department also examines applications for experimen-tation permits and manages declarations of trials and experi-ments for the products in question, using the dedicated SIDEP online reporting service launched by ANSES in April 2017. These declarations are made by the service providers or approved companies, either before the trial is set up, as part of waivers for experimentation permits, in application of the Order of 6 February 2016, or after the experiment has been established in the context of officially recognised trials.

With the examination of parallel trade permits, the DAMM acts as the interface with the other Member States for the transmis-sion of information needed for this examination, as well as for updating the list of products whose introduction is authorised for personal use, in application of Article R. 253-27 of the French Rural and Maritime Fishing Code.

Decisions relating to marketing authorisations (authorisation, amendment, refusal or withdrawal) and permits are reviewed by the DAMM taking into account not only the results of the scientific assessment, but also the agronomic context in which the product is used, and/or the existence and characteristics of other products available on the market.

The Department also manages the MA Monitoring Commit-tee (point 4.3) and implementation of the inspection activities entrusted to ANSES under the Act on the future of agriculture, adopted in late 2014 (point 4.4).

ACTIVITIES RELATING TO BIOCIDAL PRODUCTSAt national level, ANSES assesses the hazards, risks and effective-ness of biocidal active substances and products for which appli-cation dossiers have been submitted in France, in accordance with the criteria defined by the European regulations. Marketing authorisations (MAs) are then issued on the basis of this scien-tific assessment of the effectiveness and risks of the products. In application of the Act of 2 December 2015 concerning various provisions for adapting to European Union law, ANSES has also been tasked with issuing, withdrawing and amending MAs for biocidal products, in accordance with European Regulation (EU) No 528/2012. The Agency also has responsibility for declarations to the biocidal products inventory (SIMMBAD).

The organisation put into place takes into account the speci-fic features of the European regulations governing biocidal products while guaranteeing the independence of the assess-ment and at the same time safeguarding the Agency’s ability to effectively support its positions in assessment and manage-ment in the framework of the European procedure.

Indeed, biocidal products have certain specific features that impact ANSES’s organisation and work in examining these dossiers:

a very broad field of products and uses,

very tight regulatory deadlines,

a European procedure that simultaneously addresses issues relating to assessment and management, and in which mutual recognition is predominant. Great importance is thus attached to the collegial review of dossiers between Member States, and efforts are systematically made to harmonise conditions of use and management measures before the decision is made.

THE MARKETING AUTHORISATIONS MONITORING COMMITTEE: SUPPORT FOR DECISION-MAKING When reviewing decisions relating to marketing authorisations, the Director General may call on the Marketing Authorisations Monitoring Committee, established by the Act on the future of agriculture and whose scope was broadened to include biocidal activities.

Made up of 11 to 18 individuals with knowledge and experience of field practices and issues relating to the implementation of MAs, this Committee may be consulted by the Agency’s Director General on the conditions under which the marketing authori-sations will be implemented (Art. L. 1313-6-1 of the Public Health Code) and more specifically on:

the conditions of applicability of risk management measures as regards marketing authorisations;

the safety of use of products with regard to human health, animal health and the environment;

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the agronomic and socio-economic benefits of the different plant health solutions available in accordance with the prin-ciples of agroecology, including biocontrol solutions;

the health, environmental and socio-economic benefits of certain biocidal products and their conditions of use;

the use of signals collected as part of phytopharmacovigilance and toxicovigilance;

the identification of priority topics in terms of studies to be conducted relating to the use of plant protection products and their adjuvants, fertilisers and growing media and their adju-vants, and biocidal products;

the identification of priority topics concerning monitoring of the production, formulation, packaging and labelling of plant protection products and their adjuvants, fertilisers and growing media and their adjuvants.

The minutes of these meetings are made publicly available on the Agency’s website. The Monitoring Committee was convened three times in 2018 and issued opinions on:

the feasibility of management measures on the depth at which granules should be buried;

the placing on the market of fertilisers containing symbio-tic bacteria of soybeans: agronomic impact, conditions of use, management measures and available information;

management measures for the protection of residents and bystanders;

management measures limiting the transfer of prosulfocarb products to non-target crops.

The competence of the MA Monitoring Committee was extended to biocidal products in 2018, with new members being introduced at the committee meeting in September 2018, to enable this body to be consulted on issues relating to these products.

Lastly, the committee was renewed at the end of its first three-year term of office by Inter-ministerial Order of 14 December 2018. Work on this second term will begin in February 2019.

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INSPECTION AND MONITORING OF PLANT PROTECTION PRODUCTS, FERTILISERS AND GROWING MEDIAThe Agency has an inspection mission with regard to the produc-tion, formulation, packaging and labelling of plant protection products, adjuvants, fertilisers and growing media.

These activities are carried out under a memorandum of unders-tanding signed in 2015 between the Directorate General for Food (DGAL), the Directorate General for Competition, Consu-mer Affairs and Fraud Control (DGCCRF) and ANSES, with the aim of ensuring that the different inspection and control bodies under these administrations and ANSES work in a coordinated manner, with exchanges of information on annual plans and their reviews, but also on the establishments visited, in conjunc-tion with the regional directorates for food, agriculture and forestry (DRAAF/SRAL2) and the departmental directorates for the protection of populations (DDPP), in order to avoid succes-sive controls by several inspection bodies.

Many inter-service exchanges were developed with the signato-ries of the MoU, as well as with the customs authorities (DGDDI/DNRED3) and the DGAL/ BNEVP4, with the communication of information relating to the decisions, the conditions of use and applications of the products, or their labelling.

In 2018, the inspection activity refocused its checks on formula-tion/packaging/labelling establishments, in order to verify the traceability of product composition and formulation, as well as their labelling after production, and on the implementation of new control methodologies (37 control criteria for labelling and packaging, and over 47 criteria for formulation).

The main activity was providing support for the various govern-ment departments in charge of product inspection, with 169 requests from control services processed (DGAL/DRAAF: 104; DGAL/BNEVP: 8; DGCCRF: 49; DNRED: 5; National Gendarme-rie: 1). In addition, at the end of 2018, one establishment was inspected for the formulation, packaging and labelling of two plant protection products. Of all the criteria checked, only one minor non-compliance was found.

2018 SUMMARY OF DECISIONS RELATING TO AUTHORISATIONS AND EXPERIMENTATION PERMITS FOR PLANT PROTECTION PRODUCTS, ADJUVANTS, FERTILISERS AND GROWING MEDIA.

Major dossiers (MAs,

re-examinations, extension of

major uses)

Other dossiers with

assessment

Administrative dossiers

Parallel trade permits

Adjuvants Fertilisers & growing

media

Experimentation permits

1000900800700600500400300200100

0

204

338

930

169 178

82

183

Number of decisions taken in 2018 according to the type of request

2 Regional Directorate for Food, Agriculture and Forestry (DRAAF); Regional Food Service (SRAL). 3 Directorate General for Customs and Indirect Taxation (DGDDI); National Directorate for Customs Intelligence and Investigations (DNRED). 4 National Brigade for Veterinary and Phytosanitary Investigation (BNEVP).

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Moreover, as part of the simplification of proce-dures for users, the project to digitise applications (D-Phy) continued and entered its second phase. This is designed to make ANSES considerably more effi-cient by saving time on data entry and the handling of documents in paper format, improving the relia-bility of administrative data collection and shorte-ning the time needed to process dossiers. Phase 1 of this project has already provided applicants with an online system for entering the uses of the products covered by the application.

Lastly, ANSES continued its extensive work in asses-sing plant protection active substances, which is illustrated by the figures in the table below. This activity concerns previously authorised substances that have to undergo an assessment for the review of their re-approval, or new substances that have to be assessed with a view to obtaining a first approval.

Number of dossiers processed, by category (2014-2018) ANSES’S WORK IN ASSESSING PLANT PROTECTION ACTIVE SUBSTANCES

2014 2015 2016 2017 2018

Dossiers submitted

– RMS5 10

(4 micro-organisms)4

(0 micro-organisms)2

(1 micro-organism)6

(2 micro-organisms)

Dossiers submitted – Co-RMS

6 7 6 0 10(0 micro-organisms)

Finalised assessment

reports – RMS

6(5 micro-organisms)

7(2 micro-organisms)

6 10 13(1 micro-organism)

Finalised assessment

reports –Co-RMS

3 5 5 12 13(2 micro-organisms)

Substance activity

indicator20 29 21 24 42

RMS: Rapporteur Member State.

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ANSES’S WORK IN THE AREA OF PLANT PROTECTION PRODUCTS, FERTILISERS AND GROWING MEDIA IN 2018

There was intense activity in the third full calendar year (January to December 2018) following the transfer to ANSES of competence for MAs and permits for plant protection products, fertilisers and growing media:

5 This concerned all types of dossiers relating to active substances: amendments, classifications, confirmatory data, MRLs, new substances, renewals, specifications, administrative amendments, etc.

348applications relating to dossiers for active substances were received 5

1 891applications relating to marketing authorisations or experimentation permits were received, of which 179 involved fertilisers and growing media, 27 adjuvants, and 1685 plant protection products. The latter included:

>> 162 dossiers regarded as “major”, because they concerned either a new MA, or a product re-examination following the re-approval of an active substance, or an extension of major uses

>> 819 dossiers for administrative applications

>> 172 applications for experimentation permits

>> 119 applications for parallel trade permits

>> 413 other applications subject to scientific assessment

More than 2 000 decisions were signed, of which 183 concerned fertilisers and growing media, 82 adjuvants and 1 819 (87% of the total) plant protection products. These included:

>> 204 decisions corresponding to dossiers regarded as “major”

>> 930 administrative decisions

>> 169 decisions relating to experimentation permits

>> 178 decisions relating to parallel trade permits

>> 338 other authorisation decisions subject to scientific assessment

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ANNUAL REPORT 2018

IN 2018, ANSES CONTINUED ITS EFFORTS TO FACILITATE THE MARKETING OF BIOCONTROL PRODUCTS

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In order to facilitate access to the market for biocontrol products, a certain amount of latitude is granted for applications concerning plant protection products meeting the criteria for biocontrol products, referred to in Article L253-6 of the French Rural and Maritime Fishing Code. In particular, these products are dealt with immediately and benefit from a lower tax rate. In accordance with the national regulatory provisions that stipulate a halving of the processing time for new authorisations, the Agency also gave priority to the assessment and examination of these dossiers.

Thus, in 2018, of the dossiers identified during submission as relating to biocontrol:

17 applications for macro-organisms (not covered by the plant protection regulations) were received;

39 applications for MAs and new uses (first MAs, MAs by mutual recognition, generic products, extensions of major use) were received;

53 decisions were taken on applications for new MAs and new uses, compared to 45 in 2017, representing a 17% increase in the number of decisions issued.

biocontrol dossiers: new MAs and new uses

5

18

59

39

3

11

45

53

2015 2016 2017 2018

NUMBER OF INCOMING/OUTGOING

60

50

40

30

20

10

0

OUTGOING BIOCONTROL DOSSIERS INCOMING BIOCONTROL DOSSIERS

Change in the scope of

biocontrol in 2017

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ANNUAL REPORT 2018

L’ANSES A POURSUIVI EN 2018 SA MOBILISATION POUR FACILITER LA MISE SUR LE MARCHÉ DES PRODUITS DE BIOCONTRÔLE

IMPROVING INFORMATION AND DIALOGUE WITH STAKEHOLDERS

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The file of information on MAs (authorised products), available as open data on the data.gouv.fr website, also evolved, offering new information requested by users. To ensure regular dialogue with all stakeholders, in 2018 ANSES formalised the platform for dialogue with stakeholders, chaired by Bernard Chevassus-au-Louis. Three plenary meetings were held in February, May and November 2018 to discuss product assessment, MA issuing and phytopharmacovigilance activities. Each one brought together some sixty participants representing all the stakeholders, and saw the development of a productive, constructive dialogue in which all parties were able to participate.

Following a proposal by the chair of the dialogue platform and in response to the wishes of certain stakeholders, a training meeting on the E-Phy tool also took place in December 2018, to

In 2018, ANSES continued its work to improve information and dialogue in its PPP/fertiliser/growing media activities. The E-Phy website, the catalogue of products and their uses, has evolved, with the inclusion of parallel trade permits and the conditions of use of these products. These permits represent nearly a third of all products placed on the market in France.

give website users an introduction to the tool or enable them to master its potential. A second meeting is already planned for spring 2019.

In order to improve the dissemination of information on MAs, and in addition to the decision register and the E-Phy website, ANSES launched the first issue of its MA bulletin in December 2018, which was posted on its website. This monthly bulletin now summarises the decisions taken concerning plant protec-tion products and adjuvants: decisions on product withdrawals, new marketing authorisations and major MA amendments (new uses granted, changes in conditions of use, withdrawals of uses, etc.). It provides easier access to the decisions taken by the Agency.

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ANSES’S WORK IN THE AREA OF BIOCIDAL ACTIVE SUBSTANCES AND PRODUCTS IN 2018

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Application type Number

First MA: initial application 23

First MA: minor/major change 57

Mutual recognition 75

Administrative applications 150

Other: R&D notifications, provisional MAs 36

Renewal dossiers 28

Total 369

There was a relative decrease in the number of applications rela-ting to biocidal products in 2018. However, it should be noted that this decrease only concerned administrative applications, while applications involving assessments remained stable, confirming the growth observed in 2017. This increase in the number of MA applications is expected to continue steadily as substances are approved at European level as part of the imple-mentation of Regulation (EU) No 528/2012 in Europe.

The activity to issue marketing authorisations increased signi-ficantly compared to 2017. In 2018, ANSES issued decisions for

571 biocidal products, including 110 relating to a first MA, major change or mutual recognition. It should be noted that a signi-ficant part of this activity concerned MA withdrawals, on the initiative of either the MA holder or ANSES.

Lastly, assessments for biocidal active substances experienced a relative decline, mainly due to the decrease in the flow of reports submitted for comments. ANSES nevertheless reviewed and commented on almost all of the reports submitted for comment, i.e. seven out of nine reports.

ANSES’S WORK IN THE AREA OF BIOCIDAL ACTIVE SUBSTANCES

2014 2015 2016 2017 2018

Finalised assessment reports (first draft Competent Authority Reports – CARs) sent to ECHA 16 5 8 1 3

Assessment reports submitted by other Member States and commented on by ANSES 13 15 33 35 7 6

Number of applications relating to biocidal products in accordance with Regulation (EU) No 528/2012 received by ANSES in 2018

Number of dossiers processed (2014-2018) as Rapporteur Member State and as a Member State involved in the European process

6 This reduced number compared to previous years was due to the fact that in 2018, Member States sent very few assessment reports to ECHA. These seven contributions from ANSES corresponded to almost all the reports open for comments.

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PHYTOPHARMACOVIGILANCE

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In 2018, ANSES continued to develop and ramp up its phytophar-macovigilance scheme, with:

the extension of its network to three new partner organisa-tions, listed in the Ministerial Order of 14 December 2018,

the investigation of reports of adverse effects,

the production and publication of summaries by active subs-tance from the data available from the partner schemes,

the initiation of new studies to consolidate the surveillance and data collection schemes that work in partnership with phytopharmacovigilance and generate new knowledge.

THE NETWORK OF PARTNERS IN PHYTOPHARMACOVIGILANCEIn 2018, three new organisations joined the phytopharmacovi-gilance network, enabling data to be collected on the impacts of plant protection products that were not or only minimally covered by the network. These are the «Toxinelle» scientific inte-rest group for monitoring mortality and morbidity of domestic animals and poisoning cases, the Indoor Air Quality Observa-tory for monitoring indoor air and dust, and the «Sol» scientific interest group for monitoring soil. These three organisations join the schemes led by the Ministries of Agriculture, Health, Ecology and Consumer Affairs that provide monitoring data on food, environmental water and drinking water, and the nine existing partner agencies: Santé publique France, the François Baclesse Centre, the Technical and Scientific Institute of Beekee-ping and Pollination (ITSAP), the National Office for Hunting and Wildlife (ONCFS), the Central Laboratory for Air Quality Moni-toring (LCSQA), as well as the approved air quality monitoring associations (AASQAs), the National Network for Monitoring and Prevention of Occupational Diseases (RNV3P), the Agricul-tural Mutual Insurance Scheme (MSA) and the Poison Control and Monitoring Centres (CAP-TVs).

Phytopharmacovigilance, created under the French Act on the future of agriculture, food and forests in October 2014, is intended to monitor and detect any adverse effects on humans, farmed animals including honeybees, cultivated plants, biodiversity, wildlife, water and soil, air quality and food, following the use of plant protection products, as well as the emergence of resistance to these products. This scheme, implemented under ANSES’s responsibility, enables the continual production of information for the benefit of risk assessment, placing products on the market, and the risk management missions performed by ANSES and the competent ministries.

COLLECTION AND INVESTIGATION OF REPORTS OF ADVERSE EFFECTS: IMPROVED TOOLS FOR COLLECTION AND MONITORINGIn order for the phytopharmacovigilance scheme to be effec-tive, appropriate tools need to be introduced for identifying all reports of adverse effects potentially related to plant protection products. Firstly, on a yearly basis, ANSES’s phytopharmacovi-gilance partners generate millions of data including reports of adverse effects or even alerts. In addition, ANSES made repor-ting forms available on its website in 2018, in particular for professionals with a reporting obligation (MA holders, manu-facturers, importers, distributors, professional users, advisers and trainers). This has extended its network’s ability to collect reports with a new tool, which then makes it possible to redirect the report, if necessary, to the organisation responsible for its analysis.

Literature monitoring also helps identify the results of scientific research that may be regarded as «real-life» reports of adverse effects.

The information collected is processed by ANSES in close colla-boration with its partners and reporters, in order to classify the reports, the nature of the observed effects, their spatio-tempo-ral magnitude, the circumstances under which they arose, their link with the incriminated plant protection products, and their potential impact on populations and their environment.

Several alerts and signals received by ANSES underwent an in-depth analysis in 2018:

Multiple poisonings of residents by metam-sodium: several operations to treat lamb’s lettuce crops with products contai-ning this active substance caused a series of clustered poisonings of local residents and walkers in Maine-et-Loire. The exceptio-nally hot, dry weather conditions in autumn 2018 favoured the volatilisation of the degradation substance of metam-sodium buried in the ground. These adverse effects corroborated the findings of an unfavourable assessment conducted as part of the planned regulatory re-examination of MAs for products containing metam-sodium.

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Prosulfocarb contamination of untreated crops: this report led to initial risk management measures in 2017, but in view of the persistence of the unexpected spread of this active subs-tance, measures to prevent this spread were stepped up in 2018. Their effectiveness will be assessed in early 2019 and, if the measures taken prove to be insufficient, the results of this assessment could lead to a reconsideration of the marketing authorisations for the products concerned.

The potential toxicity of SDHI fungicides was also the subject of a warning signal issued by a team of scientists in April 2018. On receipt of this alert, ANSES set up a group of independent experts to assess the hypotheses formulated and determine whether they constituted a health alert. On completion of this work, ANSES concluded that the information and hypotheses put forward did not provide any evidence to support a health alert for humans and the environment related to the agricultural use of these fungicides that justified amending or withdrawing the MAs of products containing them.

The other reports received in 2018 were investigated without any risk management measures being required. They are included, together with other monitoring data, in the regular reviews prepared by ANSES or its partners.

SUMMARISED REVIEWS OF KNOWLEDGE FOR THE ASSESSMENT OF PLANT PROTECTION PRODUCTSIn order to make phytopharmacovigilance data available both to the ANSES teams responsible for assessing and re-assessing MAs and to any other interested parties, ANSES regularly reviews the available phytopharmacovigilance data on the active subs-tances used in plant protection products. To this end, the Agency calls on its partners in order to obtain information from national monitoring and vigilance schemes.

The priority substances studied are those for which marketing authorisation applications or amendments are currently being examined by ANSES, including when these involve recently authorised substances. This information supplements the results of the a priori risk assessment from the dossiers submit-ted by the applicants seeking MA renewal. Special attention is also paid to substances concerned by specific uses, or by agro-nomic, health or environmental issues in France. All the data collected for a substance or product in the framework of phyto-pharmacovigilance can also be reviewed to support the analysis of a report involving an adverse effect.

These reviews, in the form of fact sheets for each active substance, are now placed online on ANSES’s website, along with an informa-tion note describing the sources and nature of the available informa-tion (https://www.anses.fr/en/content/phytopharmacovigilance-fact-sheets-more-information-plant-protection-substances).

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STUDIES TO CONSOLIDATE PARTNER SCHEMES, GENERATE NEW KNOWLEDGE, AND REVIEW REPORTS The information available through the phytopharmacovigilance scheme sometimes needs to be supplemented by strengthening the existing schemes or generating missing knowledge, for example when a new report emerges. To this end, ANSES undertakes specific studies. They must be able to respond to precise questions with a view to rapid application to the MA conditions.

For the period 2018-2020, ANSES has identified four strategic priorities for the studies:

ambient air for the general population and for specific populations;

exposure and the impact on agricultural workers;

bees and other pollinators;

biodiversity and environmental media (soil).

These priorities may be reviewed to take account of any changes in the phytopharmacovigilance scheme. ANSES also gives itself the opportunity to undertake studies in emergency situations following alerts or new evidence requiring a signal to be investigated or more knowledge to be produced.

PPV themes Studies under way (started before 2018)

Studies launched in 2018

Studies completed in 2018

Air 2

Biodiversity and environments 2 1

Resistance 1 1

Animal health (bees) 2 2 2

Human health 4 4 4

Human health (food) 1

Cross-cutting 1

Since 2015, when the phytopharmacovigilance scheme was set up, 27 studies have been conducted:

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ANNUAL REPORT 2018


THE AGENCY’S OTHER ACTIVITIES IN THE AREA OF REGULATED PRODUCTS

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Moreover, many hazard and risk assessment studies contribute to the issuing of authorisations, including:

In the context of the adoption of the Act on the restoration of biodiversity, nature and landscapes, on 18 March 2016 ANSES received a formal request to conduct an assessment of the bene-fits and risks of neonicotinoids used in agriculture, and other products and methods. Investigation of this issue was comple-ted in 2018, with a report submitted to the relevant ministries.

As part of the adoption of Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determi-nation of endocrine disrupting properties, ANSES contributed to European work on drafting the EFSA/ECHA Guidance for the identification of endocrine disruptors in the context of Regula-tions (EU) No 528/2012 and (EC) No 1107/2009 (June 2018). ANSES then contributed to case studies for assessing the feasibility of operational application of the recommendations contained in this guidance document to plant protection and biocidal active substances.

Besides assessment and placing on the market of plant protection and biocidal products, ANSES carries out specific work, whether in response to formal requests, on its own initiative or as part of European projects, with input from many other ANSES activities. For example, the Observatory on Pesticide Residues collects, organises and optimises the use of information and results from testing and measurement of pesticide residues in different environments and in products consumed by humans.

In 2018, ANSES also undertook work on:

a proposed study plan to improve knowledge on the carci-nogenic potential of glyphosate;

substances of concern in plant protection products;

strengthening the regulatory framework to protect bees and other pollinators;

assessing urease and nitrification inhibitors with regard to risks to the environment, applicators and consumers.

ANSES also issued an internal request to assess the warning signal concerning the toxicity of succinate dehydrogenase inhibitor (SDHI) fungicides and on the subject of antimicrobial resistance.

This work will be finalised and the results published in 2019.

Lastly, ANSES provided scientific and technical support to the Ministries concerned on the draft regulation establishing rules for the placing on the market of fertilisers bearing the CE mark and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009, which will soon be adopted.

French Agency for Food, Environmental and Occupational Health & Safety14 rue Pierre et Marie CurieF94701 Maisons-Alfort cedex Francewww.anses.fr

@Anses_fr

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