Sanco 10524 (14 July 2015) on Parallel trade of PPP

The current guidance document is intended to facilitate the implementation of Article 52 of Regulation (EC) 1107/2009 in a harmonised and consistent way by Member States (MS).

 

Three basic conditions must be met in order for a MS to grant a parallel trade permit:

  • The plant protection product (PPP) for which an application is submitted is authorised in the MS of origin and the reference product in the MS of introduction;

  • The product from the MS of origin and the reference product in the MS of introduction are of identical composition (see Chapter 4);

  • An application is submitted in the MS of introduction.

Cases where conditions for parallel trade are not fulfilled:

  • Importation from third countries;

  • Introduction from a MS other than that stated in the parallel trade permit;

  • Parallel trade of paralleled traded products.

Procedure

In accordance with Regulation (EC) 1107/2009, a simplified procedure for parallel trade permit is provided with  a very strict timeframe of 45 days for the examination and issuing of a decision. This period starts on the day when the application is considered as complete.

Criteria for granting parallel trade permits

  • Same Manufacturer for both the reference product and the parallel traded product; if different, information is provided from the MS of origin that this manufacturer operates as an “associated undertaking” or “under license” on behalf of the manufacturer of the reference product,

  • Same or equivalent packaging size, same material and equivalent form,

  • Same Specifications, content of a.s., safeners and synergists, and type of formulation,

  • Coformulants either identical or equivalent.

IMPORTANT!

In order to allow MS to evaluate the parallel trade permit application within the timeframe, 2 categories of coformulants were created and possible deviations determined.

Category 1: significant coformulants, essential for the functioning, the safety or stability of the PPP

Parallel traded PPP should contain the same Category 1 co-formulants (same CAS No.) and quantitative variations should only be accepted within a small margin (FAO tolerances).

Examples: adhesive (sticker), emetic, thickener, preservative, antioxidant, antifreeze, stabiliser, repellent, buffer, antifoaming agent, anti-caking agent, emulsifier, dispersing agent, propellant, wetting agent, solvent

Category 2: coformulants considered non-significant for the assessment of identity (little functional role in the PPP)

MS may exercise a greater degree of tolerance for both qualitative and quantitative changes in Category 2 co-formulants.

Examples: deodorant, dye, miscellaneous, free-flowing agent, carrier, binder

 

To be noted

  • Regulation (EC) 1107/2009 does not prohibit re-packaging of PPP. Nevertheless, this is a crucial step in the parallel trade of PPP that usually creates the most concerns for MS. In the case of deviations a decision will then be taken on a case-by-case basis.

Labelling requirements

  • The new label should contain exactly the same information as on the label of the reference product and must be in the national language(s) of the MS of introduction if required by the MS of introduction;

  • The name and address of the permit holder and the permit number should be included on the label;

  • The formulation batch number and the production date must clearly be displayed on the label;

  • The parallel trader should adhere to the requirements of the MS of introduction and the new label must be properly affixed in order to avoid that it tears off during handling and use;

  • If the product is re-packed, the name and the address of the company that is responsible for the packaging and labelling should also be included on the label.

Withdrawal or amendment of parallel trade permits

  • Parallel trade permits granted are subject to an amendment or withdrawal if the reference product has been amended or withdrawn;
    Nevertheless parallel trade permits will remain valid when the authorisation of the reference product has been withdrawn by the MS of introduction following a request from the authorisation holder;

  • On a case by case basis parallel trade permits granted are subject to withdrawal whenever the authorisation of the product of introduction has been withdrawn by the MS competent authority of origin for safety or efficacy reasons.

Renewal of parallel trade permits

  • Upon the expiry date of a parallel trade permit a new application needs to be submitted.

http://ec.europa.eu/food/plant/pesticides/guidance_documents/docs/wrkdoc18_en.pdf

 

Lynxee consulting’s team is at your disposal to prepare your application for a parallel trade permit.
Contact us! http://lynxee.consulting/en/contact/

 

Sanco 12184 (14 July 2015) on emissions of PPP from protected crops to environment

On 14 July 2015, the Standing Committee on Plants, Animals, Food and Feed agreed to postpone the application date of Guidance Document on clustering and ranking of emissions of plant protection products and transformation products of these active substances from protected crops (greenhouses and crops grown under cover) to relevant environmental compartments from (initially) 1 May to 1 December 2015 (Sanco/12184/2014 rev 5.1).

The full guidance, published in March 2014  (EFSA Journal 2014;12(3):3615), can be downloaded directly on EFSA website.

Moreover the new Greenhouse Emission Model (GEM) has been made available at www.pesticidemodels.eu.

Lynxee consulting’s team is at your disposal to conduct the risk assessments of your products intended for protected crops.

Contact us!

 

Sanco 13170 (14 July 2015) on Renewal of the Authorisation of PPP according to Article 43

This guidance document, updated on 14 July 2015, has been developed to elaborate the procedures for the renewal of authorisations of PPPs according to Article 43 of Regulation (EC) No. 1107/2009.

The procedures described only apply to renewals of authorisations based on active substances for which approval is renewed under the Regulation (EC) No. 1107/2009, and where safe uses have been demonstrated.

Lynxee consulting focuses on the key steps of the renewal of the authorisation of a PPP according to Article 43:

Steps

What to submit?

When to submit?

Notification of the application

to each MS where renewal of authorisation is seek

  • notification form

By the deadline for the submission of the supplementary dossier for the renewal of the active substance

First step application

to the zRMS and cMS

  • updated template of the notification form;

  • indication of agreement on the studies which are needed and where possible an expected timeframe,

  • indication on which parts of the risk assessment need updating (preferably agreed in pre-submission meetings with zRMS);

  • a “data matching list” regarding references relied upon (where relevant).

2 months following the publication of the EFSA conclusions

Second step application

to the zRMS and cMS

  • a copy of the authorisation;

  • any new information required as a result of amendments in data requirements, and criteria (changes to  endpoints arising from the active substance renewal);

  • evidence/justification that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted or necessary to amend the conditions of approval;

  • any information to demonstrate that the product complies with the requirements (conditions and restrictions) set out in the Regulation on the renewal of the approval of the active substance;

  • a report on the monitoring information, where the authorisation was subject to monitoring;

  • a complete updated draft Registration Report in which the changes to the risk assessment are highlighted;

  • a list of intended uses including a statement that no significant changes compared to previous authorisations (in the zone) exists.

  • a justification for each data point for which not all information is available as specified in Article 43(2) (outstanding data)

  • a comparative assessment for products containing candidates for substitution (to be assessed by each MS)

Within 3 months from the date of entry into force of the decision of renewal of the approval of the active substance.

At the same time the

application should be included into the EU PPP Application management System.

Data protection

The applicant may seek advice by the individual MS about the status of protected/non-protected studies.

The data generated because they were necessary for the renewal of the authorisation benefit from a data protection period of 30 months from the applicability of the decision of renewal of the authorisation.

New information related to active substance renewal

The applicant shall take into account the list of “old” and “new” studies and the list of critical endpoints that have been changed during the active substance renewal procedure in order to build the updated draft Registration Report of the PPP renewal.

Outstanding data at the 3 months deadline

Five circumstances can result in data being outstanding.The applicant must provide an appropriate justification for each situation where data is missing at the three months deadline.

The data directly related to a (new) endpoint as listed in EFSA conclusion and for which the time is too short to produce the requested study should be submitted as soon as possible taking into account the time necessary to conduct the studies (generally within 2 years).

Timelines

The zonal RMS should complete its assessment of the new information 6 months after receipt of the information (this period includes a 3 week commenting time for the applicant and the MSs of the relevant zone(s)). And then this allows 3 months for the other MSs to conduct comparative assessment (if necessary) and to decide on the renewal of their authorisations.

After every step in the procedure the EU PPP Application management System should be updated respectively by the applicant or by the concerned MS.

Products containing more than one active substance

For products containing two or more active substances the applicant shall apply for a renewal of authorisation after the renewal of each active substance contained in the PPP.

However, if the PPP contains two or more active substances and the approval of the second active substance expires within 12 months of the first one, zRMS and MSs should evaluate the data submitted for both active substances after the data for the second active substance are submitted.

 

http://ec.europa.eu/food/plant/pesticides/approval_active_substances/guidance_documents/docs/gd_renewal_1107-2009_rev_13.pdf

 

Lynxee consulting’s team is at your disposal to manage the renewal process of your products.
Contact us! http://lynxee.consulting/en/contact/

 

EFSA: Statement on the FERA guidance proposal (2012) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

The European Food Safety Authority (EFSA) Panel on Plant Protection Products (PPR) prepared a scientific opinion on the Food and Environment Research Agency (FERA) guidance proposal ‘Guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments’ (2012).

The potential for the strength of soil sorption of a substance to increase over time (‘aged sorption’) is one of the phenomenon considered by applicants and notifiers when developing higher-tier approaches for leaching risk assessment. However, the procedures used to derive parameters to allow the inclusion of aged sorption as a higher-tier refinement for regulatory submissions are currently very uncertain, as demonstrated by the variety of different approaches employed for different substances.

FERA draft guidance was drafted in that context, based on the FOCUS (2009) guidance.

The review of the draft guidance by the Panel revealed that the experimental and modelling approaches described are reasonable compromises between the required effort and what is desirable from a theoretical point of view. However, the Panel has concerns about the interpretation of the experiments and how the results of the experiments should be used in the leaching assessment. The Panel investigated options for improvement, but could not complete its evaluation on these two topics because underlying data to test these options were not made available to the Panel. For this reason, the Panel prepared a statement instead of a scientific opinion. Therefore, the Panel cannot recommend the use of the guidance for the time being.

The Panel recommends an update of the current FERA draft guidance document, taking into account the conclusions and recommendations provided in its statement.

The Panel noted that the draft guidance document did not systematically review uncertainties arising from the use of aged sorption data in regulatory leaching assessments. Uncertainties may result from, for example, the experimental procedure (extraction procedures), the conceptual model and the quality of the fitted parameters. It is recommended that a systematic review of uncertainties is carried out when updating the draft guidance document.

This updated guidance document could be resubmitted to the Panel, together with supporting data, so that the Panel can finalise its review.

EFSA: Scientific Opinion on the effect assessment for pesticides on sediment organisms in edge-of-field surface water

The EFSA Panel on Plant Protection Products and their Residues (PPR Panel) has published the second of three requested deliverables within  his mandate to revise the Guidance Document (GD) on Aquatic Ecotoxicology under Council Directive 91/414/EEC (SANCO/3268/2001 rev. 4 (final), 17 October 2002). Further to the publication in July 2013 of the Guidance Document on tiered risk assessment for aquatic organisms in edge-of-field surface waters (EFSA Journal 2013;11(7):3290) , this new scientific opinion deals with the effect assessment for sediment organisms (EFSA Journal 2015;13(7):4176) and in particular with:

  • the benthic ecology of edge-of-field surface water

    • physical, chemical and biological diversity of sediment habitats;

    • benthic communities (microorganisms, microphytobenthos, rooted macrophytes, meiobenthos such as nematodes and macrobenthos such as larvae of insects, macro-crustaceans…);

    • exposure routes (via contact, food).

  • the identification of standard test species and standardised test systems

    • internationally accepted protocols on a limited number of taxa (insects with Chironomus spp., crustacean with Hyalella azteca, oligochaete with Lumbriculus variegatus and rooted macrophyte with Myriophyllum spp.): development needed;

    • differences between OECD and US EPA protocols (nature of sediment, spiking procedure): need for comparative studies to identify consequences on toxicity estimates.

  • the identification of specific protection goals (SPGs)

    • ecological threshold option (ETO) considered as the best option to provide adequate protection of benthic organisms, in comparison to  ecological recovery option (ERO).

  • the proposition of trigger for sediment testing

    • (1) if more than 10 % of the radio-labelled test material found in the sediment at or 14 days after application in the standard water–sediment fate study (OECD Guideline 308), or more than 10 % of the total annual dose of the active substance in sediment at the time of maximum PECsed as assessed by FOCUS modelling;

    • and (2) if the chronic NOEC/EC10 of Daphnia or another relevant pelagic animal species is less than 0.1 mg/L, or the EC50 of the standard test alga or vascular plant is less than 0.1 mg/L.

  • the definition of regulatory acceptable concentrations (RACs)

    • RACs expressed in terms of (1) total sediment concentration (dry weight) normalised to either the OC content in the dry sediment or to standard OECD sediment with an OC content of 5 %, and of (2) the freely dissolved fraction in pore water;

    • use of the 0–1 cm sediment layer for PECsed derivation for benthic fauna and microorganisms;

    • use of the 0–5 cm sediment layer for rooted macrophytes;

    • RACs derivation based on chronic toxicity data using sediment-spiked tests and benthic organisms (NB: semi-chronic toxicity data can also be used with an appropriate additional extrapolation factor).

  • the use of  a tiered approach for the exposure assessment

    • FOCUS methodology in 4 steps;

    • proposal for the inclusion of an accumulation factor to account for the effect of multi-year applications, not considered in the current FOCUS approach;

    • need for new sediment scenarios for total content and pore water concentrations to improve FOCUS assessment.

  • the use of a tiered approach for the effect assessment

    • a screening step based on chronic toxicity data for pelagic organisms and the equilibrium partitioning (EqP) approach, with an extrapolation factor of 10 for benthic fauna to cover the possibility of exposure due to sediment ingestion;

    • a first tier based on chronic standard tests with a decision scheme to select the appropriate benthic test species;

    • a second tier based (1) on chronic standard tests on additional test species with the use of the Weight of Evidence (WoE) approach (geomean approach not advised), and (2) on the use of Species Sensitivity Distribution (SSD) approach if sufficient number of benthic species (at least 8 species of the potentially sensitive taxonomic group (most likely benthic arthropods for insecticides; rooted macrophytes for herbicides), or 8 toxicity data for at least 5 different taxonomic/feeding groups if no specific potential sensitive taxonomic identified);

    • a third tier based on micro/mesocosms studies using preferably field-collected sediment and combined exposure routes (both water and sediment spiking), monitoring of exposure concentrations, observations of long-term benthic population and community-level effects;

    • To be highlighted: no consolidated ERA scheme available at this stage; need for more research and analysis of data to identify the most relevant exposure routes, depending on aquatic vertebrate species and substances.

  • the risk characterisation for active substances of PPP and their metabolites (ratio between effects and  exposure levels)

    • RACsed expressed in terms of initial exposure concentrations vs. PECsed, max as realistic worst-case;

    • PECsed, twa only used when field exposure concentrations being sufficiently variable during a time frame smaller than the duration of the sediment-spiked toxicity test that drives the RACsed;

    • two senarios advised: one with low OC (worst-case pore water scenario) and one with high OC (worst-case total content scenario);

    • need for the development of  environmental scenarios for ponds, ditches and streams;

    • relative contribution of the older (e.g. > 1 year) and recent fractions (e.g. latest growing season) in the PECsed,tot to be considered in a higher tier.

A later PPR Panel scientific opinion will deal with possible mechanistic effect models that can be used in the aquatic risk assessment for sediment-dwelling organisms. The adoption is foreseen for end 2017.

France : Revision of E-Phy database

E-Phy database, the catalog for plant protection products, adjuvants, fertilisers and growing media, and their authorised uses in France, constitutes a reference tool that is currently outdated  in term of  interface and technology. The French Agency for Food, Environmental and Occupational Health & Safety (Anses) is working on the revision of E-Phy database in order to propose a tool with ergonomics and functionalities corresponding to current standards.

The new E-Phy database will give information on authorised products and active substances: it will aim at providing information to both professionals and general public. The characteristics and conditions of use of the products, as defined in Anses’ opinions and decisions will be shown. The site will also give more general complementary information, for example on good practice and on post-authorisation follow-up.

The new E-Phy website will be available by the end of 2015.

Attention: while waiting for the publication online of the new tool, the current website will not be updated anymore . During this period of transition, it is recommanded to consult in parallel the recent authorisation decisions directly on Anses website.

France : New responsabilities for Anses from 1 July 2015

From 1 July 2015, in accordance with French legislation for agriculture, food and forestry of 13 October 2014, Anses is in charge of granting  approvals for plant protection products and adjuvants. The Ministry of Agriculture was previously in charge of it.

The décret No.2015-791 of 30 June 2015 on the conditions for the exercise by the Agency of these new missions  specifies the technical conditions of the transfer of the approval granting from the French Minister of Agriculture to Anses Managing Director.

Indeed, since 1 july 2015, Anses Managing Director has authority for approval granting and for  trial permit approval and parallel trade. It has to be noted that the French Ministry of Agriculture keeps the responsibility for the 120-day derogations as defined  in Article 53 of Regulation (EC) No.1107/2009.

The Decree also institutes a declaratory system replacing the prior approval system for some administrative changes of authorisations, to simplify procedures that do not require any assessment by the Agency.

In addition, the decree removes the separate deadlines for the evaluation by Anses and the approval management by the Ministry of Agriculture. Now, the overall timelines given in Regulation No.1107/2009 will apply. The allocation of time between evaluation and approval management now depends on the internal organisation of the Agency.

Finally, the text sets up a shorter procedure for the evaluation and authorisation of biocontrol products.

To ensure the functional separation between scientific assessment and approval granting, two distinct and independent  departments were created. The Department for approval (DAMM) and the Department for the assessment of regulatory products (DEPR, ex-DPR).

The newly formed DAMM consists of two units:

– the Administrative Unit, unique contact point for notifiers for contractual and administrative aspects with Anses, in charge of the dossier completeness check and the processing of administrative dossiers;

– the Approval Decision Unit, in charge of the preparation, follow-up and renewal of approval decisions.

All assessment conclusions and decisions will be published in the Register of authorisations and assessment conclusions.

For transparency, Anses decided to develop guidelines to clarify the principles adopted by the DAMM for the issue of approval decisions.

The draft guidelines were submitted electronically to public consultation from 12 May 2015 to 5 June 2015. The comments received during the public consultation have not challenged the principle of these guidelines. A note summarising the comments received and those taken into account was published by Anses on 1 July 2015.

The DAMM will also contribute to the implementation of the comparative assessment of products available on the market under the new provisions of EU regulation to come into force on 1 August 2015.

Furthermore, in accordance with the law, a Committee of Approvals monitoring will also be formed in autumn 2015. This advisory structure will provide to Anses management further insight to the scientific evaluation to ensure in particular that the risk management measures imposed as part of the authorisations are practicable and effective in a real situation, given the constraints of field practices.

Note, to preserve the independence of the Agency, a Charter on relations with the stakeholders is being developed.

Finally, since 1 July 2015, ANSES is also entrusted with the implementation of a monitoring system called ‘phytopharmacovigilance’ (PPV) of the effects of these products on human health, fauna, flora and environment. This system will strengthen current arrangements for post-authorisation monitoring.

If you have questions about the new missions of ANSES, please do not hesitate to contact us: +33 9 72 50 40 29.

We are also at your disposal for all your questions about the status of Anses opinions or informal appeals not solved by DGAl on 30 June 2015.