The Growing Impact of EU Legislation Dave Holah, Regulatory Affairs Bayer CropScience

Do you remember 6th June 1975? Did you vote YES? 1975- did you vote yes to stay in the EEC? hands up So those of you that did, including me - said yes to what I’m talking about next.

Content Key differences between Directive 91/414 and 1107/2009 Zonal Evaluation and Mutual Recognition Hazard Cut-Off Criteria Endocrine Disruption Comparative Assessment Recent regulatory changes from CRD to our benefit

Regulation 1107/2009 Regulation, not a Directive, therefore directly applicable from 14th June 2011. Approval for the active substance for 10 years . Key differences between Directive 91/414 and 1107/2009 Hazard-based cut-off criteria. Comparative Assessment & Substitution. Zonal Evaluations & Mutual Recognition. Loss of Provisional Authorisations. 7 years for candidates for substitution; 15 years for low risk AS; to be identified by Commission Directive 91/414 saw the loss of over 600 active substances.

Working under Regulation (EC) No. 1107/2009 Key features Evaluation of Active Substance (AS) dossier by one Member State (MS), followed by peer review of this evaluation by other authorities ahead of EU approval . Many guidance documents ( procedures) are being updated. No product registrations possible until active approved at EU level. Product registrations can then follow at a MS (country) level = Zonal Evaluation and Mutual Recognition Core set of data requirements and standard procedures for the evaluation process. Remember that Under 91/414 all the evaluation was according to ‘Risk Assessment’ principles – Experience showed this is a very robust regulatory process

Zonal Evaluation and Mutual Recognition Product evaluation EU split into 3 zones (‘political’ not ‘climatic’). One MS in each zone will evaluate the Product dossier on behalf of other countries in that zone. Other interested counties have 120 days to mutually recognise that evaluation and grant a registration There is one ‘zone’ for Seed Treatments, Protected Crops and Post-Harvest products Regulation 1107 has introduced Zonal Evaluations and Mutual Recognition for Product Dossiers. Early problems include MSs maintaining former specific requirements; very large Biological Dossiers and a lack of trust between MS Evaluators . Increasing delays in getting new product registrations. It was supposed to ease work load

Challenges – Hazard Cut-Off Criteria 1107 Introduced ‘Hazard Cut-Off Criteria’ for some key parts of the active substance assessment viz. Toxicology and Environmental Fate These criteria override ‘Risk Assessment’ considerations If a substance ‘fails’ on any of these it will most likely not be registered in future. There is now a 4-Layer process to Plant Protection Product (PPP) authorisation under 1107. This will impact on any new substance submitted in EU since 2010, and will be used to review all existing ASs when they come up for renewal (many during period 2014 – 2019)

A 4-Layer process to PPP authorisation under 1107 PPP CA&S PPP Risk Assessment AS Risk assessment AS Hazard Cut-Off Criteria 4. Products containing ‘candidate for substitution’ (AS) will be subject to comparative assessment and their uses may be subject to substitution 3. All products containing AS passing the risk criteria are evaluated against risk criteria themselves 2. Active substances passing the cut-off criteria are evaluated against risk criteria 1. Active substances (AS) evaluated against hazard cut-off criteria

Endocrine Disruption Legislation Endocrine Active Substances are widely present in the environment; only Endocrine Disruptors are of issue. Definition to be developed; draft due by Commission by 14/12/13 delayed. New studies will be needed Some studies that are in the regular pesticide data package have shown some indication of ED effect –covered in the existing risk assessments. Further evaluation may be needed to see if the effect can be considered adverse at the concentrations predicted in the environment. Natural examples are Milk, Coffee, Vitamin D, Soyabeans, etc Once definition in place; studies need to be conducted and evaluated - so the actual impact some way off yet

Endocrine Disruption Legislation What will be covered by the ED legislation? Pesticides Biocides General chemicals Cosmetics (possibly) Public consultation closed 16th January 2015 No outcome expected before 2017 Remember the legislation in not specific to Pesticides

Overall Results of the Public consultation Looking at the on-line survey Looking at individual comments Pre-written responses dominate, shows the strong lobbying pressures from the NGO’s but all plagiarism of set responses, even submitted responses on behalf of a individuals. Focus on the genuine individual responses – most in English Looking at the NGO response “Pre-written answers”

Comparative Assessment and Substitution Certain active substances still trigger hazard-based criteria and are identified as Candidates for Substitution The list of 77 actives was published by the Commission on 27 January 2015. Regulators will have to consider whether substances on this list may be Substituted by other products or practices taking the following into account; Availability of alternatives, including minor uses Resistance/chemical diversity. Economics. Practicality. Hazard based Criteria to be considered for a cfs include potential of persistency/accumulation in the environment, classification (toxicity, reproduction , carcinogenic potential), In practice CRD do not see Substitution being used often in the UK

Comparative Assessment and Substitution It is NOT a list of banned substances, nor a ranking of active substances. The listing does not question the safety, it only means that a Comparative Assessment will need to be conducted. All active substances featuring on the list will still be available on the market and are deemed safe, but could be substituted in time when a viable alternative is made available. Approval periods for CfS are limited to a maximum of 7 years. However, current approval periods will not be affected. . All approved active substances in the EU have already passed through the most stringent pesticide regulatory system in the world. 5 years to acquire experience for new products Applies to all relevant applications made after 1 August 2015 so we are now gaining experience on addressing this

Hand harvesting When a product is registered we have to take into account the safety of workers. This applies to spray operatives but also includes any worker entering the crop. These could be agronomists, hand weeding or hand harvesting . Label restrictions were the only mitigation. Other specific restrictions: Use only on carrot crops that will be mechanically harvested. Other specific restrictions: Use only on shallot crops that will be mechanically harvested, treated crops must not be hand harvested.

CRD Update – Gloves can be considered in the risk assessment! HDC working with CRD - Collected evidence that supports the argument that gloves should be considered as a mitigating factor for workers when entering a crop post-application of a plant protection product. The relevant condition(s) of authorisation will appear on the Notice of Authorisation (including EAMUs) and the product label and should give growers flexibility allowing the option for workers to enter the crop if and when appropriate gloves are worn. This a fine example of collaboration between grower organisations and the regulator http://horticulture.ahdb.org.uk/gloves

Aquatic Buffer Zones Historically CRD only allowed a 5m aquatic buffer zone for arable crops. Other MS allow greater than 5m buffer zones and took this into account in their specific risk assessments. CRD have reviewed their position: To avoid UK growers’ being denied access to products that are available to their counterparts elsewhere. Harmonisation of risk mitigation measures. Two supplementary schemes introduced: a) Interim. b) Use of Drift Reduction Technology (DRT). This is a positive move as there are examples of products that could not be regiostered in the UK under the old rules ie Maister

Buffer Zone changes - Interim Scheme ie Maister 11m Products with buffer zone distances of 6-20m cannot have their aquatic buffer zone reduced. The distances are set for each crop, so a product can have more than one buffer zone distance. Graphics - (http://assets.fwi.co.uk/)

Buffer Zone changes - DRT The three-star DRT option requires nozzles to be used at all times up to 30m from watercourses. Permitted distances are fixed at 6m, 12m and 18m. Buffer zones will be fixed for each crop, regardless of the size of the watercourse or body and application rate used, and no further reduction will be possible. Effectiveness using the 3 star DRT may be reduced. Graphics - (http://assets.fwi.co.uk/)

Thank you! Any Questions?