Presentation on theme: "Evaluation of active substances under the Review programme and its impact on biocidal products authorisation process and placing on the market Dr Andy."— Presentation transcript:
Evaluation of active substances under the Review programme and its impact on biocidal products authorisation process and placing on the market Dr Andy Adams Bayer Environmental Science, Lyon, France Workshop on REACH and EU Biocides legislation, Belgrade 31st May – 1st June 2012
page 2 Title 01 May 2015 Introduction How it was supposed to happen Where are we? What has been the impact? Rodenticides Insecticides What does it mean for formulators? Summary
Presentation May 1, 2015 Slide 3 BPD Timetable (according to the text) 28/03/200430/04/200631/07/200731/10/2008 Completeness check Evaluation Comments Decision-making Annex I listing Product Registration List 1: PT14: Rodenticides PT18: Insecticides Anticipates approx. 2 years from submission to decision
Where are we? The Commission website provides a consolidated list of inclusion decisions. May 2012 summary: List 1 (2004) – PT8, 25 inclusion decisions (16 decisions to come) - PT14 13 inclusion decisions (2 decisions to come) List 2 (2006) - PT18, 15 inclusion decisions (48 decisions to come) - PT19, 4 inclusion decisions (12 decisions to come) List 3 (2007) - PT12, 1 inclusion decision (42 decisions to come) (18 PTs with no inclusion decisions yet) Total: 58 inclusions, approx. 650 decisions remaining. page 4 Title 01 May 2015
What has been the impact on rodenticides? Most of the anti-vitamin K (AVK), anti-coagulant rodenticides were defended under BPD Cholecalciferol was identified but not notified, diphacinone was notified but not defended. (Under 91/414, for plant protection purposes, the only AVKs that remain approved are bromadiolone, warfarin and difenacoum.) So, the substances remain, but restrictions on their use are significantly greater than before through the introduction of risk mitigation measures as conditions for product authorisation. The issues have been related to different timings for the substances, national procedures not compatible with genuine harmonisation. Plus, inclusion is for 5 years, only, and then will come « comparative assessment ». page 5 Title 01 May 2015
Rodenticides included in Annex I CategorySubstanceDate of inclusion into Annex IExpiry date inclusion into Annex I Acute poisonAlphachloralose1 July June 2021 GasCarbon dioxide1 November October 2019 Aluminium phosphide releasing phosphine 1 September August 2021 First generation anticoagulants Coumatetralyl1 July June 2016 Chlorophacinone1 July June 2016 Warfarin1 February January 2017 Warfarin sodium1 February January 2017 Second generation anticoagulants Difethialone1 November October 2014 Difenacoum1 April March 2015 Bromadiolone1 July June 2016 Flocoumafen1 October September 2016 Brodifacoum1 February July 2017 All the anticoagulants (first and second generation) only included in Annex I for 5 years
Product authorisation and mutual recognition One of the great hopes for the BPD was that mutual recognition would work well to reduce administrative load and promote harmonisation, thereby fostering free-trade. Unfortunately, and perhaps, understandably, Member States are not keen to give up their national practises and sovereign responsibilities. An additional factor comes with the post-Annex I procedure where product dossiers are compiled by formulators who rely on a letter of access from the active substance manufacturer who secured the Annex I inclusion. A formulator in Italy may only operate in the Italian market, while another in France may operate in Spain and Belgium, for example. But both formulate essentially the same product (a wax block with x% of rodenticide A)
Post-Annex I « Gentlemen’s agreement » Annex I inclusion. Submission deadline 10 yr data protection starts Standing Committee Vote Publication Dossier preparation (submission?) Completeness check Review 9 months Mutual recognition 24 months 3m LoA 12 months ??? Compliance deadline is the limit for re-reg (4y after entry into force) Sell out …… No LoA 2 months to apply; 4 months for MS to evaluate; 3 month « buffer »
Problems with compliance deadline The compliance deadline is written into national law with the transcription of the BPD, so all products linked to the included ai/PT must be approved by then. Respecting timelines has not been a feature of the review process. Problems with the first actives, dichlofluanid, difethialone … EMS took too long, no time for MR!!! What were the implications in practise?? ………………..
Real impacts!! The German case: UK was late completing evaluation of dichlofluanid products, no time for Germany to grant MR before the deadline, companies were forced to withdraw products from the market because there was no pre-existing authorisation. This meant large costs (withdrawal, destruction of stocks), cost jobs and led to legal cases for companies who were trying to comply and products that were being defended to meet the gold standard of the BPD!!!! In other MS, the authorities found ways to extend existing authorisations until the mutual recognition procedure was completed.
Real impacts Numerous implications for industry: time to adapt to risk mitigation measures, new labels and use conditions etc. seasonal supply to outlets, sell out, logistics of manufacturing timing versus decision on authorisation conditions… These issues hit those who are complying with the standards set by the BPD and introduce more cost while their competitors remain on the market with products that have not been evaluated yet due to delays in the review. Big incentive to slow things down and stay on the market. Totally contrary to the aims of the legislation.
Administering Mutual Recognition In principle, a product dossier is submitted to an Evaluating Member State (EMS) EMS conducts evaluation and grants authorisation Applicant makes formal MR application to other MS Other MS base their examination on summary dossier and the authorisation conditions from the EMS Other MS recognise the approval conditions as determined by EMS according to uniform principles
A « simple » case Active substance A is defended by one company which is also the only formulator in EU. They provide formulated product to third parties to place on local markets under own brands. A is formulated into 5 products and these 5 dossiers are reviewed by one Evaluating Member State (EMS). Upon authorisation in the EMS, applications for mutual recognition are made to 15 other MS for the 5 products, with the additional notification of specific marketing companies in those countries. Net result, 5 evaluations (one for each product), 80 authorisations (16 countries, 5 products each) plus administrative marketing authorisations (no evaluation needed).
A less simple case Active substance A is defended by a task force of 3 companies. Each company formulates its own 5 products, submits to a different Evaluating Member State, and applies for mutual recognition in 10 countries. Each company also provides Letter of Access to 2 local formulators in 15 countries. Each local formulator manufactures 5 products that are essentially the same as above, and submits 5 dossiers to their local Competent Authority
The risk of duplication ….. In this case, potentially: Manufacturers: 3 x 5 evaluations, with 3 EMS …….. then mutual recognition.. Formulators: 2 x 15 x 5 evaluations with 15 EMS Net result: 165 evaluations, involving 18 MS (and then mutual recognition??) But, we are still in a scenario where 5 evaluations from 1 MS should suffice!!! Unnecessary work, and unnecessary costs!!
page 16 Title 01 May 2015 The risk of duplication The real case of difenacoum …. Several companies can grant access to a. s. dossier Some may defend end use products themselves Or supply a.s. to formulators who defend their own products Net result: less than 10 formulation types with slight variations (block, pellet, paste, grain …) at the same concentration of active substance. 10 evaluations would be plenty. But, more than 100 dossiers submitted!! Already R4BP shows 4000 MR applications!!!!!!! UNSUSTAINABLE!!
Risk Mitigation Measures Where the fun really starts …. Rodenticides are a particulary difficult group of substances for all stakeholders because, by definition, they are highly toxic to mammals, plus the concerns about secondary poisoning risks to birds of prey. At the same time, it is widely recognised that these products provide important benefits by controlling pests that pose a serious risk to the human population, through potential disease transmission, damaging the fabric of buildings, consuming stored goods etc etc … The authorities have a duty to protect the public and the environment and how they achieve this may vary from country to country. page 17 Title 01 May 2015
Harmonised risk mitigation measures – at the active substance level (1) In the Annex I inclusions for the anticoagulants it states that: All packaging of anticoagulant rodenticides is required to show safety precautions for the protection of humans, animals or the environment in the form of standard phrases. Ready-to-use products shall not contain more than X% w/w of the active substance, or products which contain more than X mg/kg of the active substance shall only be placed on the market for use by professionals trained to use them. Products shall contain an aversive agent and where appropriate, a dye. Products shall not be used as a tracking powder. [Doesn’t apply to the first generation anticoagulants.] In addition, it says…
Harmonised risk mitigation measures – at the active substance level (2) Primary as well as secondary exposure of humans, non- target animals and the environment are minimised, by considering and applying all appropriate and available risk mitigation measures. These include, amongst others, the category of user and the restriction to professional only, area of use, the formulation, setting an upper limit to package size, specific product design and laying down obligations to use tamper resistant and secure bait boxes and codes of good practice. These measures are deferred to the product authorisation stage and Member State level.
Risk Mitigation Measures Considering mutual recognition in our two cases of « simple » and « less simple » If one EMS grants an authorisation with specific risk mitigation measures, these may be adopted directly, or amended by other MS (additional procedure for change in user category). If 18 MS review the same product and apply their own risk mitigation measures, and then those measures are considered by other MS via mutual recognition ……. The net result will be that each MS will still apply the risk mitigation measures that it considers appropriate to each specific product! (In fact, one could argue that the evaluation is unnecessary since the products are so well known and MS have already decided what retrictions they will apply!!) page 20 Title 01 May 2015
What it means in practise Enormous duplication of effort when we are already way behind in time and can least afford to waste our resources. Those who worked hardest to comply were hit with restricted uses while their competitors remained on the market with their « old » labels (brodifacoum inclusion is more than 2 years after difethialone) Those who came first were investing enormous time and resources in coping with being the guinea pigs and fire-fighting the issues with the compliance deadline Every incentive to delay the process, not to expeditie it!! page 21 Title 01 May 2015
Comparative assessment The exclusion criteria included in the new Regulation were not part of the BPD, but aspects of hazardous properties meant that substances could be identified as candidates for substitution – the second gen AVKs meet the criteria for « PBT » (Persistent, Bioaccumulating and Toxic). Comparative assessment occurs at the product re-authorisation stage following active substance renewal. How will it work????? 2 nd gen AVKs are included for 5 years and renewal dossiers need to be submitted 550 days (18 months ) before expiry ……… ie 3.5 years after inclusion. Since product authorisations are arriving more than 2 years after inclusion, rodenticide manufacturers are in almost constant action to defend actives and products. page 22 Title 01 May 2015
Difethialone – timeline in reality SubstanceProduct dossier submission Date of 1 st authorisation Date of mutual recognitions Process finished Difethialone1 November February August November 2011 SubstanceProduct dossier submission Date of 1 st authorisation Date of mutual recognitions Process finished Difethialone1 November 2009 UK - 20 and 27 April 2011 NLD – 11 September 2011 ????? Theoretical Reality By the 1st November 2011 product authorisations (via mutual recognition) in Netherlands, Denmark, Germany, Slovakia and Switzerland
Difethialone status – 29 March 2012 Discussion ongoing Authorisation granted Dossier submitted UK IEIE NO SWFI PL SK CZ AU DE DK NL BE FR IT ES SW I PT LX GR
Difethialone authorisations – Indoor use only Indoor use for consumer & professional Indoor use for consumer & in and around buildings for prof. Indoor use prof only In and around buildings for professional No clarified position Paste – in and around Grain - indoors
Difethialone – no amateur use No amateur use EU notification sent to the Commission for restriction to professional Application for consumer uses withdrawn Spain & Sweden – trained professionals. Denmark – trained professionals for use against rats. Germany & Finland - professional
Difethialone – rats and/or mice Use against rats and mice for both professional & consumer Use against mice for amateur. Rats and mice professional. No clarified position
Harmonised risk mitigation measures – at the product level What the European Commission want to do now is harmonise these deferred risk mitigation measures. In December 2011 they presented two papers with a focus on risk mitigation. One looked at human health and the second at the environment. These papers were discussed again in a second meeting during w/c 27 th February The industry (Cefic, CEPA, BPCA, RRAC etc) had all (or are in the process of) written papers addressing the suggestions in these papers. What did these two papers say… ??
Harmonised risk mitigation measures – human health The human health paper proposes the following options for ALL anticoagulants: Option A – Restrict all use to professionals only Option B – Non professional baits to be supplied and used in proprietary (non- refillable) tamper-resistant bait stations. Option C - Non professional baits to be used in refillable tamper-resistant bait stations and supplied as inner packs or units containing at most enough for one bait point (either rat or mouse). Option D - Non professional baits to be used in refillable tamper-resistant bait stations and supplied loose in refill packs. Option E - Non professional baits to be used in covered bait points, with bait to be supplied as inner packs or units, each containing at most enough bait for one bait point (either rat or mouse).
Proposals The paper concludes that consumers should be allowed to control small rodent infestations but the mainstay of rodent (particularly rat) control should be professional. For non-professional use against mice the proposal is for option E (covered baits) For non-professional use against rats the proposal is for option C (bait stations). Maximum pack size for consumers of 1.5 kg.
Harmonised risk mitigation measures – Environmental Options for the second generation anticoagulants (SGARs), only. Proposal 1 – Restrict use of all SGARs to indoors only Proposal 2 – Restrict use of SGARs to in and around buildings 'In and around buildings' shall be understood as the building itself, and the area around the building that needs to be treated in order to deal with the infestation of the building. This would cover uses in sewer system or ships but not in waste dumps or open areas such as farmlands, parks or golf courses. Would affect bromodiolone and difenacoum where the inclusion Directive allows use ‘in and around’ buildings and open spaces’. Proposal 3 – Maintain the status quo of certain Member States Proposal 4 – Professional use only No proposed conclusions in the environmental paper.
Harmonised risk mitigation measures – What does this mean? The human health paper proposes a pragmatic approach whereby homeowners still have access to products, notably for mouse control. Rat control may often be best left to a professional. The environmental paper could have a serious impact on how professionals attempt to control rodents e.g. no use of second generation anticoagulants in open areas such as parks, farmland etc. The environmental paper proposes that the second generation anticoagulants should only be used by professionals (as in USA). This could present problems in areas where mice are resistant to the first generation rodenticides.
National Practise Harmonisation is a nice objective, but a little utopic for the EU Many MS have existing, or new « guidance » or « rules » to address risks from rodenticides Germany proposes to prevent amateur uses of AVKs (except voles?!!) Denmark has a list of actives to be selected in order (upon what basis?) Warfarin, alphacloralose, chloraphacinone, coumatetralyl, difenacoum, bromadiolone … UK is re-examining its previous position of only allowing outdoor use of bromadiolone and difenacoum due to more and more cases of resistance (especially bromadiolone)
Summary comments - rodenticides A much greater emphasis on safety which may be over-cautious given that most instances of poisoning are through deliberate mis-use. Restricting products to professional use, only, may result in infestations being left untreated (until the situation is worse) to avoid the expense Restricting products to use in bait stations will certainly reduce efficacy which will mean either more baiting points or longer times to establish control, or both. Professional rodent control is much more than simply placing baits according to the label, so good practise and responsible use must be promoted too. Comparative assessment and BPR timings mean that rodenticides will be under almost constant review.
What has been the impact on insecticides? Originally, just over 100 substances were notified for PT18, but in the end only half these were supported by dossiers when it came to the submission deadline in Insecticides that have gone: chlorpyrifos, malathion, temephos, fenitrothion, boric acid, diazinon, methomyl, phoxim, pirimiphos methyl, bioresmethrin, beta-cyfluthrin, fenoxycarb, s-hydroprene, several essential oils, fatty acids, hydramethylnon, propoxur, dichlorvos ….. plus non-inclusion proposal for bifenthrin page 35 Title 01 May 2015
Why were so many lost? Costs to update dossier Costs to compile dossiers Submission fees Consolidation in the industry (mergers, acquisitions) If the insecticide was not defended under 91/414, the data requirements to upgrade the information package were expensive. Organophosphates were already under scrutiny for human health reasons so might not have passed the risk assessments ………. Limited R and D budgets page 36 Title 01 May 2015
Use restrictions Passing the environmental risk assessment is not easy and the emission scenarios for PT18 include very conservative assumptions. Insecticides have secured Annex I inclusion, but we anticipate that their use patterns will be much more limited in future (eg. max. dose rates, number of applications per year, crack and crevice versus broadcast surface spray treatment). Generating higher tier studies to mitigate the risk is often expensive and may not be economically justified. page 37 Title 01 May 2015
page 38 Title 01 May 2015 Formulators How it was supposed to happen Where are we? What has been the impact? Rodenticides Insecticides What does it mean for formulators? Summary
What does it mean for formulators? Reduced choice of actives. Currently, any supplier of a supported active can supply to formulators but from Sept 1st 2013 only sources from the approved list (ie those with a full dossier, or access to the necessary information) will be able to supply the European biocides market. As actives are voted onto Annex I, the (re-)autorisation of those biocidal products by formulators will require a letter of access from an approved source so addressing this issue of supply is a critical step. The 2+ years between decision and inclusion is meant to provide formulators with time to establish supply agreements, develop dossiers for their product page 39 Title 01 May 2015
Timing Currently, 15 insecticides are voted onto Annex I, with 40 to go ….. And for some of these, the inclusion decision is unlikely in the next 2 years. In mixtures, such as aerosols with a photolabile ‘knockdown’ active plus a photostable ‘kill’ active, the product re-approval is triggered by the inclusion of the last active. PT18 Product authorisation will be spread over at least 6 and probably 10 years. Significant risk of distortion in the market, amounting to inadvertant unfair competition. page 40 Title 01 May 2015
Summary and conclusions Rodenticides will be under almost constant review due to 5 year inclusions, the phasing of inclusion decisions and comparative assessment. Restrictions on use to mitigate risk may compromise efficacy and must be linked with an even greater emphasis on responsible use by professionals Insecticides will see restricted uses on some products, long before competitors due to the phasing of inclusion decisions, primarily due to the conservative nature on environmental risk assessments. Since the BPD entered into force, 2 rodenticides and more than 50 insecticides have been withdrawn. Just 2 new insecticides (indoxacarb, metofluthrin) have been introduced. Reducing risk will not happen thanks to new chemistry – it requires better use of what exists! page 41 Title 01 May 2015