www.vivotecnia.com INNOVATIVE SOLUTIONS POWERING YOUR SAFETY SUCCESS
www.onlycorechem.com 2 www.vivotecnia.com APPLYING FOR BIOCIDAL PRODUCTS AUTHORISATION Strategies to get access to the EU market
GENERAL OVERVIEW Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products Biocidal products are necessary for the control of organisms that are harmful to human or animal health and for the control of organisms that cause damage to natural or manufactured materials Examples include Disinfectants, Wood Preservatives, Insecticides and other Pest Control products In Annex V the biocidal products are classified into 22 biocidal Product-Types (PTs), grouped in four main areas, examples include Disinfectants, Wood Preservatives, Insecticides and other Pest Control Biocidal products can neither be made available on the market nor used unless authorised Applies since 1 September 2013 but with Transitional Period for certain provisions ECHA coordinates all processes under the BPR 3
4 GENERAL OVERVIEW Who is affected by the BPR manufacturer of active substances or biocidal products importer of active substances or biocidal products distributor of active substances or biocidal products producer of articles treated with biocides
5 TRANSITIONAL PERIOD If the active substance is still undergoing review for the Product Type, then products can be brought to the market without needing to be Authorised under the BPR (national member states rules apply) Once the review of all the Actives in the formulation is completed an Authorisation for the product will be necessary otherwise it needs to be removed from the market within 6 months Necessary to keep track of Active Substance status because companies have less than 2 years from the publication date of Commission Implementing Regulation regarding approval to get an authorisation for the biocidal product
6 REVIEW PROGRAM Active substances status 237 already approved 32 not approved 469 under review
AUTHORISATION OF BIOCIDAL PRODUCTS Ca. 365 days Ca. 120 days Ca. 1,5 years Ca. 90 days National Authorisation: for a product to be placed only on a single market Mutual Recognition: if a company wishes to place the product on the market in several countries Union Authorisation: new alternative for companies that wish to apply for an EU-wide authorisation in one go From 1 September 2013 for product-types 1, 3, 4, 5, 18 and 19 From 1 January 2017 for product-types 2, 6 and 13 From 1 January 2020 onwards to the remaining product-types 7, 8, 9, 10, 11, 12, 16 and 22 Simplified Authorisation: for products which meet certain criteria specified in the regulation, e.g. do not contain any substances of concern (Listed in Annex I) 7
8 AUTHORISATION OF BIOCIDAL PRODUCTS Ca. 60 days Same Biocidal Products Authorisation: It is possible to apply for an authorisation for a single product (the same product ), which is identical to another authorised biocidal product (the reference product ), or for which an application for such authorisation has been submitted (the prospective reference product ) Mutual recognition and Same Biocidal Product are two different concepts. To apply for Same Biocidal Product, the product should be identical to the related reference product. The same biocidal product can be authorised only in the same market area as the related reference product, while in mutual recognition the market area is different. Same biocidal product application is meant to be the same product in the SAME member state, a mutual recognition is meant to be the same product in a DIFFERENT member state.
9 AUTHORISATION OF BIOCIDAL PRODUCTS Product Family: group of biocidal products that are used for similar purposes and contain active substances with same specifications with specified variations in the composition of the products to ensure that the level of risk is not increased or the efficacy of the product is not reduced For Product Families work in a Consortia may be a cost-effective option
INFORMATION REQUIREMENTS FOR DOSSIERS National and Union Authorisation: Annex III Applicant Identity of the Biocidal Product Physical, Chemical and Technical Properties Physical Hazards and respective Characteristics Methods of Detection and Identification Effectiveness against target organisms Intended Use and Exposure Toxicological profile for Humans and Animals Ecotoxicological studies Environmental fate and behaviour Measures to protect, humans, animals and environment Classification, labelling and packaging Evaluation and Summary (draft risk assessment) Annex II Letter(s) of Access for Active Substance(s) Decision on Technical Equivalence 10
STRATEGIES FOR COST REDUCTION Annex IV rules for adaptation of data requirements: Testing does not appear scientifically necessary Use of existing data Weight of evidence (Q)SARs In vitro methods Grouping of substances and read-accross approach Testing is technically not possible Column 3 Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates 11
12 INFORMATION REQUIREMENTS FOR DOSSIERS Mutual Recognition: IUCLID dossier is not required Nevertheless, a IUCLID dossier must be submitted with the initial NA application to the reference MS SPC in country official language Letter of access to the biocidal product and/or active substance dossier The application for MRP/MRS should be submitted through R4BP 3 Following confirmation that the submission has passed the initial checks by ECHA, the application will be forwarded to the relevant MSCA for validation and evaluation Good option for a Distributor
13 INFORMATION REQUIREMENTS FOR DOSSIERS Same Biocidal Product: IUCLID dossier is not required SPC in country official language Letter of access Decision on Technical Equivalence ECHA supporting document Application submitted through R4BP 3 Following confirmation that the submission has passed the initial checks by ECHA, the application will be forwarded to the relevant MSCA for validation and evaluation
14 INFORMATION REQUIREMENTS FOR DOSSIERS Simplified Authorisation: A IUCLID dossier (.i6z format) may be required Efficacy Data SPC in country official language Any other relevant information in support of the conclusion that the biocidal product meets the conditions laid down in Article 25 all the active substances contained in the biocidal product appear in Annex I and satisfy any restriction specified in that Annex the biocidal product does not contain any substance of concern the biocidal product does not contain any nanomaterials; the biocidal product is sufficiently effective; of concern the handling of the biocidal product and its intended use do not require personal protective equipment
15 STEPS TO OBTAIN AUTHORISATION OF BIOCIDAL PRODUCTS AT NATIONAL LEVEL Efficacy Testing Obtain Letter(s) of Access (LoA) from approved supplier(s) for respective PTs including Technical Equivalence for approved substances Data Gap Analysis Pre-submission meeting with Competent Authority Laboratory testing on Biocidal Product (contact ECHA before testing involving vertebrates) Risk Assessment IUCLID dossier, SPC and submit in R4BP Follow-up the process in R4BP providing additional information requested by the Competent Authority National & Union Authorisation
16 IT-TOOLS Active Substance Dossiers Biocidal Products Dossiers (National and Union Authorisation) Technical Equivalence Dossiers Chemical Similarity Dossiers Article 95 Dossiers R4BP: submission of dossiers and communication with Authorities SPC (Summary of Product Characteristics) editor
FEES Fees payable to EU Authorities: Union Authorisation 80000 plus Member State fee (renewal 5000 ) National Authorisation depends on EU Member State, from 3000 to 100000 Mutual Recognition 700 plus Member State fee Same Biocidal Product depends on EU Member State, from 100 to 3500 Simplified Authorisation depends on EU Member State, from 1300 to 10000 COMMISSION IMPLEMENTING REGULATION (EU) No 564/2013 Reduction not applicable for Member State fees 17
18 ADVICE Check ECHA website regularly to keep up-to-date on Active Substance approvals Start immediately as soon as decision on approval of the active substance is published Decide on the most cost-effective type of application Run 1st Efficacy test Contact AS supplier on Article 95 to negotiate and obtain LoA Check what information is included before obtaining LoA
VIVOTECNIA RESEARCH GLP certified CRO based in Madrid Testing for Chemicals REACH, CLP, Agrochemicals and Cosmetics Delivering highest quality standards in short times and at competitive prices Carlos Miguel Fazendeiro Business Developer www.vivotecnia.com linkedin.com/company/vivotecnia Mobile: +351 962 599 094 facebook.com/vivotecnia Email: fazendeiro@vivotecnia.com 19
VIVOTECNIA RESEARCH Acute oral toxicity: OECD 420, 423 425 Acute dermal / ocular toxicity: OECD 402, 404, 405 In vitro skin irritation / corrosion: OECD 431, 439 In vitro eye irritation / corrosion: OECD 491 Skin sensitization: OECD 442B Acute inhalation toxicity: OECD 403, 436 Dose Range Finding (DRF) studies Oral repeated dose toxicity: OECD 407, 408, 409, 452 Topical repeated dose toxicity: OECD 410, 411 Inhalation repeated dose toxicity: OECD 412, 413 Carcinogenesis: OECD 451, 453 Reprotoxicity: OECD 414, 415, 421, 422, 443 Genotoxicity: OECD 471 20
ONLYCORECHEM GLOBAL SOLUTIONS FOR THE CHEMICAL INDUSTRY Multidisciplinary team with over 10 years of experience. Languages include English, Portuguese and Spanish. Consultancy, Auditing, Training on Chemicals Legislation REACH and BPR Only Representative Services Conferences, Congresses, Exhibitions Recruitment and Executive Search Career Management High quality cost-effective solutions Carlos Miguel Fazendeiro Managing Director onlycorechem.com linkedin.com/company/onlycorechem Mobile: +351 963 705 402 facebook.com/onlycorechem Email: carlos@onlycorechem.com www.onlycorechem.com Our Headquarters is located in the beautiful city of Lisbon in Portugal with team members located in the EU and Worldwide. 21