Biocidal Products Regulation
Sectors
Articles (97)
Article 1 — Purpose and subject matterArticle 2 — ScopeArticle 3 — DefinitionsArticle 4 — Conditions for approvalArticle 5 — Exclusion criteriaArticle 6 — Data requirements for an applicationArticle 7 — Submission and validation of applicationsArticle 8 — Evaluation of applicationsArticle 9 — Approval of an active substanceArticle 10 — Active substances which are candidates for substitutionArticle 11 — Technical guidance notesArticle 12 — Conditions for renewalArticle 13 — Submission and acceptance of applicationsArticle 14 — Evaluation of applications for renewalArticle 15 — Review of approval of an active substanceArticle 16 — Implementing measuresArticle 17 — Making available on the market and use of biocidal productsArticle 18 — Measures geared to the sustainable use of biocidal productsArticle 19 — Conditions for granting an authorisationArticle 20 — Requirements for applications for authorisationArticle 21 — Waiving of data requirementsArticle 22 — Content of authorisationArticle 23 — Comparative assessment of biocidal productsArticle 24 — Technical guidance notesArticle 25 — Eligibility for the simplified authorisation procedureArticle 26 — Applicable procedureArticle 27 — Making available on the market of biocidal products authorised in accordance with the simplified authorisation procedureArticle 28 — Amendment of Annex IArticle 29 — Submission and validation of applicationsArticle 30 — Evaluation of applicationsArticle 31 — Renewal of a national authorisationArticle 32 — Authorisation through mutual recognitionArticle 33 — Mutual recognition in sequenceArticle 34 — Mutual recognition in parallelArticle 35 — Referral of objections to the coordination groupArticle 36 — Referral of unresolved objections to the CommissionArticle 37 — Derogations from mutual recognitionArticle 38 — Opinion of the AgencyArticle 39 — Application for mutual recognition by official or scientific bodiesArticle 40 — Supplementary rules and technical guidance notesArticle 41 — Union authorisationArticle 42 — Biocidal products for which Union authorisation may be grantedArticle 43 — Submission and validation of applicationsArticle 44 — Evaluation of applicationsArticle 45 — Submission and acceptance of applicationsArticle 46 — Evaluation of applications for renewalArticle 47 — Obligation for notification of unexpected or adverse effectsArticle 48 — Cancellation or amendment of an authorisationArticle 49 — Cancellation of an authorisation at the request of the authorisation holderArticle 50 — Amendment of an authorisation at the request of the authorisation holderArticle 51 — Detailed rulesArticle 52 — Period of graceArticle 53 — Parallel tradeArticle 54 — Assessment of technical equivalenceArticle 55 — Derogation from the requirementsArticle 56 — Research and developmentArticle 57 — Exemption from registration under Regulation (EC) No 1907/2006Article 58 — Placing on the market of treated articlesArticle 59 — Protection of data held by competent authorities or the AgencyArticle 60 — Data protection periodsArticle 61 — Letter of accessArticle 62 — Data sharingArticle 63 — Compensation for data sharingArticle 64 — Use of data for subsequent applicationsArticle 65 — Compliance with requirementsArticle 66 — ConfidentialityArticle 67 — Electronic public accessArticle 68 — Record-keeping and reportingArticle 69 — Classification, packaging and labelling of biocidal productsArticle 70 — Safety data sheetsArticle 71 — Register for Biocidal ProductsArticle 72 — AdvertisingArticle 73 — Poison controlArticle 74 — Role of the AgencyArticle 75 — Biocidal Products CommitteeArticle 76 — Secretariat of the AgencyArticle 77 — AppealArticle 78 — The budget of the AgencyArticle 79 — Formats and software for submission of information to the AgencyArticle 80 — Fees and chargesArticle 81 — Competent authoritiesArticle 82 — Committee procedureArticle 83 — Exercise of the delegationArticle 84 — Urgency procedureArticle 85 — Adaptation to scientific and technical progressArticle 86 — Active substances included in Annex I to Directive 98/8/ECArticle 87 — PenaltiesArticle 88 — Safeguard clauseArticle 89 — Transitional measuresArticle 90 — Transitional measures concerning active substances evaluated under Directive 98/8/ECArticle 91 — Transitional measures concerning applications for biocidal product authorisations submitted under Directive 98/8/ECArticle 92 — Transitional measures concerning biocidal products authorised/registered under Directive 98/8/ECArticle 93 — Transitional measures concerning biocidal products not covered by the scope of Directive 98/8/ECArticle 94 — Transitional measures concerning treated articlesArticle 95 — Transitional measures concerning access to the active substance dossierArticle 96 — RepealArticle 97 — Entry into force