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Biocidal Products Regulation In force since 1 September 2013

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products
32012R0528 · official text on EUR-Lex

This English text is a careful, terminology-researched translation prepared by eucite.com — not an official government translation. The German original linked above is the legally authoritative text.

Articles

Chapter I SCOPE AND DEFINITIONS

• Article 1 — Purpose and subject matter
• Article 2 — Scope
• Article 3 — Definitions

Chapter II APPROVAL OF ACTIVE SUBSTANCES

• Article 4 — Conditions for approval
• Article 5 — Exclusion criteria
• Article 6 — Data requirements for an application
• Article 7 — Submission and validation of applications
• Article 8 — Evaluation of applications
• Article 9 — Approval of an active substance
• Article 10 — Active substances which are candidates for substitution
• Article 11 — Technical guidance notes

Chapter III RENEWAL AND REVIEW OF APPROVAL OF AN ACTIVE SUBSTANCE

• Article 12 — Conditions for renewal
• Article 13 — Submission and acceptance of applications
• Article 14 — Evaluation of applications for renewal
• Article 15 — Review of approval of an active substance
• Article 16 — Implementing measures

Chapter IV GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS

• Article 17 — Making available on the market and use of biocidal products
• Article 18 — Measures geared to the sustainable use of biocidal products
• Article 19 — Conditions for granting an authorisation
• Article 20 — Requirements for applications for authorisation
• Article 21 — Waiving of data requirements
• Article 22 — Content of authorisation
• Article 23 — Comparative assessment of biocidal products
• Article 24 — Technical guidance notes

Chapter V SIMPLIFIED AUTHORISATION PROCEDURE

• Article 25 — Eligibility for the simplified authorisation procedure
• Article 26 — Applicable procedure
• Article 27 — Making available on the market of biocidal products authorised in accordance with the simplified authorisation procedure
• Article 28 — Amendment of Annex I

Chapter VI NATIONAL AUTHORISATIONS OF BIOCIDAL PRODUCTS

• Article 29 — Submission and validation of applications
• Article 30 — Evaluation of applications
• Article 31 — Renewal of a national authorisation

Chapter VII MUTUAL RECOGNITION PROCEDURES

• Article 32 — Authorisation through mutual recognition
• Article 33 — Mutual recognition in sequence
• Article 34 — Mutual recognition in parallel
• Article 35 — Referral of objections to the coordination group
• Article 36 — Referral of unresolved objections to the Commission
• Article 37 — Derogations from mutual recognition
• Article 38 — Opinion of the Agency
• Article 39 — Application for mutual recognition by official or scientific bodies
• Article 40 — Supplementary rules and technical guidance notes

Chapter VIII UNION AUTHORISATIONS OF BIOCIDAL PRODUCTS

Section 1 Granting of Union authorisations

• Article 41 — Union authorisation
• Article 42 — Biocidal products for which Union authorisation may be granted
• Article 43 — Submission and validation of applications
• Article 44 — Evaluation of applications

Section 2 Renewal of Union authorisations

• Article 45 — Submission and acceptance of applications
• Article 46 — Evaluation of applications for renewal

Chapter IX CANCELLATION, REVIEW AND AMENDMENT OF AUTHORISATIONS

• Article 47 — Obligation for notification of unexpected or adverse effects
• Article 48 — Cancellation or amendment of an authorisation
• Article 49 — Cancellation of an authorisation at the request of the authorisation holder
• Article 50 — Amendment of an authorisation at the request of the authorisation holder
• Article 51 — Detailed rules
• Article 52 — Period of grace

Chapter X PARALLEL TRADE

• Article 53 — Parallel trade

Chapter XI TECHNICAL EQUIVALENCE

• Article 54 — Assessment of technical equivalence

Chapter XII DEROGATIONS

• Article 55 — Derogation from the requirements
• Article 56 — Research and development
• Article 57 — Exemption from registration under Regulation (EC) No 1907/2006

Chapter XIII TREATED ARTICLES

• Article 58 — Placing on the market of treated articles

Chapter XIV DATA PROTECTION AND DATA-SHARING

• Article 59 — Protection of data held by competent authorities or the Agency
• Article 60 — Data protection periods
• Article 61 — Letter of access
• Article 62 — Data sharing
• Article 63 — Compensation for data sharing
• Article 64 — Use of data for subsequent applications

Chapter XV INFORMATION AND COMMUNICATION

Section 1 Monitoring and reporting

• Article 65 — Compliance with requirements
• Article 66 — Confidentiality
• Article 67 — Electronic public access
• Article 68 — Record-keeping and reporting

Section 2 Information about biocidal products

• Article 69 — Classification, packaging and labelling of biocidal products
• Article 70 — Safety data sheets
• Article 71 — Register for Biocidal Products
• Article 72 — Advertising
• Article 73 — Poison control

Chapter XVI THE AGENCY

• Article 74 — Role of the Agency
• Article 75 — Biocidal Products Committee
• Article 76 — Secretariat of the Agency
• Article 77 — Appeal
• Article 78 — The budget of the Agency
• Article 79 — Formats and software for submission of information to the Agency

Chapter XVII FINAL PROVISIONS

• Article 80 — Fees and charges
• Article 81 — Competent authorities
• Article 82 — Committee procedure
• Article 83 — Exercise of the delegation
• Article 84 — Urgency procedure
• Article 85 — Adaptation to scientific and technical progress
• Article 86 — Active substances included in Annex I to Directive 98/8/EC
• Article 87 — Penalties
• Article 88 — Safeguard clause
• Article 89 — Transitional measures
• Article 90 — Transitional measures concerning active substances evaluated under Directive 98/8/EC
• Article 91 — Transitional measures concerning applications for biocidal product authorisations submitted under Directive 98/8/EC
• Article 92 — Transitional measures concerning biocidal products authorised/registered under Directive 98/8/EC
• Article 93 — Transitional measures concerning biocidal products not covered by the scope of Directive 98/8/EC
• Article 94 — Transitional measures concerning treated articles
• Article 95 — Transitional measures concerning access to the active substance dossier
• Article 96 — Repeal
• Article 97 — Entry into force