Lexparency.org
Deutsch
Español
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
(Text with EEA relevance)- Recitals
CHAPTER I — SCOPE AND 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
- 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
- CHAPTER VI — NATIONAL AUTHORISATIONS OF BIOCIDAL PRODUCTS
- 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
- 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
- CHAPTER XI — TECHNICAL EQUIVALENCE
- CHAPTER XII — DEROGATIONS
- CHAPTER XIII — TREATED ARTICLES
- CHAPTER XIV — DATA PROTECTION AND DATA-SHARING
- CHAPTER XV — INFORMATION AND COMMUNICATION
- CHAPTER XVI — 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
- Final
- ANNEX I
- ANNEX II — INFORMATION REQUIREMENTS FOR ACTIVE SUBSTANCES
- ANNEX III — INFORMATION REQUIREMENTS FOR BIOCIDAL PRODUCTS
- ANNEX IV — GENERAL RULES FOR THE ADAPTATION OF THE DATA REQUIREMENTS
- ANNEX V — BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED TO IN ARTICLE 2(1)
- ANNEX VI — COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS
- ANNEX VII