Chemicals legislation is quite a vivid regulatory arena. As is the case in the science of Chemistry itself there is also no standstill in chemicals legislation. Most of the relevant regulations are subject to chronic revisions. In order to keep up with the actual legislation beyond the efforts of a loose-leaf collection, the series CSL: Consolidated Substances Legislation has been created. This is the consolidated version of the European Cosmetics Regulation (April 2014). This is the text of the consolidated version of the EU Biocides Regulation 528/2012.
Table of contents
1. List of corrigenda and amendments considered in this consolidated version
2. Recitals
3. Text of regulation
3.1. CHAPTER I SCOPE AND DEFINITIONS
3.1.1. Article 1 Purpose and subject matter
3.1.2. Article 2 Scope
3.1.3. Article 3 Definitions
3.2. CHAPTER II APPROVAL OF ACTIVE SUBSTANCES
3.2.1. Article 4 Conditions for approval
3.2.2. Article 5 Exclusion criteria
3.2.3. Article 6 Data requirements for an application
3.2.4. Article 7 Submission and validation of applications
3.2.5. Article 8 Evaluation of applications
3.2.6. Article 9 Approval of an active substance
3.2.7. Article 10 Active substances which are candidates for substitution
3.2.8. Article 11 Technical guidance notes
3.3. CHAPTER III RENEWAL AND REVIEW OF APPROVAL OF AN ACTIVE SUBSTANCE
3.3.1. Article 12 Conditions for renewal
3.3.2. Article 13 Submission and acceptance of applications
3.3.3. Article 14 Evaluation of applications for renewal
3.3.4. Article 15 Review of approval of an active substance
3.3.5. Article 16 Implementing measures
3.4. CHAPTER IV GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS
3.4.1. Article 17 Making available on the market and use of biocidal products
3.4.2. Article 18 Measures geared to the sustainable use of biocidal products
3.4.3. Article 19 Conditions for granting an authorisation
3.4.4. Article 20 Requirements for applications for authorisation
3.4.5. Article 21 Waiving of data requirements
3.4.6. Article 22 Content of authorisation
3.4.7. Article 23 Comparative assessment of biocidal products
3.4.8. Article 24 Technical guidance notes
3.5. CHAPTER V SIMPLIFIED AUTHORISATION PROCEDURE
3.5.1. Article 25 Eligibility for the simplified authorisation procedure
3.5.2. Article 26 Applicable procedure
3.5.3. Article 27 Making available on the market of biocidal products authorised in accordance with the simplified authorisation procedure
3.5.4. Article 28 Amendment of Annex I
3.6. CHAPTER VI NATIONAL AUTHORISATIONS OF BIOCIDAL PRODUCTS
3.6.1. Article 29 Submission and validation of applications
3.6.2. Article 30 Evaluation of applications
3.6.3. Article 31 Renewal of a national authorisation
3.7. CHAPTER VII MUTUAL RECOGNITION PROCEDURES
3.7.1. Article 32 Authorisation through mutual recognition
3.7.2. Article 33 Mutual recognition in sequence
3.7.3. Article 34 Mutual recognition in parallel
3.7.4. Article 35 Referral of objections to the coordination group
3.7.5. Article 36 Referral of unresolved objections to the Commission
3.7.6. Article 37 Derogations from mutual recognition
3.7.7. Article 38 Opinion of the Agency
3.7.8. Article 39 Application for mutual recognition by official or scientific bodies
3.7.9. Article 40 Supplementary rules and technical guidance notes
3.8. CHAPTER VIII UNION AUTHORISATIONS OF BIOCIDAL PRODUCTS
3.8.1. SECTION 1 Granting of Union authorisations
3.8.1.1. Article 41 Union authorisation
3.8.1.2. Article 42 Biocidal products for which Union authorisation may be granted
3.8.1.3. Article 43 Submission and validation of applications
3.8.1.4. Article 44 Evaluation of applications
3.8.2. SECTION 2 Renewal of Union authorisations
3.8.2.1. Article 45 Submission and acceptance of applications
3.8.2.2. Article 46 Evaluation of applications for renewal
3.9. CHAPTER IX CANCELLATION, REVIEW AND AMENDMENT OF AUTHORISATIONS
3.9.1. Article 47 Obligation for notification of unexpected or adverse effects
3.9.2. Article 48 Cancellation or amendment of an authorisation
3.9.3. Article 49 Cancellation of an authorisation at the request of the authorisation holder
3.9.4. Article 50 Amendment of an authorisation at the request of the authorisation holder
3.9.5. Article 51 Detailed rules
3.9.6. Article 52 Period of grace
3.10. CHAPTER X PARALLEL TRADE
3.10.1. Article 53 Parallel trade
3.11. CHAPTER XI TECHNICAL EQUIVALENCE
3.11.1. Article 54 Assessment of technical equivalence
3.12. CHAPTER XII DEROGATIONS
3.12.1. Article 55 Derogation from the requirements
3.12.2. Article 56 Research and development
3.12.3. Article 57 Exemption from registration under Regulation (EC) No 1907/2006
3.13. CHAPTER XIII TREATED ARTICLES
3.13.1. Article 58 Placing on the market of treated articles
3.14. CHAPTER XIV DATA PROTECTION AND DATA-SHARING
3.14.1. Article 59 Protection of data held by competent authorities or the Agency
3.14.2. Article 60 Data protection periods
3.14.3. Article 61 Letter of access
3.14.4. Article 62 Data sharing
3.14.5. Article 63 Compensation for data sharing
3.14.6. Article 64 Use of data for subsequent applications
3.15. CHAPTER XV INFORMATION AND COMMUNICATION
3.15.1. SECTION 1 Monitoring and reporting
3.15.1.1. Article 65 Compliance with requirements
3.15.1.2. Article 66 Confidentiality
3.15.1.3. Article 67 Electronic public access
3.15.1.4. Article 68 Record-keeping and reporting
3.15.2. SECTION 2 Information about biocidal products
3.15.2.1. Article 69 Classification, packaging and labelling of biocidal products
3.15.2.2. Article 70 Safety data sheets
3.15.2.3. Article 71 Register for Biocidal Products
3.15.2.4. Article 72 Advertising
3.15.2.5. Article 73 Poison control
3.16. CHAPTER XVI THE AGENCY
3.16.1. Article 74 Role of the Agency
3.16.2. Article 75 Biocidal Products Committee
3.16.3. Article 76 Secretariat of the Agency
3.16.4. Article 77 Appeal
3.16.5. Article 78 The budget of the Agency
3.16.6. Article 79 Formats and software for submission of information to the Agency
3.17. CHAPTER XVII FINAL PROVISIONS
3.17.1. Article 80 Fees and charges
3.17.2. Article 81 Competent authorities
3.17.3. Article 82 Committee procedure
3.17.4. Article 83 Exercise of the delegation
3.17.5. Article 84 Urgency procedure
3.17.6. Article 85 Adaptation to scientific and technical progress
3.17.7. Article 86 Active substances included in Annex I to Directive 98/8/EC
3.17.8. Article 87 Penalties
3.17.9. Article 88 Safeguard clause
3.17.10. Article 89 Transitional measures
3.17.11. Article 90 Transitional measures concerning active substances evaluated under Directive 98/8/EC
3.17.12. Article 91 Transitional measures concerning applications for biocidal product authorisations submitted under Directive 98/8/EC
3.17.13. Article 92 Transitional measures concerning biocidal products authorised/registered under Directive 98/8/EC
3.17.14. Article 93 Transitional measures concerning biocidal products not covered by the scope of Directive 98/8/EC
3.17.15. Article 94 Transitional measures concerning treated articles
3.17.16. Article 95 Transitional measures concerning access to the active substance Dossier
3.17.17. Article 96 Repeal
3.17.18. Article 97 Entry into force
Purpose and Main Themes
The primary purpose of Regulation (EU) No 528/2012 is to improve the functioning of the internal market for biocidal products while maintaining a high level of protection for both human and animal health and the environment. It establishes a comprehensive legal framework for the approval of active substances and the subsequent authorisation of biocidal products, replacing previous directives to ensure clear, harmonised rules across the European Union.
- Harmonisation of regulations for the making available on the market and use of biocidal products.
- Procedures for the approval of active substances and authorisation of biocidal products.
- Establishment of the European Chemicals Agency (ECHA) role in the coordination and management of biocidal product authorisations.
- Rules for mutual recognition of authorisations to facilitate trade within the EU.
- Special considerations for low-risk substances and the replacement of hazardous active substances (candidates for substitution).
- Provisions for treated articles to ensure safety and consumer information.
Excerpt from the Book
Article 1 Purpose and subject matter
1. The purpose of this Regulation is to improve the functioning of the internal market through the harmonisation of the rules on the making available on the market and the use of biocidal products, whilst ensuring a high level of protection of both human and animal health and the environment. The provisions of this Regulation are underpinned by the precautionary principle, the aim of which is to safeguard the health of humans, the health of animals and the environment. Particular attention shall be paid to the protection of vulnerable groups.
2. This Regulation lays down rules for:
(a) the establishment at Union level of a list of active substances which may be used in biocidal products;
(b) the authorisation of biocidal products;
(c) the mutual recognition of authorisations within the Union;
(d) the making available on the market and the use of biocidal products within one or more Member States or the Union;
(e) the placing on the market of treated articles.
Summary of Chapters
CHAPTER I SCOPE AND DEFINITIONS: Defines the purpose, subject matter, and scope of the Regulation, including exclusions and key terminology.
CHAPTER II APPROVAL OF ACTIVE SUBSTANCES: Outlines the criteria and procedures for approving active substances, including exclusion criteria and candidate for substitution status.
CHAPTER III RENEWAL AND REVIEW OF APPROVAL OF AN ACTIVE SUBSTANCE: Specifies the conditions and procedural steps for renewing or reviewing existing approvals of active substances.
CHAPTER IV GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS: Establishes fundamental requirements for biocidal products and the sustainable use of these products.
CHAPTER V SIMPLIFIED AUTHORISATION PROCEDURE: Provides a faster path for biocidal products that meet specific low-risk conditions.
CHAPTER VI NATIONAL AUTHORISATIONS OF BIOCIDAL PRODUCTS: Describes the process for obtaining national-level authorisations for biocidal products.
CHAPTER VII MUTUAL RECOGNITION PROCEDURES: Details mechanisms for expanding authorisations across multiple EU Member States.
CHAPTER VIII UNION AUTHORISATIONS OF BIOCIDAL PRODUCTS: Covers the procedure for obtaining a single authorisation valid throughout the European Union.
CHAPTER IX CANCELLATION, REVIEW AND AMENDMENT OF AUTHORISATIONS: Sets forth rules for updating, reviewing, or cancelling existing product authorisations.
CHAPTER X PARALLEL TRADE: Facilitates the movement of identical biocidal products between Member States.
CHAPTER XI TECHNICAL EQUIVALENCE: Defines the process for establishing that a substance is equivalent to an already approved one.
CHAPTER XII DEROGATIONS: Specifies emergency situations or specific contexts where standard requirements can be waived.
CHAPTER XIII TREATED ARTICLES: Sets rules for articles that have been treated with or incorporate biocidal products.
CHAPTER XIV DATA PROTECTION AND DATA-SHARING: Outlines rules to prevent unnecessary testing on animals and protection of proprietary data.
CHAPTER XV INFORMATION AND COMMUNICATION: Discusses monitoring, reporting, confidentiality, and public access to information.
CHAPTER XVI THE AGENCY: Defines the role and tasks of the European Chemicals Agency in the implementation of this Regulation.
CHAPTER XVII FINAL PROVISIONS: Includes regulations on fees, penalties, transitional measures, and the repealing of previous legislation.
Keywords
Biocidal products, active substances, Regulation (EU) No 528/2012, European Chemicals Agency, authorisation, mutual recognition, risk assessment, human health, environment, substitution, treated articles, data protection, sustainability, safety, classification and labelling.
Frequently Asked Questions
What is the primary objective of Regulation (EU) No 528/2012?
The main objective is to unify the regulatory landscape for biocidal products across the European Union, ensuring that these products are safe for human health, animal health, and the environment while allowing for the free movement of goods.
Which entities are involved in the authorisation process?
The process involves applicants, the European Chemicals Agency (ECHA), the European Commission, and the national competent authorities of the respective EU Member States.
How does the Regulation address animal welfare?
The Regulation emphasizes the reduction of animal testing by mandating the sharing of existing data and using alternative test methods where possible, with testing on vertebrates considered a last resort.
What is the role of the Biocidal Products Committee?
This committee, established within the Agency, is responsible for preparing opinions on matters such as active substance approvals, Union authorisations, and other scientific/technical questions referred to it.
What is a "candidate for substitution"?
These are active substances with certain hazardous properties that necessitate a comparative assessment during the authorisation process to determine if less harmful alternatives exist.
What are the provisions for "treated articles"?
Treated articles are items that incorporate or have been treated with a biocidal product; they must be labelled appropriately to inform the consumer about the biocidal treatment and any associated risks.
How are fees determined for the authorisation process?
Fees are set by the Commission (for the Agency) and by individual Member States, designed to cover the costs of the services provided, while often taking into account the specific needs of small and medium-sized enterprises (SMEs).
Are there special arrangements for existing active substances?
Yes, there is a transitional work programme for the systematic examination of existing active substances, allowing them to remain on the market until a final decision is reached on their approval.
What happens if a Member State refuses an authorisation?
Disagreements are managed through the coordination group; if the group cannot reach an agreement, the issue may be referred to the Commission for a final decision.
Can a product be authorized under both national and Union systems?
The Union authorisation serves as an alternative for certain categories of biocidal products, providing direct access to the entire Union market, whereas national authorisation is focused on the territory of one or more specific Member States.
- Quote paper
- Stefanie Merenyi (Author), 2014, Biocides: Regulation (EU) No 528/2012, Munich, GRIN Verlag, https://www.grin.com/document/274360
