1. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Training on standardisation Support to the Modernisation of the Mongolia’s Standardisation System (SMMSS) The Cosmetics legislation as an example of EU “Old Approach” legislation

2. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN The Cosmetics legislation as an example of EU “Old Approach” legislation Introduction and Context: EU has different kinds of legislation. Here is some explanation. 1. EU Directives – these direct those to whom they are directed – e.g. EU Member States - to act in accordance with their provisions. With Member States it includes power to direct them to change their national laws to bring them into line with the provisions of the Directives and thus establish harmonization across the EU.

3. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Context - continued EU Regulations – these are directly-applicable law across the EU – they need no national legislation to transpose them but usually have consequences for national law which will require complementary national legislation to: 1.Remove existing legislation that conflicts with the legislation (could be either law of national origin or earlier EU-based legislation that is being replaced) 2.Appoint Market Surveillance Authorities with powers to ensure compliance with the law and penalties on suppliers for non-compliance 3.Any other necessary provisions

4. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Context (continued) EU Decisions – these are not laws in themselves but are binding on those to whom they are addressed and can commit them to introduce law in line with their provisions e.g. EU New Legislative Framework consists of: Regulation 765/2008/EC on Accreditation and Market Surveillance – directly applicable Decision 768/2008/EC on a common framework for the marketing of products – commits the E. Commission, E. Parliament & Member States to remodel existing EU product marketing legislation in line with its provisions

5. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Examples of different kinds of legislation Legislation to achieve minimum safety protection levels across the EU e.g the General Product Safety Directive 2001/95/EC Legislation designed to remove or prevent Technical Barriers to Trade across the EU by harmonizing public protection requirements: “Old Approach” legislation – details on following slides “New Approach” legislation – see separate presentation Framework legislation that authorises the use of international standards or agreements as the basis of manufacture e.g. much of the EU’s motor vehicle legislation – a kind of “Old Approach” legislation

6. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Old Approach legislation “Old Approach” legislation: Its notable feature is that it contains key technical specifications for public protection within the legislation itself even if it also uses standards as well. This is in contrast to: “New Approach” which in terms of Requirements for public protection, e.g for health & safety, confines itself to goal-setting Essential Requirements legislation, and leaves the technical specifications to meet those requirements to European harmonizing standards

7. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Cosmetics legislation as an example of Old Approach From 1976 to 2009, this was the legislation was the Cosmetics Directive 76/768/EEC. Along with certain other legislation, it provided the basis for the marketing of cosmetics using safe ingredients, across the EU. Replaced by the Cosmetics Regulation 1229/2009/EC, which - with certain other legislation - now provides the basis for the marketing of cosmetics with safe ingredients, across the EU

8. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN The Cosmetic Regulation Although the new legislation is a Regulation in contrast to the former, which was a Directive, it is still basically Old Approach, even though standardization plays a part in the legislative system. Let’s look at its structure

9. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Overall structure 1. 71 Recitals – Recitals are not in themselves legislative provisions – they explain the purpose of the legislation and help to interpret its substantive provisions 2. 40 Articles that are divided into 10 Chapters (Articles use Arabic numerals, Chapters use Roman ones). Articles are substantive law, i.e. the provisions are binding – they must be complied with 3. 9 Annexes, which the Articles make substantive law, too.

10. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Structure of the Cosmetics Regulation in detail - 1 Recitals CHAPTER I (Articles 1&2) Scope & Definitions CHAPTER II (Articles 3-9) Safety, Responsibility & Free Movement CHAPTER III (Articles 10-13) Safety Assessment, Product Information File & Notification CHAPTER IV (Articles 14-17) Restrictions for certain substances CHAPTER V (Articles 18) Animal Testing

11. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Structure of the Cosmetics Regulation in detail - 2 CHAPTER VI (Articles 19-21) Consumer Information CHAPTER VII (Articles 22-24) Market Surveillance CHAPTER VIII (Articles 25-28) Non-Compliance; Safeguards Clause CHAPTER IX (Articles 29-30) Administrative Cooperation CHAPTER X (Articles 31-40) Implementing Measures & Final Provisions

12. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Structure of the Cosmetics Regulation in detail - 3 (Annexes) Annex I – Cosmetic Products Safety Report Annex II – List of substances prohibited in cosmetic products (44 pages) Annex III – List of substances which cosmetic products must not contained except subject to the restrictions laid down (48 pages) Annex IV – List of colorants allowed in cosmetic substances (16 pages) Annex V – List of preservatives allowed in cosmetic substances (9 pages)

13. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Structure of the Cosmetics Regulation in detail -4 (Annexes) Annex VI – List of UV filters allowed in cosmetic products (2 pages) Annex VII – Symbols used on packaging/ container Annex VIII – List of validated alternative methods to animal testing Annex IX Part A – Repealed Directive with its successive amendments Part B - List of time-limits for transposition into national law and application

14. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN New Amendment Procedure Since the changes to the Treaty of European Union brought about by the Treaty of Lisbon, it is possible for legislation to specify that it can be amended by a more streamlined procedure known as: Regulatory Procedure with Scrutiny, i.e. European Commission can amend “non- essential” provisions after consulting an expert scientific committee unless European Parliament or the Council (of EU member states) raise objections in a prescribed manner This has been adopted for this Regulation - used nine times under the Regulation to date

15. Support for the Modernisation of the Mongolian Standardisation system – EuropeAid/134305/C/SER/MN Thank you for your kind attention Richard Lawson richardandrosemary@btinternet.com Support to the Modernisation of the Mongolian Standardisation System (SMMSS) This project is supported by the European Union