The Notification of New Substances Regulations 1993

1. Introductory Text

2. PART I INTERPRETATION AND GENERAL

   1. 1. Citation and commencement

   2. 2. Interpretation

   3. 3. Application

3. PART II NOTIFICATIONS

   1. 4. Full notifications

   2. 5. Requirements for further testing for substances notified under regulation 4

   3. 6. Reduced notification requirements for substances placed on the market in quantities of less than one tonne per year by a single manufacturer

   4. 7. Notifications relating to polymers

   5. 8. Placing of notified substances on the market

   6. 9. Requirements for further information

   7. 10. Follow up information

   8. 11. Notification of substances previously notified

   9. 12. Substances manufactured outside the Communities

   10. 13. Further notification of the same substance and avoidance of duplication of testing on vertebrate animals

   11. 14. Tests under these Regulations to conform to the principles of good laboratory practice

   12. 15. Notifications and reports to be in English

4. PART III RIGHTS AND DUTIES OF THE COMPETENT AUTHORITY

   1. 16. Risk assessments

   2. 17. Information to be sent by the competent authority to the European Commission

5. PART IV DISCLOSURE OF INFORMATION

   1. 18. Disclosure of information provided under Part II of these Regulations

   2. 19. Treatment of confidential information

   3. 20. Substances appearing in the list of notified substances

6. PART V MISCELLANEOUS AND GENERAL

   1. 21. Enforcement and civil liability

   2. 22. Prohibition of importation and placing on the market of unnotified substances

   3. 23. Exemption certificates

   4. 24. Fees for notifications etc.

   5. 25. Revocations, amendments and transitional provisions

7. Signature

8. 1. SCHEDULE 1

      CHARACTERISTIC PROPERTIES OF DANGEROUS SUBSTANCES

      1. PART I categories of danger and characteristic properties

      2. PART II criteria for the categories of danger “very toxic”, “toxic” and “harmful”

   2. SCHEDULE 2

      (This Schedule sets out the provisions of Annex VII to the Directive)

      1. PART A information required for the technical dossier for a full notification under regulation 4(1)

      2. PART B information required for the technical dossier for a notification under regulation 6(1)

      3. PART C information required for the technical dossier for a notification under regulation 6(2)

      4. PART D (The provisions set out in this Part were introduced into Annex VII of the Directive by Commission Directive 1993/105/EEC)information required for the technical dossier for a notification under regulation 7

   3. SCHEDULE 3

      (This Schedule sets out the provisions of Annex VIII to the Directive)

      1. LEVEL 1

         1. Physico-chemical studies

         2. Toxicological studies

         3. Ecotoxicity studies

      2. LEVEL 2

         1. Toxicological studies

         2. Ecotoxicological studies

   4. SCHEDULE 4

      FEES FOR NOTIFICATIONS ETC.

9. Explanatory Note