http://www.legislation.gov.uk/uksi/1993/3050/contents/made

The Notification of New Substances Regulations 1993

Health and safety at work

Hazardous substances

King's Printer of Acts of Parliament

2015-05-12

HEALTH AND SAFETY

These Regulations implement—as respects Great Britain the provisions of Council Directive 92/32/EEC (OJ No. L154, 5.6.92, p.1) (“the Directive”) amending for the 7th time Council Directive 67/548/EEC (OJ No.196, 16.8.67, p. 1, (OJ/SE1967, p. 234)) relating to the classification, packaging and labelling of dangerous substances insofar as those provisions relate to the placing on the market of new substances together with Commission Directive 93/105/EEC setting out Annex VIID of the Directive (relating to polymers); andas respects the United Kingdom, the provisions of the Directive relating to the importation of new substances into the United Kingdom.

The Notification of New Substances Regulations 1993

reg. 2(1)

The Good Laboratory Practice Regulations 1997

reg. 18(a)

reg. 1

The Notification of New Substances Regulations 1993

reg. 4(b)

The Good Laboratory Practice Regulations 1997

reg. 18(b)

reg. 1

The Notification of New Substances Regulations 1993

reg. 5(2)

The Good Laboratory Practice Regulations 1997

reg. 18(c)

reg. 1

The Notification of New Substances Regulations 1993

reg. 14(1)

The Good Laboratory Practice Regulations 1997

reg. 18(d)

reg. 1

The Notification of New Substances Regulations 1993

reg. 14(4)

The Good Laboratory Practice Regulations 1997

reg. 18(e)

reg. 1

The Notification of New Substances Regulations 1993

reg. 2(1)

The Chemicals (Hazard Information and Packaging for Supply) Regulations 1994

reg. 19(8)(a)

reg. 1

The Notification of New Substances Regulations 1993

reg. 4(d)

The Chemicals (Hazard Information and Packaging for Supply) Regulations 1994

reg. 19(8)(b)

reg. 1

The Notification of New Substances Regulations 1993

reg. 6(7)

The Chemicals (Hazard Information and Packaging for Supply) Regulations 1994

reg. 19(8)(b)

reg. 1

The Notification of New Substances Regulations 1993

reg. 18(3)(h)

The Chemicals (Hazard Information and Packaging for Supply) Regulations 1994

reg. 19(8)(b)

reg. 1

The Notification of New Substances Regulations 1993

Sch 2

Pt A

The Notification of New Substances (Amendment) Regulations 2002

reg 3(1)

The Notification of New Substances Regulations 1993

Sch 3

The Notification of New Substances (Amendment) Regulations 2002

reg 3(2)

The Notification of New Substances Regulations 1993

defn(s)

The Health and Safety (Fees) Regulations 2002

reg 18(1)

(3)

The Notification of New Substances Regulations 1993

Sch. 2

para. 7.3(g)

The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2004

Sch. 13

para. 7

reg. 1

The Notification of New Substances Regulations 1993

reg. 2(1)

The Good Laboratory Practice (Codification Amendments Etc.) Regulations 2004

reg. 5

reg. 1

The Notification of New Substances Regulations 1993

reg 3

The Notification of New Substances (Amendment) Regulations 2001

reg 3

The Notification of New Substances Regulations 1993

defn(s)

Health and Safety (Fees) Regulations 2003

reg 18

The Notification of New Substances Regulations 1993

reg. 3(2)(i)

The Export and Import of Dangerous Chemicals Regulations 2008

reg. 5(2)

reg. 1(1)

The Notification of New Substances Regulations 1993

Regulations

The REACH Enforcement Regulations 2008

Sch. 10

Pt. 2

The Notification of New Substances Regulations 1993

reg. 3(2)(e)

The Ionising Radiations Regulations 1999

Sch. 9

para. 4

reg. 3

reg. 1(a)

The Notification of New Substances Regulations 1993

reg.24

Sch.4

The Health and Safety (Fees) Regulations 1995

reg.17

Sch.14

The Notification of New Substances Regulations 1993

reg. 3(2)(i)

The Export and Import of Dangerous Chemicals Regulations 2005

reg. 5(2)

reg. 1(1)

The Notification of New Substances Regulations 1993

Sch. 2

Pt. A

The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2007

Sch. 8

reg. 1

The Notification of New Substances Regulations 1993

PART IINTERPRETATION AND GENERAL

1Citation and commencement

5Requirements for further testing for substances notified under regulation 4

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

7Notifications relating to polymers

8Placing of notified substances on the market

9Requirements for further information

10Follow up information

11Notification of substances previously notified

12Substances manufactured outside the Communities

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

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

15Notifications and reports to be in English

PART IIIRIGHTS AND DUTIES OF THE COMPETENT AUTHORITY

16Risk assessments

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

PART IVDISCLOSURE OF INFORMATION

18Disclosure of information provided under Part II of these Regulations

19Treatment of confidential information

20Substances appearing in the list of notified substances

PART VMISCELLANEOUS AND GENERAL

21Enforcement and civil liability

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

23Exemption certificates

24Fees for notifications etc.

25Revocations, amendments and transitional provisions

SCHEDULE 1CHARACTERISTIC PROPERTIES OF DANGEROUS SUBSTANCES

PART Icategories of danger and characteristic properties

PART IIcriteria for the categories of danger “very toxic”, “toxic” and “harmful”

SCHEDULE 2(This Schedule sets out the provisions of Annex VII to the Directive)

PART Ainformation required for the technical dossier for a full notification under regulation 4(1)

PART Binformation required for the technical dossier for a notification under regulation 6(1)

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

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

SCHEDULE 3(This Schedule sets out the provisions of Annex VIII to the Directive)

LEVEL 1

Physico-chemical studies

Toxicological studies

Ecotoxicity studies

LEVEL 2

Toxicological studies

Ecotoxicological studies

SCHEDULE 4FEES FOR NOTIFICATIONS ETC.

1993 No. 3050

HEALTH AND SAFETY

The Notification of New Substances Regulations 1993

Made15th December 1993

Laid before Parliament23rd December 1993

Coming into force31st January 1994

The Secretary of State, being the designated1 Minister for the purpose of section 2(2) of the European Communities Act 19722 in relation to the notification and control of substances, in the exercise of the powers conferred on him by the said section 2(2) and sections 15(1), (2), (3)(c), (4)(a) and (5)(b), 43(2), (4) and (5) and 82(3)(a) of, and paragraphs 1(1)(b), (4) and (5), 2, 15(1) and 16 of Schedule 3 to, the Health and Safety at Work etc.Act 19743 (“the 1974 Act”) and of all other powers enabling him in that behalf for the purpose of giving effect without modifications to proposals submitted to him by the Health and Safety Commission under section 11(2)(d) of the 1974 Act after the carrying out by the said Commission of consultations in accordance with section 50(3) of that Act, hereby makes the following Regulations:—