proposals for the chemical (hazard information and...

This consultative document is issued by the Health and Safety Executive in compliance with its duty to consult under section 16(2) of the Health and Safety at Work etc Act 1974.

Comments should be sent to:

Jan HarrisPolicy AdviserInternational Chemicals UnitHealth and Safety Executive9th Floor, South WingRose Court2 Southwark BridgeLondon SE1 9HS

Tel: 020 7717 6251 Fax: 020 7717 6891

E-mail: [email protected]

to reach there no later than 13 February 2009

The Executive tries to make its consultation procedure as thorough and open as possible. Responses to this consultative document will be lodged with the Health and Safety Executive’s Knowledge Centre after the close of the consultation period where they can be inspected by members of the public or be copied to them on payment of the appropriate fee to cover costs.

Responses to this consultative document are invited on the basis that anyone submitting them agrees to their response being dealt with in this way. Responses, or part of them, will be withheld from the Knowledge Centre only at the express request of the person making them. In such cases, a note will be put in the index to the responses identifying those who have commented and have asked that their views, or part of them, be treated as confidential.

Many business e-mail systems now automatically append a paragraph stating the message is confidential. If you are responding to this CD by e-mail and you are content for your responses to be made publicly available, please make clear in the body of your response that you do not wish any standard confidentiality statement to apply.

Health and Safety Executive

Proposals for the Chemical (Hazard Information and Packaging for Supply) Regulations 2009 – CHIP 4

CD220Consultative Document

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PROPOSALS FOR THE CHEMICAL (HAZARD INFORMATION AND PACKAGING FOR

SUPPLY) REGULATIONS 2009 – CHIP 4

CONTENTS

Page(s)

ii Preface

iii Executive Summary

1 Introduction / Background

4 Proposals for the Chemical (Hazard Information and Packaging for Supply) Regulations 2009

10 Impact assessment / Invitation to comment

13 Appendix I – Questionnaire

19 Appendix II – Short Impact Assessment

31 Appendix III – List of consultees

39 Appenndix IV – Draft Chemicals (Hazard Information and Packaging for Supply) Regulations 2009

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PREFACE

The Health and Safety Executive (HSE) would like your comments on new Regulations proposed by the Board of the HSE to revoke and replace the Chemicals (Hazard Information and Packaging for Supply) Regulations 2002 (CHIP 3), as amended. These are sometimes referred to as CHIP. The new Regulations will be known as the Chemicals (Hazard Information and Packaging for Supply) Regulations 2009 (CHIP 4).

Please note that this consultation focuses on the proposed amendments to the CHIP Regulation that need to be made as a consequence of the CLP Regulation. It is not intended to re-open consultation on the provisions and impact of the CLP Regulation, which was subject to extensive consultation during 2007 and throughout formal negotiations.1

A response form is included at Appendix I at the back of this booklet to help you do this. Please feel free to circulate this consultative document more widely. You can download this document from the Internet on the HSE home page at:

http:www.hse.gov.uk/consult/live.htm

If you are reading this document on a computer screen and would prefer a printed version, it can be obtained on request. Furthermore, if you require a more accessible format, an Executive Summary is available in Braille, large print, disc, audio cassette or in another language. Please contact Jan Harrisat the address given in paragraph 50.

Acknowledgements:

HSE wishes to thank all those who have assisted with the development of these proposals.

Why are we consulting you?

HSE seeks to inform its decision-making by consulting a wide range of interested bodies and individuals. HSE believes that this will enable an open and transparent approach to decision-making, which is essential if policies and decisions are to have widespread ownership and reflect the needs and aspirations of the people they will affect. HSE then decides on the best way forward based on an interpretation and analysis of the results of this exercise.

1 See http://www.hse.gov.uk/consult/condocs/cd213.htm

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EXECUTIVE SUMMARY

1. The Chemicals (Hazard Information and Packaging for Supply) Regulations 2002 (CHIP 3) need to be amended as a consequence of the adoption and entry into force of the European Regulation on the Classification, Labelling and Packaging of Substances and Mixtures, known as the CLP Regulation.

2. The CLP Regulation adopts in the European Union, the internationally agreed Global Harmonised System on the classification and labelling of chemicals, known as the ‘GHS’. The GHS establishes a framework for describing and communicating the hazardous properties of chemicals for both transport and supply.

3. The GHS sets out internationally accepted definitions and criteria toidentify the hazards of chemicals (called ‘classification’) and communicate these hazards via labels and safety data sheets. If the same classification criteria and labelling are used to describe the hazards, the level of protection of human health and the environment becomes more consistent, transparent and comparable throughout the world. Professional suppliers and users of chemicals, and consumers all over the world benefit from such harmonisation.

4. The GHS was endorsed at the World Summit in Johannesburg in 2002, with a commitment for countries to adopt the GHS in national legislation by 2008. The European Commission responded to this commitment by proposing the CLP Regulation to adopt and apply the principles and criteria of GHS throughout the European Union.

5. The CLP Regulation is expected to enter into force in all EU Member States late 2008/early 2009. With suitable transitional arrangements, the CLP Regulation repeals the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC).

6. Although the CLP Regulation will be directly acting on Member States, without the need for transposition, HSE needs to make the necessary amendments to the CHIP Regulations to accommodate the changes at European level. The proposed amendments are designed to allow the relevant domestic legislation to be aligned with the transitional period of the CLP Regulation, in preparation for the its repeal in 2015, and to ensure that the provisions of the CLP Regulation can be enforced in Great Britain, both throughout the transitional period and beyond.

7. To achieve this HSE proposes a number of amendments to the existing CHIP Regulations and to reissue them in a consolidated version (CHIP 4). As well as incorporating the necessary enforcing provisions, CHIP 4 will also: allow duty holders to apply the provisions of the CLP Regulation, as an alternative to CHIP, during the transitional period where they choose to do so, prior to the mandatory compliance

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deadlines for substances and mixtures of 1 December 2010 and 1 June 2015; implement the outstanding provisions of Directive 2006/121/EC; incorporate the necessary ambulatory references to enable GB law to remain aligned with relevant European law without the need for constant amendment; incorporate key terminology changes; and to make two minor editorial changes to ensure CHIP refers to correct legislation.

8. It is proposed to bring the new CHIP Regulations into force in GB on 6April 2009.

Administrative Arrangements

9. The enforcement regime will be GB wide and existing enforcing authorities, currently responsible for CHIP 3, will enforce the proposed new CHIP 4 Regulations.

Impact Assessment

10.An initial Impact Assessment, set out at Appendix II, indicates that the costs of implementing these amendments will be minimal.

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INTRODUCTION

1. Chemicals often have harmful or hazardous properties. People and/or the environment may suffer adverse effects from exposure to these properties. As a result, many countries have developed laws that require certain controls to be in place when supplying and using chemicals that could cause harm, to ensure the protection of people and the environment. Although existing laws and regulations around the world to identify and communicate the hazardous properties of chemicals are similar in many respects, their differences are significant enough to result in different classifications, labels or safety data sheets,for the same product in different countries. This affects both the level of protection and the extensive global trade in chemicals.

BACKGROUND

2. At the Earth Summit held in Rio de Janeiro in 1992, world leaders generated an international mandate, set out in Agenda 21 of the United Nations Conference on Environment and Development, to make available “a globally harmonised hazard classification and compatible labelling system, including material safety data sheets and easily understandable symbols”.

3. A number of key principles of harmonisation were agreed at an early stage, including a commitment that:

“the level of protection offered to workers, consumers, the generalpublic and the environment [provided by existing systems] shouldnot be reduced as a result of harmonizing the [different]classification and labelling systems”2.

4. The UN GHS sets out internationally accepted definitions and criteria to identify the hazards of chemicals (called ‘classification’) and communicate these hazards via labels and safety data sheets. If the same classification criteria and labelling are used to describe the hazards, the level of protection of human health and the environment becomes more consistent, transparent and comparable throughout the world. Professional suppliers and users of chemicals and consumers all over the world will benefit from such harmonisation.

5. The outcome is a set of agreed definitions and criteria to identify the hazardous properties of chemicals – known as ‘the GHS’3. The GHS includes:

2Globally Harmonized System of Classification and Labelling of Chemicals (GHS), First

revised edition, UNITED NATIONS, New York and Geneva, 2005, p.4

3 The GHS is available at: www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html

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• the hazard class - .this refers to the nature of the physical, health or environmental hazard;

• the hazard category - this refers to the severity of the hazard within each hazard class;

• pictograms – hazard symbols;• signal words – these refer to the relative severity of the hazard

present for example: “danger” or “warning”;• hazard statements and precautionary statements – phrases that

describe the nature of the hazard and the recommended measures to minimise or prevent the adverse effects from exposure due to its use.

6. The UK and other EU Member States contributed significantly to the development of the UN agreement and there are many similarities between GHS and the existing EU system. These include:

• a single system for hazard classification and labelling of both substances and mixtures (preparations) for supply;

• coverage of virtually all hazards which are currently covered by the EU system (and allows additional hazards if they are not covered by the GHS, for example, the EU requirement to classify ‘hazardous to the ozone layer);

• broadly similar classification criteria;• broadly equivalent system of hazard communication consisting of

both labels and safety data sheets (for workers). Under the GHS, safety data sheets also have the same 16 headings as in the current EU system.

7. The UN anticipates that, once fully implemented, the GHS will:

• enhance the protection of human health and the environment by providing an internationally comprehensible system for hazard communication;

• provide a recognised framework for those countries without an existing system;

• reduce the need for testing and evaluation of chemicals; and• facilitate trade in chemicals whose hazards have been properly

assessed and identified on an international basis4.

8. The GHS is a voluntary international agreement and therefore countries must introduce implementing legislation in order to make the GHS requirements mandatory. Countries or jurisdictions may act alone or in groups or trading blocks to take this work forward.

4Globally Harmonized System of Classification and Labelling of Chemicals (GHS), second

revised edition, UNITED NATIONS, New York and Geneva, 2007 ISBN -13: 978-92-1-116957-7

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Classification, Labelling and Packaging of Substances and Mixtures Regulation (the CLP Regulation)

9. As the classification and labelling of chemicals in Europe is already regulated at Community level rather than national level, the European Commission, on behalf of European Member States, produced a new European Regulation on Classification, Labelling and Packaging of Substances and Mixtures, known as the CLP Regulation. The CLP Regulation will adopt the principles and criteria of the GHS in the EU and will be direct acting on all Member States.

10.During negotiations the CLP Regulation was carefully considered to ensure that it achieved the intended objectives of contributing to a globally harmonised system that can operate effectively in the EU. Its aims are to secure the trade benefits of the GHS in terms of harmonised classification and labelling, to limit the costs to UK industry by keeping the scope of the new system broadly in line with the present one, and, by ensuring workable transitional arrangements, to migrate from the existing system to the new GHS criteria.

11.However, the introduction of the CLP Regulation will mean some new:

• scientific criteria to identify hazardous properties of chemicals• hazard warning pictograms (symbols) and new standardised

warning and precautionary text for labels• terminology, e.g. ‘mixtures’ instead of ‘preparations’, ‘hazardous’

instead of ‘dangerous’, ‘hazard statement’ instead of ‘risk phrase’ and ‘precautionary statement’ instead of ‘safety phrase’.

Transitional arrangements

12.Practical, workable arrangements for migrating from the existing EU system to the GHS criteria are essential, as industry will have to review and adjust, as necessary, the classifications and labels for chemicals placed on the EU market.

13.The CLP Regulation sensibly proposes a two stage process in which substances are re-classified first, over a 2 year period (until 1 December 2010), and then mixtures over a further 4 � years (until 1 June 2015).

14.The transitional period is expected to start at the end of 2008/early 2009, once the CLP Regulation enters into force.

Consultation on the CLP Regulation

15.The HSC consulted stakeholders on the new CLP Regulation. Consultative Document (CD) No 213 was published on 14 August 2007. Consultation closed on 2 November 2007. The CD set out an introduction to the systems for the classification and labelling of

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chemicals (both the current EU one and the GHS), an indication of key issues for the UK, the proposed Regulation text together with its technical annexes, and an initial Regulatory Impact Assessment (RIA).

16.The majority of respondents supported the adoption of the GHS by the CLP Regulation. The full CD and final Regulatory Impact Assessment can be found at http://www.hse.gov.uk/consult/condocs/cd213.htm

PROPOSALS FOR THE CHEMICAL (HAZARD INFORMATION AND PACKAGING FOR SUPPLY) REGULATIONS – CHIP 4

17.In Great Britain the Chemicals (Hazard Information and Packaging for Supply) Regulations 2002, implement the existing EU classification and labelling regime, governed by the Dangerous Substances Directive, the Dangerous Preparations Directive and the Safety Data Sheets Directive (the latter now being subsumed by the REACH Regulation). CHIP also sets out the necessary enforcement provisions.

Proposed amendments to CHIP Regulations

18.The adoption and entry into force of the CLP Regulation means that we have to make some adjustment to the CHIP Regulations. Although the CLP Regulation will act directly on Member States, including the UK, certain changes are needed in a number of areas to ensure that domestic legislation keeps in line with the changes at European level.

Proposed Amendment 1 – compliance with the CLP Regulation

19.The CLP Regulation will introduce requirements for chemical classification, labelling and packaging that will differ slightly from those in CHIP. These new requirements will enter into force over a phased transitional period, ultimately replacing CHIP and its parent European legislation in June 2015. CHIP, therefore, needs to be amended to require compliance with CLP, for substances from 1 December 2010 and for mixtures from 1 June 2015.

20.However, suppliers can comply with the provisions of the CLP Regulation, as an alternative to CHIP, from the date on which the Regulation enters into force. In practice, many suppliers will wish to make the changes to the GHS system well before the formal deadlines. The specific transitional arrangements are as follows:

Substances

Entry into force (late 2008/early 2009) – 1st

December 2010

Suppliers must classify substances according to CHIP, and may continue to label them according to CHIP. However they may label according to CLP, in which case they must classify according to CLP in addition to CHIP.

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1st December 2010 – 1st June 2015

Suppliers must classify substances according to both CHIP and CLP. They must label according to CLP.

1st June 2015 onwards

Suppliers must classify and label according to CLP

Mixtures

Entry into force (late 2008/early 2009) – 1st June 2015

Suppliers must classify mixtures according to CHIP, and may continue to label them according to CHIP. However they may label according to CLP, in which case they must classify according to CLP in addition to CHIP.


Suppliers must classify and label according to CLP.

21.We are proposing to amend CHIP to allow early compliance with the CLP Regulation from the date of entry into force until the end of the transitional periods for substances and mixtures respectively, as well as amendments to require compliance with the CLP Regulation instead of CHIP 4 by the deadlines of 1 December 2010 and 1 June 2015 for substances and mixtures respectively.

22.A further proposed amendment is incorporated in CHIP to ‘switch off’ all CHIP Regulations, with the exception of the enforcement provisions, when the CLP Regulation is fully mandatory from 1st June 2015.

Question 1 - Do you agree with the proposals to amend CHIP to allow compliance with the CLP Regulation (proposed Amendment 1)?

Proposed Amendment 2 – enforcement of the CLP Regulation

23.The current classification and labelling regime is enforced under the provisions of Regulation 14 of CHIP. Regulation 14 draws on the relevant provisions of the Health and Safety at Work etc Act 1974 and the European Communities Act 1972. These provisions empower the relevant enforcing authorities to take action against those suppliers of dangerous chemicals who fail to meet their duties under CHIP regarding the classification, packaging and provision of information to users. However, these provisions do not extend to enforcement of the duties under the CLP Regulation.

24.Article 43 of the CLP Regulation states: “Member States shall appoint ……….. the authorities responsible for the enforcement of the obligations set out in this regulation.” How enforcing authorities carry out the duty placed on them is at their discretion. The CLP Regulation does not specify any particular level of activity for the enforcing authorities and this will depend on Member States’ enforcement programmes and resources.

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25.In considering enforcement of the CLP Regulation, we took as our starting point the existing enforcement regime for CHIP which aims to ensure:

• effective compliance as failure to comply with CLP can have serious consequences for the environment or health.

• that where compliance is lacking, the enforcing authorities should have the necessary powers to ensure compliance without the need for prosecution. Therefore, the enforcing authorities should all have powers to serve notices setting out any non-compliance or anticipated non-compliance. Failure to comply with a notice will be a criminal offence.

• that prosecutions can be brought as a measure of last resort. • that there are effective and dissuasive penalties for a breach of the

Regulation. • the enforcement regime is compliant with Hampton principles of

inspection and enforcement. • that a consistent approach is achieved (in so far as possible)

throughout GB.

26.We are therefore proposing that we amend CHIP to allow the existing enforcing authorities (HSE and local authorities, including input from the Environment Agency) to also enforce the provisions of the CLP Regulation where these take over from CHIP in line with the transitional arrangements in the CLP Regulation.

27. In carrying over the existing enforcement arrangements to apply to the new provisions under CLP Regulation, we do not propose any change to the existing enforcement powers, penalties or sanctions.

Question 2 - Do you agree with the proposals to amend CHIP to allow the existing enforcement arrangements, including the same penalties and sanctions, to be used to enforce the provisions of the CLP Regulation?

Proposed Amendment 3 - implement Directive 2006/121/EC5

28.Directive 2006/121/EC is sometimes referred to as the ‘daughter’ Directive to the REACH Regulation (EC) No 1907/20066. It amends the Dangerous Substances Directive (67/548/EEC) in order to adapt it to the REACH Regulation.

29.The majority of the changes made by this Directive were implemented by the REACH Enforcement Regulations 2008 (SI 2008 No: 2852), which entered into force in the UK on 1 December 2008. We propose to amend an Administrative Provision of CHIP to implement the few minor changes that remain. These changes are not substantive – most

5 Directive 2006/121/EC can be found at:

http://eur-lex.europa.eu?LexUriServ/LexUriServ.do?uri=OJ:L:2006:396:0850:0856:EN:PDF6 Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation

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adjust the references to test methods following transfer from an Annex of REACH. This transfer and deletion of Annex V was effected by Annex V of the Dangerous Substances Directive in Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Nevertheless, the changes need to be given legal effect to ensure that the legal texts are coherent and consistent and that the UK fully implements Directive 2006/121/EC.

30.We propose amending the Approved Classification and Labelling Guide to accommodate these changes.

Question 3 - Do you agree that the remaining elements of Directive 2006/121/EC dealing with classification and labelling references are implemented through amendments to the Approved Classification and Labelling Guide?

Proposed Amendment 4 – inclusion of an ‘ambulatory reference’

31.The recent Legislative and Regulatory Reform Act 2006, allows Government to incorporate what is termed an ‘ambulatory reference’ in domestic legislation where it implements European law. An ‘ambulatory reference’ is merely a mechanism through which references to European law should be interpreted as referring to the latest version of that law, taking into account all relevant amendments. In practice, this means that fewer amendments will be needed to national law (where European law substantively alters legal duties and/or obligations, it is likely that domestic legislation would be amended too).

32.Technical and/or scientific updates to European law are usually referred to as Adaptations to Technical Progress, or ATPs. ATPs do not alter the main duties on suppliers but they update detailed requirements of the legislation in line with developing scientific and technical knowledge.

33.The implementation of ATPs will be familiar to chemical suppliers in GB. Under the current regime, it has been necessary to amend the CHIP regulations every 18 months to 2 years to give legal effect to changes agreed at EU level. A first amendment to the CLP Regulation is expected in June 2009 to incorporate changes that will be introduced in the 3rd revised edition of the GHS (the ‘Purple Book’), and to reflect changes in classifications and labels agreed as the 30th and 31st ATPs of the Dangerous Substances Directive.

34. In line with the existing regime, the CLP Regulation gives powers to the European Commission to “adjust and adapt” certain Articles and the supporting technical Annexes I to VII when scientific understanding and

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knowledge progresses, and as the GHS is amended. These changes will be achieved through ATPs.

35.We propose to include a new legal provision in CHIP 4, to allow for an ‘ambulatory reference’ which will allow CHIP 4 to refer to the latest version of the CLP Regulation and/or its supporting technical Annexes. This provision will avoid the need to constantly amend CHIP and will ensure that any enforcement action undertaken by the relevant enforcing authorities will refer to the latest version.

Question 4 - Do you agree with the proposed amendment to include an 'ambulatory reference' which will allow CHIP 4 to refer to the latest version of the CLP Regulation and/or its supporting technical Annexes?

Proposed Amendment 5 – discontinuation of the Approved Supply List

36.Currently, the Health and Safety Commission (now the Board of the HSE) publishes a national version of Annex 1 of the Dangerous Substances Directive, and subsequent ATPs, through the Approved Supply List (ASL). Annex 1 and the ASL list all the harmonised classifications and labelling requirements agreed at EU level. As the ASL sets out legally binding requirements each re-issue requires an amendment to the CHIP Regulations to give its contents legal effect in GB.

37.The ASL is only available in paper form. While many chemical suppliers found this useful, the existence of on-line, searchable chemical databases (including the forthcoming ECHA databases under the CLP Regulation), prompted us to consult on a proposal to stop publishing the ASL 7 The responses to consultation broadly confirmed this view. Furthermore, Annex VI of the new CLP Regulation presents a consolidated list of substances with their harmonised classifications and labels in both the existing EU system and in the GHS.

38.We propose to replace the references to the ASL in CHIP, with a reference to Annex VI of the CPL Regulation and authoritative chemical databases such as those maintained by the European Chemicals Agency.

Proposed Amendment 6 – changes to terminology

39.The CLP Regulation refers to “mixtures” rather than “preparations”.

7 The proposal to end the publication of the HSC’s Approved Supply List was set out in the

Consultative Document No 217: proposals for new amending Regulations about the Classification,

Packaging and Labelling of Chemicals: CHIP 3.2 The CD is available at:

http://www.hse.gov.uk/consult/condocs/cd217.htm

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40.We propose to include the term “mixtures” where necessary to ensure consistent terminology and clarification in the enforcement provisions.

Proposed Amendment 7 - minor editorial changes

41.There have been some recent changes to the legislation on medicines to separate out human medicines, clinical trials and veterinary medicines. For example, the Veterinary Medicines Regulations 2006 (as amended in 2007) change the Medicines Act 1968 so that it no longer includes veterinary medicines.

42.We propose to amend Regulation 3(3)(a) and (b) of CHIP to reflect these changes.

Question 5 – If you are a manufacturer, importer, formulator or distributor of chemicals, do the proposed changes to the CHIP Regulations cause you any specific problems?

Question 6 – If you are a person who works with chemicals (as an employee or self-employed person) do the proposed changes to the CHIP Regulations cause you any specific problems?

Scope of the proposed CHIP Regulations

43.As with previous CHIP Regulations, the proposed legal instrument will apply to Great Britain.

Competent Authority for the CLP Regulation

44.The CLP Regulation requires that each Member State set up a Competent Authority (CA) to perform certain administrative functions. The main role of the CA is that it can propose harmonised classifications for substances on behalf a Member State. The Competent Authority also has the right to request the information that a supplier has used to classify and label substances or mixtures that they have put on the market, and plays some minor administrative roles such as receiving information on whether requests for use of alternative chemical names have been granted.

45.The CLP Regulation also instructs Member States to establish a ‘Helpdesk’ to give advice to duty-holders and others on their obligations under the Regulation. The CA and Helpdesk do not have to be run by the same organisation, but given that they will require very similar expertise, it is assumed that, in practice, that they will be run together.

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46.The HSE currently undertakes these functions, although informally. It is expected that these arrangements continue under the CLP Regulation.

IMPACT ASSESSMENT

47.The impact on duty holders of provisions set out by the CLP Regulation was assessed in detail in consultation document No 213 (see http://www.hse.gov.uk/consult/condocs/cd213.htm The Impact Assessment for the proposed CHIP 4 Regulations does not address the costs and benefits assigned to provisions introduced by the CLP Regulation.

48.As the proposed CHIP Regulations apply existing enforcement arrangements, penalties and sanctions; do not extend the obligationson duty-holders; and seek to make administrative amendments to align domestic legislation with the CLP Regulation for the duration of the transitional periods, the cost implications of CHIP4 are negligible.

49.A short Impact Assessment appears at Appendix II.

Question 7 - Based on your experience, do you think that the assumptions made in the Impact Assessment are reasonable?

Question 8 - In your view how well does this consultation document explain the issue and proposed changes to the CHIP Regulations?

Question 9 - Is there anything you particularly liked or disliked about this consultation? Please comment if you wish.

INVITATION TO COMMENT

50.We would welcome your comments on these proposals. Please send your comments to Jan Harris by 13 February 2009 at the address below:

Jan HarrisInternational Chemicals UnitHealth and Safety Executive9th Floor South WingRose Court2 Southwark BridgeLondon. SE1 9HS

Tel: 020 7717 6251 Fax: 020 7717 6417


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51.For convenience, a response form is included at Appendix I. An electronic version is available at: http://www.hse.gov.uk/consult/condocs/You may find it helpful to use this form for your reply. We are happy to receive written comments in any form convenient to you. We will acknowledge receipt of all comments sent to us and will give them careful consideration.

52.The HSE would also like to know what you think of this consultation, both in terms of content and layout. Your views will help us to improve future consultations.

53. If you reply to this consultative document in a personal capacity, rather than as a post holder of an organisation, you should be aware that information you provide may constitute “personal data” in the terms of the Data Protection Act 1998. For the purposes of this Act, HSE is the “data controller” and will process the data for health and safety and environmental purposes. HSE may disclose these data to any person or organisation for purposes for which it was collected, or where the Act allows disclosure.

54.You have the right to ask for a copy of the data and to ask for inaccurate data to be corrected. Please note that all replies will be made public unless you specifically state that you wish yours to be made confidential.

55.Many business e-mail systems automatically append a paragraph stating that the message is confidential. If you are sending your comments by e-mail please state clearly if you are not content for your response to be made public.

What happens next?

56.We will give full consideration to the substance of arguments in all responses to the consultation.

Making responses public:

57.To make our consultation process as transparent as possible we make the comments we receive available to the public at our knowledge centre in Bootle, Merseyside. Copies will be made available at a small charge to cover costs, from the following address:

Knowledge CentreHealth and Safety Executive1G Redgrave CourtMerton RoadBootleMerseyside L20 7HS

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If you do not want your comments made publicly available please make this explicitly clear in your response.

Feedback, queries and complaints:

58.The Health and Safety Executive would also like to know what you think about the content and presentation of this consultation. Your views may help to improve other consultations. If you are not satisfied with the way in which this consultation exercise has been conducted we want to know, and we want to put things right. Please phone, or write to:

Robin FosterInternational Chemicals UnitHealth and Safety Executive9th Floor South WingRose Court2 Southwark BridgeLondon SE1 9HS

Tel: 020 7717 6990

59.We aim to reply to all complaints within 10 working days. If you are not satisfied with the outcome, you can raise the matter with the Chief Executive at the same address. You can also write to your MP to take up the case with us. Your MP may refer the matter to the Parliamentary Ombudsman who will investigate your complaint.

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APPENDIX I

Consultation on the proposed Chemicals (Hazard and Packaging for Supply) Regulations 2009 – CHIP 4

1. We would like you to tell us what you think about the proposals set out in this consultative document. We have asked a few questions, set out below, but we would welcome any additional views you may have. You may photocopy the response form below or tear it out and use. Please add extra sheets if you wish.

2. An electronic version of this response form is available at:http:// www.hse.gov.uk/consult/condocs/

3. You do not have to answer all the questions. But please answer as many as you can.

4. Please tick one box from the options below and then explain your answer in the space provided.

RESPONDENTS’ DETAILS

Title: First Name: Surname:

Organisation Name:

Address: Line 1:Line 2:Line 3:Town:County:Postcode:

Telephone: E-mail:

Q1 a. Do you currently classify, label and package chemical products (in other words, are you a chemical manufacturer, importer, supplier, distributor or retailer) or do you use chemicals in a professional capacity? (please tick all that apply)

I currently classify, label and package chemical productsI currently use chemical products in a professional capacityI do neither of the above

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Q 1 b. Type of organisation: (Industry, NGO, Trade Association, etc)

Q 1 c. Size of organisation:LargeMediumSmallMicro

Explanation:Large = over 250 Full Time Equivalent (FTE) employeesMedium = 50 – 249 FTE employeesSmall = 10 – 49 FTE employeesMicro = 0 – 9 FTE employees

Q 1 d. Which of the following best describes your sector type? (please tick all that apply)

Agriculture NGOBiocides PesticidesChemicals PlasticsCleaning PoliceConstruction PrintingEngineering QuarriesExplosives Professional userFire & rescue services RailwaysGas RecyclingHaulage/transport RefractoriesLaundries/dry cleaning Retail / wholesaleLocal government RubberManufacturing Surface engineeringMember of the public TextilesMining Trade AssociationNational Government Trade Union

Waste management

Other, please specify:

Q 1 e. – Confidentiality clause

I wish my response to remain confidential

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PROPOSED CHIP REGULATIONS (CHIP 4)

Please note: All views will be placed in HSE Information Centres unless you specifically state that this response, or a part of it, should be treated as confidential. All responses will be acknowledged.

Q1. Amendment 1 - Do you agree with the proposals to amend CHIP to allow compliance with the CLP Regulation (proposed Amendment 1)?

Agree Partly Agree

Don’t Agree Don’t know

Comments:

Q2. Amendment 2 - Do you agree with the proposals to amend Regulation 14 of CHIP to allow the existing enforcement arrangements, including the same penalties and sanctions, to be used to enforce the provisions of the CLP Regulation?

Agree Partly Agree


Comments:

Q3. Amendment 3 - Do you agree that the remaining elements of Directive 2006/121/EC dealing with classification and labelling references are implemented through amendments to the Approved Classification and Labelling Guide?

Agree Partly Agree


Comments:

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Q4. Amendment 4 - Do you agree with the proposed amendment to include an ‘ambulatory reference’ which will allow CHIP 4 to refer to the latest version of the CLP Regulation and/or its supporting technical Annexes? This provision will avoid the need to constantly amend CHIP and will ensure that any enforcement action undertaken by the relevant enforcing authorities will refer to the latest version.

Agree Partly Agree


Comments:

Q5. If you are a manufacturer, importer, formulator or distributor of chemicals, do the proposed changes to the CHIP Regulations cause you any specific problems?

Yes No Not Applicable

Don’t know

If there are problems, what are they:

Q6. If you are a person who works with chemicals (as an employee or self employed person) do the proposed changes to the CHIP Regulations cause you any specific problems?

Yes No Not Applicable

Don’t know

If there are problems, what are they:

IMPACT ASSESSMENT

Q7. Based on your experience, do you think that the assumptions made in the Impact Assessment are reasonable? If you do not agree, please provide sufficient detail to support your reasons.

Agree Partly Agree


Comments:

17

GENERAL

Q8. In your view how well does this consultation document explain the issue and proposed changes to the CHIP Regulations? (Please tick one box).

Very WellWellNot WellVery Poorly

Comment:

Q9. Is there anything you particularly liked or disliked about this consultation?

Please return your comments to Jan Harris by 13 February 2009 at the address below:

Jan HarrisInternational Chemicals UnitHealth and Safety Executive9th Floor South WingRose Court2 Southwark BridgeLondon. SE1 9HS

Tel: 020 7717 6251 Fax: 020 7717 6417


19

APPENDIX II

Short Impact Assessment for the proposed amendments to Chemicals (Hazard Information and Packaging for Supply) Regulations 2002

21

Summary: Intervention & Options

Department /Agency:


Title:

Impact Assessment of proposals to amend the Chemicals (Hazard Information and Packaging for Supply) Regulations 2002

Stage: Consultation Version: 1 Date: 7th November 2008

Related Publications:

Available to view or download at:

http://www..hse.gov.uk/consult/

Contact for enquiries: Jan Harris or Pierre Cruse Telephone: 0207717 6251/ 6122

What is the problem under consideration? Why is government intervention necessary?

The new European Regulation on the Classification, Labelling and Packaging of Substances and Mixtures - CLP Regulation - is directly acting on all EU Member States. However, Member States, including the UK must implement the necessary enforcement provisions. It is proposed to achieve this through an amendment to the CHIP regulations. The regulations will also align domestic legislation with the CLP Regulation during the transitional period, until such time as the CLP Regulation replaces it in 2015.

What are the policy objectives and the intended effects?

To assist duty holders in preparing for the new European Regulation by amending domestic legislation: to reflect the transitional period; to implement the necessary enforcement provisions; and to allow duty holders to comply with the CLP Regulation before the mandatory compliance dates should they choose to for business reasons.

What policy options have been considered? Please justify any preferred option.

The UK is obliged to implement the changes described above under CLP Regulation, and failure to do so would create incoherent and inconsistent legal requirements and leave the UK open to infraction. Amending the existing CHIP regulations, which currently implement existing European legislation on classification and labelling of chemicals, provides an established and well understood legal framework in which to fulfil these obligations. Options to the CLP Regulation itself were fully considered in the RIA to that Regulation.

When will the policy be reviewed to establish the actual costs and benefits and the achievement of the desired effects? The costs and benefits of the policy will be reviewed in considering the outcomes of formal public consultation on the proposed amendments to CHIP.

Ministerial Sign-off For consultation stage Impact Assessments:

I have read the Impact Assessment and I am satisfied that, given the available evidence, it represents a reasonable view of the likely costs, benefits and impact of the leading options.

Signed by the responsible Minister:

.............................................................................................................Date:

22

Summary: Analysis & Evidence

Policy Option: Description:

ANNUAL COSTS

One-off (Transition) Yrs

£ 0

Average Annual Cost (excluding one-off)

Description and scale of key monetised costs by ‘mainaffected groups’

£ 0 Total Cost (PV) £ 0CO

ST

S

Other key non-monetised costs by ‘main affected groups’

ANNUAL BENEFITS

One-off Yrs

£ 0 0

Average Annual Benefit (excluding one-off)

Description and scale of key monetised benefits by ‘mainaffected groups’ 0

£ 0 Total Benefit (PV) £ 0BE

NE

FIT

S

Other key non-monetised benefits by ‘main affected groups’ Ensures that CHIP is consistent with the CLP Regulation, and therefore provides clarity to all affected groups that CLP's transitional arrangements can be properly implemented and that it can be enforced.

Key Assumptions/Sensitivities/Risks Assumed that CHIP 4 will enable compliance with and enforcement of CLP Regulation. Assumed that editorial changes to CHIP 4 (e.g. updating references to other legislation) will not affect scope. Assumed that cost of enforcement and transitional arrangements fully considered in IA to CLP Regulation.

Price Base Year 0

Time Period Years 0

Net Benefit Range (NPV)

£ 0NET BENEFIT (NPV Best estimate)

£ 0

What is the geographic coverage of the policy/option? Great Britain

On what date will the policy be implemented? 6 April 2009

Which organisation(s) will enforce the policy? HSE, LAs, EA, SEPA,

What is the total annual cost of enforcement for these organisations? £ N/A

Does enforcement comply with Hampton principles? Yes

Will implementation go beyond minimum EU requirements? No

What is the value of the proposed offsetting measure per year? £ 0

What is the value of changes in greenhouse gas emissions? £ 0

Will the proposal have a significant impact on competition? No

Annual cost (£-£) per organisation (excluding one-off)

Micro0

Small0

Medium0

Large0

Are any of these organisations exempt? No No N/A N/A

Impact on Admin Burdens Baseline (2005 Prices) (Increase - Decrease)

Increase of £ 0 Decrease of £ 0 Net Impact £ 0

Key: Annual costs and benefits: Constant Prices (Net) Present Value

Evidence Base (for summary sheets)

[Use this space (with a recommended maximum of 30 pages) to set out the evidence, analysis and detailed narrative from which you have generated your policy options or proposal. Ensure that the information is organised in such a way as to explain clearly the summary information on the preceding pages of this form.]

1. The European Regulation on the Classification, Labelling and Packaging of Substance and Mixtures (CLP Regulation) adopts in EU Member States the criteria set out in the UN agreement on the Globally Harmonized System on the Classification and Labelling of chemicals. The CLP Regulation is expected to be adopted in late 2008/ early 2009, though it will only become fully mandatory for substances after 1st December 2010 and mixtures after 1st June 2015.

2. The CLP Regulation will act directly in all Member States. However it is necessary to produce national enforcing regulations and to make various further amendments to national legislation (CHIP regulations) to align with the changes at European level.

3. The required amendments to the CHIP regulations are:

Amendments to CHIP to enable compliance with the CLP Regulation in line with the EU Regulation’s transitional arrangements

Enforcement provisions

Implementation of the outstanding provisions of Directive 121/2006/EC

Discontinuation of the GB Approved Supply list

Two minor editorial changes

The amended version of CHIP will be known as CHIP 4.

4. The sectors affected by this regulation are the same as those which are affected by the CLP Regulation itself. The Impact Assessment for the CLP Regulation identified six main affected groups: chemical manufacturers; downstream businesses; wholesalers; retailers; the public authorities; and retail consumers of chemical products.

5. The new regulation will make technical amendments to existing legislation to enable national law to align with European CLP Regulation. It introduces no significant new duties beyond those introduced by the CLP Regulation itself.

6. A full Regulatory Impact Assessment (RIA) was conducted for the CLP Regulation, in which the costs and benefits of the Regulation were considered. Although the proposed amendments to CHIP will contribute to the realisation of the CLP Regulation’s costs and benefits, e.g. through national enforcing provisions, those costs and benefits are properly attributable to the CLP Regulation and it is not appropriate to further assess them in relation to this regulation.

Costs and benefits - costs

7. Costs associated with each element of the CLP Regulation are considered separately.

Amendments to CHIP to enable compliance with the CLP Regulation

8. Currently in the UK chemical classification, labelling and packaging legislation applies the requirements of the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC), through the Chemical Hazard Information, Packaging and Supply (CHIP) Regulations. The CLP Regulation will introduce requirements for chemical

23

24

classification, labelling and packaging broadly similar to those of CHIP, though there are some differences of detail. These new requirements will enter into force over a transitional period, and will ultimately replace the CHIP requirements altogether.

9. The specific transitional arrangements which will have to be taken into account are as follows:

Substances

Entry into force (late 2008/early 2009) – 1st

December 2010

Suppliers must classify substances according to CHIP, and may continue to label them according to CHIP.However they may classify according to CLP in addition to CHIP, in which case they must label and package according to CLP.

1st December 2010 – 1st June 2015

Suppliers must classify substances according to both CHIP and CLP. They must label according to CLP.


Suppliers must classify and label according to CLP

Mixtures

Entry into force (late 2008/early 2009) – 1st June 2015

Suppliers must classify mixtures according to CHIP, and may continue to label them according to CHIP. However they may classify according to CLP in addition to CHIP, in which case they must label and package according to CLP.


Suppliers must classify and label according to CLP.

10. Amendments to CHIP are required to ensure that it remains consistent with the above transitional arrangements. First, CHIP needs to be amended so that it also allows substances and mixtures to be classified, labelled and packaged in accordance with CLP during the transitional periods, as an alternative to the classification arrangements it specifies itself. This will be accomplished by including in CHIP a derogation allowing compliance with CLP from its date of entry into force until the end of the transitional periods. Second, a provision needs be included in CHIP to disapply it completely once CLP is mandatory from 1st June 2015 (except for the provisions for enforcing CLP).

11. It is not expected that the required amendments to CHIP have any cost implications.Amendments to CHIP are being introduced only to ensure legal consistency when the CLP Regulation is introduced. They are not in themselves the source of the transitional arrangements or of any other duties on suppliers. All costs of reclassifying and relabelling have already been taken into account in the RIA to the CLP Regulation itself, as well as costs due to the transitional arrangements1, so it would be double counting to attribute any such costs to the amendments to CHIP. No further costs in addition to these are envisaged.


12. Amendments to CHIP will include provisions to enforce all relevant requirements under the CLP Regulation. It is expected that existing enforcement provisions will be carried over from CHIP, together with provisions to enforce any new offences under CLP. As the scope of the

1 See UK final Regulatory Impact Assessment (after consultation) on the proposed European Regulation on the Classification,

Labelling and Packaging of Substances and Mixtures (based on the UN Globally Harmonised System – GHS), sections 5.11-

5.16.

25

Evidence Base (for summary sheets)

[Use this space (with a recommended maximum of 30 pages) to set out the evidence, analysis and detailed narrative from which you have generated your policy options or proposal. Ensure that the information is organised in such a way as to explain clearly the summary information on the preceding pages of this form.]

1. The European Regulation on the Classification, Labelling and Packaging of Substance and Mixtures (CLP Regulation) adopts in EU Member States the criteria set out in the UN agreement on the Globally Harmonized System on the Classification and Labelling of chemicals. The CLP Regulation is expected to be adopted in late 2008/ early 2009, though it will only become fully mandatory for substances after 1st December 2010 and mixtures after 1st June 2015.

2. The CLP Regulation will act directly in all Member States. However it is necessary to produce national enforcing regulations and to make various further amendments to national legislation (CHIP regulations) to align with the changes at European level.

3. The required amendments to the CHIP regulations are:

Amendments to CHIP to enable compliance with the CLP Regulation in line with the EU Regulation’s transitional arrangements


Implementation of the outstanding provisions of Directive 121/2006/EC

Discontinuation of the GB Approved Supply list

Two minor editorial changes

The amended version of CHIP will be known as CHIP 4.

4. The sectors affected by this regulation are the same as those which are affected by the CLP Regulation itself. The Impact Assessment for the CLP Regulation identified six main affected groups: chemical manufacturers; downstream businesses; wholesalers; retailers; the public authorities; and retail consumers of chemical products.

5. The new regulation will make technical amendments to existing legislation to enable national law to align with European CLP Regulation. It introduces no significant new duties beyond those introduced by the CLP Regulation itself.

6. A full Regulatory Impact Assessment (RIA) was conducted for the CLP Regulation, in which the costs and benefits of the Regulation were considered. Although the proposed amendments to CHIP will contribute to the realisation of the CLP Regulation’s costs and benefits, e.g. through national enforcing provisions, those costs and benefits are properly attributable to the CLP Regulation and it is not appropriate to further assess them in relation to this regulation.

Costs and benefits - costs

7. Costs associated with each element of the CLP Regulation are considered separately.


8. Currently in the UK chemical classification, labelling and packaging legislation applies the requirements of the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC), through the Chemical Hazard Information, Packaging and Supply (CHIP) Regulations. The CLP Regulation will introduce requirements for chemical

26

finding the classifications of the substances they supply. It is assumed that larger companies which supply a significant number of different chemicals are likely to have internet access. If only a small number of substances are supplied, information about harmonized classifications could be obtained in a number of ways, for example by seeking public internet access facilities or by phoning HSE or the Competent Authority.

20. It seems reasonable to assume that the costs of such additional time will be relatively small in relation to the total cost savings to business detailed above. To give an indicative figure, if 25% of current customers for the ASL are required to spend an additional 2 hours seeking substance classifications compared with using the ASL this would give a cost of £74,696, assuming the average cost for an employee’s time is £20.72.4

21. In summary, the cost implications of discontinuing the ASL are expected to be minor, and any costs are likely to be compensated by corresponding benefits from not having to purchase the ASL. Moreover, the uncertainties of estimating the net cost are large. Therefore, the best overall estimate is that the removal of the ASL will be on balance cost neutral.

Updating references to British and International standards for child resistant fastenings

22. Regulation 11 and Schedule 6 of CHIP refer to several British and International Standards relating to child resistant closures and packaging, and tactile warnings of danger. These standards have either been updated or renamed since the latest version of CHIP was introduced, and stakeholders have requested that HSE update CHIP accordingly. Previously it has not been possible to make these amendments since the origin of these measures (Article 22 and Annex IX of the Dangerous Substances Directive) does not make available to Member States the facility to update to the latest standards. However, since the CLP Regulation includes reference to the new standards, it is proposed at this stage to update the references in CHIP to the new standards.

23. It is not expected that updating the reference to child resistant fastenings will have significant cost implications. The change will not introduce new standards, but will merely ensure that references are up to date, and in any case manufacturers are already to a large extent complying with the most recent standards. Moreover, once CLP is introduced, the new standards will become mandatory by 1st December 2010 for substances and 1st June 2015 for mixtures. There may be costs in applying the updated standards in advance of these dates for those companies not already doing so, but this is not expected to be large. In summary, this amendment is primarily administrative and we have no evidence that it will have significant costs for business.

Updating reference to Medicines Act 1968

24. CHIP currently contains certain exemptions for substances and preparations which are defined within other legislation. One such exemption is for medicinal products within the meaning of section 130 of the Medicines Act 1968.

25. However there have been some recent changes to the legislation to separate out Human Medicines, clinical trials and veterinary medicines. As a result of these changes, the Medicines Act 1968 has been replaced by several pieces of other legislation. The CHIP Regulations will update references to the legislation replacing the Medicines Act 1968 to ensure it is up to date.

26. The purpose of these amendments is to ensure that references to other legislation in defining the scope of CHIP is up-to-date, and are not expected to modify the scope of CHIP in any way. Therefore, the amendments are expected to be cost-neutral.

4 This is based on the mean average wage for all employees in SIC 24 of £15.94 from the Annual Survey of Hours and

Earnings (ASHE) 2006 (Office of National Statistics). Costs are multiplied by 1.3 to include non-wage employment costs.

27

Further general cost considerations

27. Familiarisation costs. It is not expected that there will be any significant familiarisation costs for industry associated with this regulation. The legislation concerns legal amendments to ensure that the CLP Regulation can be enforced and implemented. It does not impose any new duties or significantly alter existing duties and the enforcing authorities remain the same. Therefore it should not be necessary for dutyholders to familiarize themselves with the detail of the regulation. It may be necessary for some suppliers to familiarise themselves with specific details within the regulation, such as the updated standards for child resistant closures, but this is not likely to impose significant costs. To be able to fully comply with the CLP regulation, including its transitional provisions, it is primarily necessary that duty holders familiarise themselves with the CLP Regulation itself, but this has been fully costed in the RIA to that Regulation.

Benefits

28. The chief benefit of this regulation is that it will provide legal certainty and administrative clarity that the CLP Regulation can be enforced and implemented, and its benefits realised. As such it can be seen as contributing to the overall benefits of the CLP Regulation. However the benefits of the CLP Regulation itself have been fully considered in the RIA to that Regulation, therefore to avoid double counting it is not appropriate to provide additional cost estimates for these benefits in relation to this regulation.

29. In addition to the above there may be a small benefits to businesses as a result of the information on harmonized classification becoming available over the internet rather than through purchasing the Approved Supply List, and as a result of clarifying and making fully consistent the requirements on child resistant closures. However, such benefits are likely to be of very minor significance.

Summary of costs and benefits

30. The only elements of this regulation for which potential costs or benefits have been identified are the removal of the Approved Supply List and updating the references to standards for child resistant fastenings. However the costs or benefits involved are likely to be extremely small, and the uncertainties involved in estimating them large. Moreover it is estimated that the potential small costs are likely on balance to be compensated by corresponding benefits.Therefore, the overall assessment of the impact of CHIP 4 is that it will be cost-neutral.

Small firms impact test

31. Four relevant trade associations who cover both chemical-related businesses and small businesses in general, were asked to provide the names of small firms who would be willing to participate in an initial impact study for CHIP 4. The names of 8 businesses were obtained who were willing to participate.

32. Each participating firm was asked the following questions relating to the impact of the regulation.

Q1: Do you agree that the above amendments to CHIP, to be made in CHIP 4, have no cost implications? (Question refers to implementation of Directive 121/2006, amendments to CHIP to enable early compliance with CLP Regulation, and Enforcement provisions).

Q2: Previous consultation has indicated that we should not assume that all businesses who will need to classify chemicals will have internet access. Are you aware of any

28

relevant businesses which do not have internet access? If you are, how do such businesses access information on the internet?

Q3: Do you agree that the cost implications for businesses of replacing the ASL with an internet database are likely to be negligible?

Q4: are we right to assume that manufacturers are currently complying with the latest standards for child resistant fastenings (etc.)? If not, what would be the cost implication to a business of complying with the latest standards?

Q5: Are you aware of any other potential cost implications for businesses associated with the changes involved in CHIP 4 which have not been mentioned above?

33. Of the 8 businesses contacted, responses were received from 5. Respondents generally agreed that the amendments referred to in Question 1 would have no cost implications. One of the five respondents suggested that they would require a small amount of time to review the new provisions to ensure compliance. However, given that the provisions in question impose no new duties on suppliers beyond those of the CLP Regulation, this has not been included as a cost attributable to CHIP 4, since businesses do not need to do this to comply with CHIP 4 (see para. 24).

34. In relation to questions 2 and 3, respondents indicated that they were unaware of any businesses without internet access, and thought it unlikely that there were many such businesses. All respondents agreed that the replacement of the Approved Supply List would not impose any significant costs, and one welcomed it as a potentially time saving improvement. One respondent stated that they used software containing a database of harmonised classifications rather than the Approved Supply List. This software incurs an annual maintenance charge of £2698, however no reason was given why this should change if the ASL is replaced by an internet database, so this has not been included here as a cost.

35. Respondents were generally unaware of whether businesses were generally complying with the latest standards for child-resistant fastenings. Only one used such fastenings themselves, and stated that they would need to confirm compliance with the latest standards with the manufacturer. If changes were required, they would also have to carry out quality testing and change to specifications, process records and instructions. However they thought the cost in doing this would be ‘probably minimal’.

36. No further costs were identified. One respondent was concerned that there may be a cost for re-issuing on site COSHH data, and of having to reclassify chemicals and revising their Health and Safety policies as a result of the new regulation. However, such costs if incurred would be attributable to the CLP Regulation rather than CHIP 4, so these have not been included here.

Competition assessment

37. The proposed regulation is not expected to have a significant impact on competition. The reasons for this are summarised briefly in relation to each element of the regulation below.


38. The amendments are being made to render CHIP consistent with the transitional arrangements in the CLP Regulation. The RIA for the CLP Regulation itself identified that transition to GHS would lead to greater costs for some businesses than some others, and could in the worst case cause some suppliers to exit their respective market as a result of these transitional costs, although no specific evidence was obtained that this would take place.

39. However, any effects of the transitional arrangements on competition would be attributable to the CLP Regulation and not the amendments to CHIP. Furthermore, no additional effects

29

have been identified on competition beyond those of the transitional arrangements. Therefore, the amendments to CHIP are not expected to have any impact on competition.


40. Effects of the enforcement provisions have been fully considered in the RIA for the CLP Regulation, so are not further considered in relation to this regulation. In any case, no impacts on competition have been identified.

Implementation of Directive 121/2006

41. The amendments are routine and editorial and are expected to have no effect on competition.

Discontinuation of the GB Approved supply list

42. The removal of the ASL may impose very slightly greater costs on suppliers who do not have internet access in relation to those that do, in relation to looking up harmonised substance classifications. However, these costs are not expected to be significant, for reasons explained above (see paras. 16-21). As a result, no significant impact on competition is expected as a result of these changes.

Updating references to standards for child resistant fastenings

43. There may be a small, short term impact on competition if some manufacturers incur extra one-off costs as a result of having to conform to updated standards on child-resistant fastenings (though most manufacturers are already applying the up-to-date standards). However, updating the standard will ultimately assist competition, by ensuring legal clarity about the standards to be applied and setting a level playing field for manufacturers. Therefore, the net impact of these amendments on competition is expected to be positive rather than negative.

44. In general is also worth noting that one of the aims of the GHS system is to remove trade barriers which arise from having several systems worldwide for classifying and labelling chemicals. By introducing the GHS system in the EU the CLP Regulation may therefore assist global competition, though the extent of this is uncertain and depends on the extent to which other countries and jurisdictions also introduce GHS. To the extent that CLP does enhance competition in this way, this can in part be attributable to the amendments to CHIP, however as with other benefits this is impossible to quantify meaningfully.

Updating reference to Medicines Act 1968

45. The amendments to the Medicines Act are purely editorial and designed to ensure that references to the relevant legislation are up-to-date. They are not expected to have an impact on competition.

30

Specific Impact Tests: Checklist

Use the table below to demonstrate how broadly you have considered the potential impacts of your policy options.

Ensure that the results of any tests that impact on the cost-benefit analysis are contained within the main evidence base; other results may be annexed.

Type of testing undertaken Results in Evidence Base?

Resultsannexed?

Competition Assessment Yes No

Small Firms Impact Test Yes No

Legal Aid No No

Sustainable Development No No

Carbon Assessment No No

Other Environment No No

Health Impact Assessment No No

Race Equality No No

Disability Equality No No

Gender Equality No No

Human Rights No No

Rural Proofing No No

31

APPENDIX III

LIST OF ORGANISATIONS & INDIVIDUALS CONSULTED

Government Departments

Cabinet Office – European SecretariatCabinet Office – Office of Public ServiceCentral Office of InformationCrown Estate CommissionersDepartment of Agriculture and Rural Development – Northern IrelandDepartment for Communities and Local GovernmentDepartment for Constitutional AffairsDepartment for Education and SkillsDepartment for Environment, Food and Rural Affairs

Chemicals and GM Policy DivisionGlobal Atmosphere DivisionPesticides Safety DirectorateWaste Management DivisionWater Quality Division

Department of HealthDepartment for Business, Enterprise and Regulatory ReformDepartment for Business, Enterprise and Regulatory Reform –

Enterprise DirectorateDepartment for TransportDepartment for Work and Pensions – Workplace Health DivisionForeign and Commonwealth OfficeHealth and Safety Agency for Northern IrelandHealth Protection AgencyHM Prison ServiceHM Revenue and Customs HM TreasuryHome OfficeLaw Officers’ DepartmentsMinistry of DefenceNational Assembly for WalesNorthern Ireland Department of Enterprise, Trade and InvestmentNorthern Ireland OfficeScottish GovernmentScottish Government’s Environmental Quality DirectorateScottish Government’s Healthcare Planning and Strategy Directorate

Public Bodies

British Broadcasting CorporationCivil Aviation AuthorityCountryside AgencyEnvironment AgencyForestry Commission

32

Historic Royal Palaces AgencyHouse of Commons LibraryHouse of Lords LibraryJoint Nature Conservation CommitteeLaboratory of the Government ChemistLaw CommissionMaritime and Coastguard AgencyNational Consumer CouncilOffice for National StatisticsScottish Environment Protection AgencyScottish Law Commission

European Union, Crown Dependencies and Overseas Territories

Government of Gibraltar – Ministry of EmploymentHealth and Safety Authority – Republic of IrelandHealth and Safety Executive, GuernseyDepartment of Local Government and the Environment, Isle of Man Department of Employment and Social Security, JerseyUK Permanent Representation to the European Union

Local Government Organisations

Association of London GovernmentConvention of Scottish Local AuthoritiesLACORSLocal Government AssociationNational Association of Local CouncilsNorthern Ireland Local Government Association

Employers’ Organisations and Small Firms’ Representatives

Alliance of Independent RetailersBritish Association of EntrepreneursBritish Chambers of Commerce Building Employers FederationConfederation of British IndustryCBI – Smaller Firms CouncilElectrical Contractors AssociationEngineering Employers’ FederationEuropean Association of Craft, Small and Medium-Sized Enterprises (UEAPME) Federation of Small BusinessesInstitute of DirectorsUniversities and Colleges Employers’ Association

Trade Unions and Employee Organisations

AmicusAssociation of Teachers and Lecturers

33

Bakers, Food and Allied Workers UnionBALPABECTUBritish Medical AssociationCommunications Workers UnionFire Brigades UnionFire Officers AssociationGeneral Federation of Trade UnionsGMBNATFHENational Association of Colliery Overmen, Deputies and ShotfirersNational Union of Domestic Appliances and General OperativesNUMASTPolice Federation of England and WalesProspectRoyal College of NursingScottish Police FederationScottish Trades Union CongressSociety of RadiographersTrades Union CongressTransport and General Workers UnionUCATTUNISONUSDAW

Trade Associations and Learned Bodies

Adhesive Tape Manufacturers AssociationAgricultural Engineers AssociationAgricultural Industries ConfederationAssociation of British Mining Equipment CompaniesAssociation of the British Pharmaceutical IndustryAssociation of Light Alloy Refiners LtdBrick Development AssociationBritish Adhesives and Sealants AssociationBritish Aerosol Manufacturers AssociationBritish Agrochemicals AssociationBritish Apparel and Textile ConfederationBritish Association for Chemical SpecialtiesBritish Battery Manufacturers AssociationBritish Ceramic ConfederationBritish Chemical Distributors and Traders AssociationBritish Coatings Federation British Colour Makers AssociationBritish Contract Furnishing AssociationBritish Electrotechnical and Allied Manufacturers AssociationBritish Fluid Power AssociationBritish Footwear AssociationBritish Fragrance AssociationBritish Furniture Manufacturers Association

34

British GlassBritish Institute of Professional Photography British Jewellers’ Association British Leather ConfederationBritish Metals Recycling AssociationBritish Non-Ferrous Metals FederationBritish Pest Control AssociationBritish Plastics FederationBritish Printing Industries FederationBritish Pump Manufacturers AssociationBritish Pyrotechnists AssociationBritish Retail ConsortiumBritish Rigid Urethane Foam Manufacturers AssociationBritish Rubber Manufacturers AssociationBritish Surface Treatment Suppliers Association British Textile Technology GroupBritish Veterinary AssociationBritish Wood Preserving and Damp Proofing AssociationBuilding Employers ConfederationCastings Development CentreCast Metals FederationChemical Industries AssociationCivil Engineering Contractors AssociationComposites Processing Association Confederation of British Wool TextilesConstruction Industry Research and Information AssociationConstruction Products AssociationCosmetics, Toiletries and Perfumeries AssociationCrop Protection AssociationDairy Industry Federation Defence Manufacturers AssociationDigital and Screen Printing AssociationEnergy InstituteEngineering Industries Association European Process Safety CentreExplosive Industry Group - CBIFarmers Union of WalesFertiliser Manufacturers AssociationFood and Drink FederationFreight Transport AssociationFriends of PyrethrumGlass and Glazing FederationGrain and Feed Trade AssociationHorticultural Trades AssociationInstitute of Metal Finishing Institution of Chemical EngineersInstitution of Electrical EngineersIntellectLaw Society of England and WalesLaw Society of Scotland

35

National Farmers Union National Farmers Union of ScotlandNational Federation of Demolition ContractorsNational Specialist Contractors CouncilOffshore Contractors AssociationPaint Research AssociationPainting and Decorating AssociationPaper Federation of Great BritainPlastics and Board Industries FederationQuarry Products AssociationResin Flooring Association Road Haulage AssociationRoyal Agricultural Society of EnglandRoyal Highland and Agricultural Society of ScotlandRoyal Pharmaceutical Society of Great BritainThe Royal SocietyRoyal Society of ChemistryScotch Whisky AssociationScottish Food and Drink FederationScottish Pharmaceutical FederationShipbuilders and Ship repairers AssociationSociety of British Aerospace CompaniesSociety of British Gas IndustriesSociety of Chemical IndustrySociety of Dyers and ColouristsSociety of Motor Manufacturers and TradersSolvents Industry AssociationSurface Engineering AssociationTank Storage AssociationTextile Services AssociationTile AssociationTimber Trade AssociationUK Cleaning Products Industry AssociationUnited Kingdom Lubricants AssociationWater UKWelding Manufacturers Association

Police and Emergency Services Bodies

Association of Chief Police Officers of England, Wales and Northern IrelandAssociation of Chief Police Officers in ScotlandChief Fire Officers’ Association

Health and Safety Specialists

Association of Port Health AuthoritiesBiotechnology and Biological Sciences Research CouncilBritish Institute of Occupational HygieneBritish Occupational Hygiene Society

36

British Safety CouncilChartered Institute of Environmental Health OfficersInstitute of Occupational MedicineInstitution of Occupational Safety and HealthNatural Environment Research CouncilNewcastle Occupational HealthRoyal Environmental Health Institute of ScotlandRoyal Society for the Prevention of AccidentsSociety/Faculty of Occupational Medicine

Academic Institutions

Institute of Cancer ResearchUniversity of Birmingham – Institute of Occupational and Environmental MedicineUniversity of Manchester – Centre for Occupational and Environmental Health

Other Organisations

Cancer Research UKThe Consumers Association The Environment Council

Individual Companies

Adshead Ratcliffe and Company LtdAgropharm LtdAirbus UK LtdAkcros ChemicalsAlcohols LtdAllied Glass ContainersArkema LtdAtofina UK LtdAvon Rubber plcB&QBAE SystemsBASF plc Industrial ChemicalsBayer UK LtdBecker Acroma LtdBritannia Refined Metals LtdCaswell AdhesivesChemtek Ltd Ciba Specialty ChemicalsClariant UK LtdContract ChemicalsDexter Paints LtdDomino UK LtdDunlop Aircraft Tyres LtdElementis Chromium

37

Ellis and Everard (Chemicals) plcEnersysFenner DunlopFour D Rubber Co LtdHickson and Welch LtdHome Retail Group PlcHoneywill and Stein LtdHornett Bros and Co LtdHuntsman European ChemicalsIneos Chlor LtdInternational Paint LtdKingspan LtdKingspan Insulation LtdLuminescenceMallinckrodt Chemical LtdMorris LubricantsL’Oreal Manufacturing (UK) Ltd PDM Neptec LtdPerstorp LtdPetrochem CarlessPirelli UK Tyres LtdPolyflor LtdRhodia UK LtdSafic-Alcan UK LtdSaudi Basic Industries CorporationSGS Vernolab LtdSigma Aldrich Co LtdSolutia UK LtdSpray Nine Europe LtdSun Chemical LtdTennants Distribution LtdWickes Building Supplies LtdWincantonWitham Oil and Paint (Lowestoft) LtdWhyte Chemicals Group

39

S T A T U T O R Y I N S T R U M E N T S

2009 No.

HEALTH AND SAFETY

The Chemicals (Hazard Information and Packaging for Supply)

Regulations 2009

Made - - - - ***

Laid before Parliament ***

Coming into force - - ***

The Secretary of State is a Minister designated for the purpose of section 2(2) of the European

Communities Act 1972(a) (“the 1972 Act”) in relation to the regulation and control of

classification, packaging and labelling of dangerous substances and preparations(b), and for

measures relating to consumer protection(c).

The Secretary of State makes these Regulations:

(a) in exercise of the powers conferred upon him by section 2(2) of the 1972 Act and by section

15(1), (2), (3)(c), (4)(b), (6)(b), (8) and (9) and 82(3)(a) of, and paragraphs 1(1)(b) and (c), (4) and

(5), 2(1), 3(2), 15(1) and 16 of Schedule 3 to, the Health and Safety at Work etc. Act 1974(d); and

(b) for the purpose of giving effect without modifications to proposals submitted to him by the

Health and Safety Executive under section 11(3)(e) of the 1974 Act after the carrying out by the

said Executive of consultations in accordance with section 50(3) of that Act.

These Regulations make provision for a purpose mentioned in section 2(2) of the 1972 Act and it

appears to the Secretary of State that it is expedient for references in these Regulations to the

Regulation (EC) No XXX/2008 of the European Parliament and of the Council of XX XXX 2008

on the classification, labelling and packaging of substances and mixtures, amending and repealing

Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006(f) to be

construed as including references to articles 6(5), 11(3), 12, 14, 18(3)(b), 25, 27-31(2) and

Annexes I to VII of that Regulation as amended from time to time.

(a) 1972 c.68. The power of the Minister to make regulations in relation to matters in or as regards Scotland is preserved by section 57(1) of the Scotland Act 1998 (c.46).

(b) S.I. 1976/897.(c) S.I. 1993/2661.

(d) 1974 c.37, as amended by S.I. 2008/960. Section 1(1)(c) was modified by the Health and Safety at Work etc. Act (Application to Environmentally Dangerous Substances) Regulations 2002, S.I. 2002/282. There are other amending

instruments but none is relevant.(e) Section 11(3) is substituted by S.I. 2008/960.

(f) XXXX

40

PART 1

INTRODUCTION

Citation, commencement and extent

1.—(1) These Regulations may be cited as the Chemicals (Hazard Information and Packaging

for Supply) Regulations 2009 and shall come into force on 6th

April 2009.

(2) These Regulations shall not extend to Northern Ireland.

Interpretation

2.—(1) In these Regulations—

“The 1974 Act” means the Health and Safety at Work etc. Act 1974;

“aerosol dispenser” means an article which consists of a non-reusable receptacle containing a

gas compressed, liquefied or dissolved under pressure, with or without liquid, paste or powder

and fitted with a release device allowing the contents to be ejected as solid or liquid particles

in suspension in a gas, as a foam, paste or powder or in a liquid state;

“the approved classification and labelling guide” means the guide entitled “Approved Guide to

the Classification and Labelling of Dangerous Substances and Dangerous preparations (Fifth

Edition)” approved by the Health and Safety Commission on 16th

April 2002(a), as revised or

re-issued from time to time;

“category of danger” means, in relation to a dangerous substance or dangerous preparation,

one of the categories of danger specified in column 1 of Schedule 1;

“the CLP Regulation” means Regulation (EC) No XXX/2008 of the European Parliament and

of the Council of XX XXX 2008 on the classification, labelling and packaging of substances

and preparations, amending and repealing Directives 67/548/EEC and 1999/45/EC, and

amending Regulation (EC) No 1907/2006, of which articles 6(5), 11(3), 12, 14, 18(3)(b), 25,

27-31(2) and Annexes I to VII are as amended from time to time;

“Community workplace exposure limit” means, in respect of a substance, an exposure limit

for that substance established in a Community instrument;

“competent authority” has the same meaning it has in the CLP Regulation and in respect of

Great Britain the authorities are—

(a) in England, the Secretary of State;

(b) in Scotland, the Scottish Ministers;

(c) in Wales, the Welsh Ministers, and

(d) in relation to matters outside the competence of a devolved administration, the Secretary

of State(b);

“dangerous preparation” means a preparation which is in one or of the categories of danger

specified in column 1 of Schedule 1;

“dangerous substance” means a substance—

(a) which is listed in Table 3.2 part 3 of Annex VI of the CLP Regulation; or

(b) if it is not so listed, which is in one or more of the categories of danger specified in

column 1 of Schedule 1;

“devolved administration” means the Scottish Ministers or the Welsh Ministers;

“EC number” means—

(a) ISBN 0717623696(b) The appointment of the competent authorities has been made under SI 2009/XXXX. By administrative arrangements the

competent authorities have delegated the Health and Safety Executive to act on their behalf.

41

(a) in the case of a dangerous substance that appears in Table 3.2. part 3 of Annex VI of

the CLP Regulation, the EC number specified in that list;

(b) in the case of a dangerous substance that is not included in Table 3.2, part 3 of

Annex VI of the CLP Regulation or for which an EC number is not given in that

list, the number for that substance specified in EINECS; or

(c) in the case of a dangerous substance that is not a phase-in substance within the

meaning of REACH, the number for that substance if it is listed in ELINCS;

“EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on

2nd

May 1992, as adjusted by the Protocol signed at Brussels on 17th

March 1993 and adopted

as respects the United Kingdom by the European Economic Area Act 1993(a);

“EEA State” means a state which is a contracting party to the EEA Agreement;

“EINECS” means the European Inventory of Existing Commercial Chemical Substances;

“ELINCS” means the European List of Notified Chemical Substances;

“enforcing authority” shall be construed in accordance with regulation 14;

“the Executive” means the Health and Safety Executive;

“indication of danger” means, in relation to a dangerous substance or dangerous preparation,

one or more of the indications of danger referred to in column 1 of Schedule 2 and—

(a) in the case of a dangerous substance listed in Table 3.2 part 3 of Annex VI of the

CLP Regulation, it is one or more of the indications of danger specified for that

substance by a symbol-letter in that list;

(b) in the case of any other dangerous substance or a dangerous preparation, it is one or

more indications of danger determined in accordance with the classification of that

substance or preparation in accordance with regulation 4 and the approved

classification and labelling guide;

“mixture” has the same meaning as it has in the CLP Regulation;

“plant protection product” has the same meaning as it has in regulation 2(1) of the Plant

Protection Products Regulations 2005(b) and regulation 2(1) of the Plant Protection Products

(Scotland) Regulations 2005(c);

“the Plant Protection Products Regulations” means the Plant Protection Products Regulations

2005 and the Plant Protection Products (Scotland) Regulations 2005;

“preparation” means a mixture or solution composed of two or more substances;

“radioactive substance” means a substance which contains one or more radionuclides whose

activity or concentration cannot be disregarded as far as radiation protection is concerned;

“receptacle” means a container together with any material, wrapping and component,

including any closure or fastener, associated with the container which enables the container to

perform its containment function;

“REACH” means Regulation (EC) No 1907/2006 of the European Parliament and of the

Council concerning the Registration, Evaluation, Authorisation and Restriction of

Chemicals(d);

“risk phrase” means a risk phrase listed in Annex III of Council Directive 67/548/EEC(e);

“safety phrase” means a safety phrase listed in Annex IV of Council Directive 67/548/EEC;

“substance” means a chemical element and its compounds in the natural state or obtained by

any production process, including any additive necessary to preserve the stability of the

product and any impurity deriving from the process used, but excluding any solvent which

may be separated without affecting the stability of the substance or changing its composition;

(a) 1993 c. 51, to which there are amendments not relevant to these Regulations.(b) S.I. 2005/1435, to which there is an amendment not relevant to these Regulations.

(c) SSI 2005/331, to which there are amendments not relevant to these Regulations.(d) OJ L396, 30.12.2006, p.1.

(e) OJ L196 16.8.67, p.1.

42

“supply” in relation to a substance or preparation means making that substance or preparation

available to another person and includes importation of the substance or preparation into Great

Britain, and “supplier” shall be construed accordingly;

(2) In these Regulations, “package” means—

(a) subject to paragraph (3), the package in which a dangerous substance, dangerous

preparation or preparation specified in regulations 3(6) and 12(3) is supplied,

including the receptacle containing the dangerous substance or preparation in

question; or

(b) a pallet or other device which enables more than one receptacle to be handled as a

unit,

but does not include a container used to transport the dangerous substance or preparation unless

that container is retained by the person to whom the dangerous substance or preparation is

supplied for the purpose of storing that dangerous substance or preparation, and related

expressions shall be construed accordingly.

(3) In the case of supply by way of retail sale, a package does not include any paper or plastic

bag or other form of outer wrapping in which the package is place when it is presented to the

purchaser.

(4) In these Regulations—

(a) where reference is made to a quantity of a dangerous substance or dangerous preparation

expressed in litres, that reference shall mean—

(i) in the case of a liquid, the volume in litres of that liquid;

(ii) in the case of a compressed gas, the volume in litres of the receptacle containing that

gas; and

(iii) in the case of a compressed gas dissolved in a solvent, liquefied gas or solid, the

same number of kilograms of that gas or solid; and

(b) for the purposes of aggregation, one kilogram of a solid shall be deemed to be equivalent

to one litre of liquid or gas.

(5) In these Regulations—

(a) a risk phrase may be designated by the letter “R” followed by a distinguishing number or

combination of numbers; and

(b) a safety phrase may be designated by the letter “S” followed by a distinguishing number

or combination of numbers.

(6) In these Regulations, unless the context otherwise requires, a reference to—

(a) a numbered regulation or Schedule is a reference to the regulation or Schedule in these

Regulations so numbered;

(b) a numbered paragraph is a reference to the paragraph so numbered in the regulation or

Schedule in which that reference occurs, and

(c) a lettered sub-paragraph is a reference to the sub-paragraph so lettered in the paragraph in

which that reference appears.

Application

3.—(1) Subject to paragraphs (3) to (8), these Regulations shall apply to any dangerous

substance or dangerous preparation.

(2) Subject to paragraphs (3) to (8)—

(a) regulation 6 and paragraphs (2) and (4) to (6) of regulation 12 shall apply to the

preparations specified in paragraph (3) of regulation 12; and

(b) paragraphs (1) and (2) of regulation 9 shall apply to a preparation to which section B or C

of Part II of Schedule 4 applies.

(3) These Regulations shall not apply to a substance or preparation which is—

43

(a) intended for use as a medicinal product within the meaning of section 130 of the

Medicines Act 1968(a);

(b) intended for use as a veterinary medical product within the meaning of regulation 2(1) of

the Veterinary Medicines Regulations 2008(b);

(c) intended for use as an investigational medical product within the meaning of the

Medicines for Human Use (Clinical Trials) Regulations 2004(c);

(d) specified in an order made under section 104 or 105 of the Medicines Act 1968(d) which

is for the time being in force and which directs that specified provisions of that Act shall

have effect in relation to medicinal products within the meaning of that Act;

(e) a controlled drug within the meaning of the Misuse of Drugs Act 1971(e) except that

these Regulations shall apply to drugs which are excepted from section 4(1)(b) of that Act

(which makes it unlawful to supply a controlled drug) by Regulations made under section

7(1)(a) of that Act;

(f) a cosmetic product within the meaning of the Cosmetic Products (Safety) Regulations

2008(f);

(g) in the form of waste to which the Waste Management Licensing Regulations 1994, the

Environmental Permitting (England and Wales) Regulations 2007(g) or the Hazardous

Waste (England and Wales) Regulations 2005(h) applies;

(h) intended for use as food within the meaning of section 1 of the Food Safety Act 1990(i);

(i) intended for use as an animal feeding stuff within the meaning of section 66(1) of the

Agriculture Act 1970(j);

(j) radioactive substances or preparations containing radioactive substances; or

(k) a medical device within the meaning of the Medical Devices Regulations 2002(k) which

is invasive or used in direct contact with the human body,

in the finished state, intended for the final user.

(4) These Regulations shall not apply to—

(a) a substance or preparation which is a sample taken by an authority responsible for the

enforcement of any requirement imposed by or under any enactment;

(b) a substance or preparation which is under customs control; or

(c) subject to Regulation (EC) No 689/2008 of the European Parliament and of the Council

of 17 June 2008 concerning the export and import of dangerous chemicals, Annexes I and

V of which are as amended from time to time, a substance or a preparation which is

intended for export to a country which is not an EEA State.

(5) Regulations 6 to 12 shall apply to the preparations specified in paragraph (6) which are

supplied in packages.

(6) Paragraph (5) refers to a preparation which is not a dangerous preparation but which contains

in an individual concentration of � 1% by weight for non-gaseous preparation and � 0.2% by

volume for gaseous preparations—

(a) a dangerous substance which has been classified in respect of its health or environmental

effects; or

(a) 1968 c.67.

(b) 2008/2297.(c) 2004/1031.

(d) as amended by 2004/1031 and 2008/2297, there are other amending instruments but none is relevant.(e) 1971 c.38.

(f) 2008/1284, there is an amending instrument, but it is not relevant.(g) 2007/3538.

(h) 2005/894, as amended by XXX(i) 1990 c.16.

(j) 1970 c.40, as amended by regulation 3(1)(a) of 2005/3281; regulation 3(1)(a) of SSI 2005/605 and regulation 3(1)(a) of 2006/116. There are other amending instruments, but none is relevant.

(k) 2002/618. There are amending instruments, but none is relevant.

44

(b) a substance for which there is a Community workplace exposure limit.

(7) Regulations 6 to 12 shall not apply to munitions and explosives which are supplied with a

view to obtaining an explosive or pyrotechnic effect.

(8) These Regulations shall not apply to the carriage of substances or preparations by rail, road,

inland waterway, sea or air.

PART 2

GENERAL REQUIREMENTS

Classification of dangerous substances and dangerous preparations

4.—(1) Subject to paragraphs (8) to (11), no person shall supply a dangerous substance or

dangerous preparation unless it has been classified in accordance with paragraphs (2) to (7).

(2) The classification of a dangerous substance which is listed in Table 3.2 part 3 of Annex VI

of the CLP Regulation shall be the classification for that substance specified in that list.

(3) A dangerous substance which—

(a) is a new substance not listed in Table 3.2 part 3 of Annex VI of the CLP Regulation; and

(b) has been registered in accordance with Title II of REACH,

shall be classified in conformity with that registration.

(4) Subject to paragraph (5), a dangerous substance which is not classified in accordance with

paragraph (2) or (3) shall be classified—

(a) by ascertaining which of the properties specified in Column 2 of Schedule 1 applies to the

dangerous substance and by placing the dangerous substance in one or more of the

categories of danger specified in the corresponding entry in Column 1 of that part;

(b) by assigning to the dangerous substance the appropriate risk phrases by the use of the

criteria set out in the approved classification and labelling guide; and

(c) where it is proposed to classify a dangerous substance in the category of danger

carcinogenic, mutagenic or toxic for reproduction, by an assessment of the evidence by a

competent person.

(5) Before a dangerous substance is classified in accordance with paragraph (4), persons

carrying out the classification shall make themselves aware of all relevant and accessible data

which may exist in relation to the dangerous substance in question.

(6) Where a manufacturer, distributor or importer has classified a substance, in accordance with

the provisions of paragraph (4), as a dangerous substance in the category of danger carcinogenic,

mutagenic or toxic for reproduction, that person shall send to the Executive as soon as possible a

document—

(a) summarising the information on which the classification was based; and

(b) including all relevant references and unpublished data,

unless that document has already been sent to the relevant authority in another EEA State in which

the dangerous substance has been supplied.

(7) A dangerous preparation shall be classified in accordance with Schedule 3 and, where

applicable, by use of the criteria contained in the approved classification and labelling guide.

(8) Until 30 November 2010, in addition to the requirements of paragraphs (1) to (6), dangerous

substances may also be classified according to Title II of the CLP Regulation.

(9) From 1 December 2010 until 31 May 2015 dangerous substances must be classified in

accordance with paragraphs (1) to (6) and Title II of the CLP Regulation.

(10) Until 31 May 2015, without prejudice to paragraphs (1) to (7), dangerous preparations may

also be classified according to Title II of the CLP Regulation.

45

(11) Paragraphs (1) to (7) shall cease to have effect from 1 June 2015.

Safety data sheets for dangerous substances, dangerous preparations and certain other

preparations

5.The supplier of a dangerous substance or dangerous preparation shall provide the recipient of

that dangerous substance or dangerous preparation with a safety data sheet compiled in accordance

with the requirements of REACH.

Packaging of dangerous substances and preparations

6.—(1) Subject to paragraphs (4) to (7), no person shall supply a dangerous substance,

dangerous preparation or a preparation specified in regulation 12(3) unless it is in a package and—

(a) subject to paragraph (2), the receptacle containing the dangerous substance or dangerous

preparation or a preparation specified in regulation 12(3) is designed and constructed so

that its contents cannot escape;

(b) the materials constituting the packaging and fastenings are not susceptible to adverse

attack by the contents or liable to form dangerous compounds with the contents;

(c) the packaging and fastenings are strong and solid throughout to ensure that they will not

loosen and will meet the normal stresses and strains of handling; and

(d) any replaceable fastening fitted to the receptacle containing the dangerous substance or

dangerous preparation is designed so that the receptacle can be repeatedly refastened

without the contents of the receptacle escaping.

(2) Paragraph (1)(a) shall not apply where a special safety device is fitted to the receptacle.

(3) Packaging and fastenings shall be deemed to comply with the requirements of paragraphs

(1)(a) to (c) if they comply with the relevant requirements of—

(a) the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment

Regulations 2007(a);

(b) the Merchant Shipping (Dangerous Goods and Marine Pollutants) Regulations 1997(b);

or

(c) the Air Navigation (Dangerous Goods) Regulations 2002(c).

(4) Until 30 November 2010 a dangerous substance must be supplied in a package in accordance

with either—

(a) paragraphs (1) to (3); or

(b) Title IV of the CLP Regulation, where a person has chosen to classify a dangerous

substance—

(i) according to Title II of the CLP Regulation, and

(ii) according to regulation 4(1) to (6).

(5) From 1 December 2010 paragraphs (1) to (3) shall cease to have effect in relation to

dangerous substances.

(6) Until 31 May 2015 a dangerous preparation or a preparation specified in regulation 3(6) or

regulation 12(3) must be supplied in a package in accordance with either—



preparation or a preparation specified in regulation 12(3)—


(a) 2007/1573.(b) 1997/2367, as amended by 2004/2110.

(c) 2002/2786.

46


(7) From 31 May 2015 paragraphs (1) to (3) shall cease to have effect in relation to the

packaging of dangerous preparations.

Labelling of dangerous substances and dangerous preparations

7.—(1) Subject to paragraphs (5) to (9) and regulations 8 and 11, no person shall supply a

dangerous substance or dangerous preparation unless the particulars specified in paragraph (2)

relating to a dangerous substance or paragraph (3) relating to a dangerous preparation are clearly

shown in accordance with the requirements of regulation 10—

(a) on the receptacle containing the dangerous substance or dangerous preparation; and

(b) if that receptacle is inside one or more layers of packaging, on any such layer which is

likely to be the outermost layer of packaging during the supply or use of the dangerous

substance or dangerous preparation, unless such packaging permits the particulars shown

on the receptacle or other packaging to be clearly seen.

(2) The particulars required under paragraph (1) in relation to a dangerous substance shall be—

(a) the name, full address and telephone number of a person in an EEA State who is

responsible for supplying the substance, whether the person be its manufacturer, importer

or distributor;

(b) the name of the substance being—

(i) where the substance appears in Table 3.2 part 3 of Annex VI of the CLP Regulation,

the name or one of the names listed therein for that substance; or

(ii) where the substance does not appear in Table 3.2 part 3 of Annex VI of the CLP

Regulation, an internationally recognised name;

(c) the following particulars ascertained in accordance with Part I of Schedule 4, namely—

(i) any indications of danger together with corresponding symbols;

(ii) the risk phrases, set out in full;

(iii) the safety phrases, set out in full; and

(iv) any EC number and, in the case of a substance which is listed in Table 3.2 part 3 of

Annex VI of the CLP Regulation, the words “EC label”; and

(d) where required by paragraph (4) or (5), the labelling phrase specified therein.

(3) the particulars required under paragraph (1) in relation to a dangerous preparation shall be—

(a) the name, full address and telephone number of a person in an EEA State who is

responsible for supplying the preparation, whether that person be its manufacturer,

importer or distributor;

(b) the trade name or other designation of the preparation;

(c) the following particulars ascertained in accordance with Part I of Schedule 4, namely—

(i) identification of the constituents of the preparation which result in it being classified

as a dangerous preparation;

(ii) any indications of danger together with corresponding symbols;

(iii) the risk phrases, set out in full;

(iv) the safety phrases, set out in full;

(v) in the case of a preparation intended for sale to the general public, the nominal

quantity (nominal mass or nominal volume);

(d) where required by paragraph (4) or (5), the labelling phrase specified therein.

(4) Without prejudice to paragraph 4 of Schedule 3 to the Plant Protection Products Regulations,

indications such as “non-toxic”, “non-harmful”, “non-polluting”, “ecological” or any other

statement indicating that the dangerous substance or preparation is not dangerous or that is likely

47

to lead to underestimation of the dangers of the dangerous substance or dangerous preparation

shall not appear on the package.

(5) Where paragraph (6) applies, the packaging of a dangerous substance or dangerous

preparation classified in one or more of the categories of danger harmful, extremely flammable,

highly flammable, flammable, irritant or oxidising shall not be required to be labelled in respect of

that hazardous property.

(6) This paragraph shall apply where the package contains such small quantities of that

substance or preparation that there is no foreseeable risk, under conditions of supply, use and

disposal, arising from that hazardous property to persons handling that substance or preparation to

other persons.

(7) The packaging of a dangerous preparation classified in the category of danger dangerous for

the environment (with or without the “N” symbol) shall not be required to be labelled in respect of

its environmental hazard in accordance with this regulation provided that it contains such small

quantities of that preparation that there is no foreseeable risk, under conditions of supply, use and

disposal, to the environment.

(8) Where the package in which a dangerous substance is supplied does not contain more than

125 millilitres of that substance the risk phrases and safety phrases need not be shown if the

dangerous substance is classified only in one or more of the categories of danger—

(a) highly flammable, flammable, oxidising or irritant; or

(b) harmful, provided the dangerous substance is not sold to the general public.

(9) Where the package in which a dangerous preparation is supplied does not contain more than

125 millilitres of that preparation—

(a) the risk phrases and safety phrases need not be shown if the dangerous preparation is

classified only in one or more of the categories of danger—

(i) irritant (except those assigned the risk phrase R41);

(ii) dangerous for the environment and assigned the N symbol;

(iii) oxidising; or

(iv) highly flammable; and

(b) the safety phrases need not be shown if the dangerous preparation is classified only in one

or more of the categories of danger—

(i) flammable; or

(ii) dangerous for the environment and not assigned the N symbol.

(10) Where a dangerous substance or dangerous preparation is required to be labelled in

accordance with these Regulations and is so labelled, that labelling shall be deemed to satisfy the

requirements of—

(a) section 5 of the Petroleum (Consolidation) Act 1928(a) including that section as applied

to any dangerous substance by an Order in Council made under section 19 of that Act;

(b) regulation 10 of the Dangerous Substances and Explosive Atmospheres Regulations

2002(b) and

(c) regulations 3 and 4 of the Farm and Garden Chemicals Regulations 1971(c).

Labelling of single receptacles and receptacles in outer packagings

8.—(1) Where except for this regulation a package would be required to show the particulars

required by regulation 7 and to be labelled and marked in accordance with any of the national or

international transport rules, it shall be sufficient compliance with regulation 7 if the package

shows the particulars specified in paragraphs (2) or (3) of this regulation.

(a) 1928 c.32.(b) S.I. 2002/2776.

(c) 1971/729, to which there are amendments not relevant to these Regulations.

48

(2) Where the package consists of only a single receptacle, the specified particulars are—

(a) the particulars required by—

(i) paragraph (2)(a), (b), (c)(ii), (iii) and (iv) in the case of substances; and

(ii) paragraph (3)(a), (b), (c)(i), (iii), (iv) and (v) in the case of preparations,

of regulation 7 in accordance with regulation 10;

(b) the labels and markings required by whichever of the national or international transport

rules is appropriate; and

(c) where a substance or preparation has been classified as dangerous for the environment,

the appropriate indication of danger and the danger symbol from Schedule 2 in

accordance with regulation 10.

(3) Where the package consists of one or more receptacles in outer packagings, the particulars

specified are the labels and markings required by whichever of the national or international

transport rules is appropriate.

(4) For the purpose of this regulation and regulation 9(3)—

(a) the national transport rules are—

(i) the Merchant Shipping (Dangerous Goods) Regulations 2002(a);

(ii) the Air Navigation (Dangerous Goods) Regulations 2002(b); and

(iii) the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment

Regulations 2007; and

(b) the international transport rules are—

(i) the European Agreement concerning the International Carriage of Dangerous Goods

by Road signed at Geneva on 30th

September 1957, as revised or reissued from time

to time (“ADR”)(c);

(ii) the European Agreement concerning the International Carriage of Dangerous Goods

by Inland Waterway, as revised or re-issued from time to time (“ADN”)(d);

(iii) the Technical Instructions for the Safe Transport of Dangerous Goods by Air, as

revised or re-issued from time to time (“ICAO”)(e);

(iv) the International Maritime Dangerous Goods Code, as revised or re-issued from time

to time (“IMDG”)(f); and

(v) the Regulation concerning the International Carriage of Dangerous Goods by Rail

including its Annex (“RID” which together form Appendix C to the Convention

concerning the International Carriage by Rail (“COTIF”)(g), as revised or re-issued

from time to time.

Particular labelling requirements for certain preparations

9.—(1) Subject to regulation 11, in the case of preparations to which Part II of Schedule 4

applies, the appropriate provisions of that Part shall have effect to regulate the labelling of such

preparations.

(2) Subject to regulations 7 and 8, no person shall supply a preparation to which section B or C

of Part II of Schedule 4 applies unless the trade name or other designation of that preparation and

the name, full address and telephone number of a person in an EEA state who is responsible for

(a) 1997/2367, as amended by 2004/2110.

(b) 2002/2786, as amended by 2008/1943 and 2008/2429.(c) Current edition (2003): ISBN 92-1-139078-8. Existing corrigenda are corrigendum 1 (February 2003) and Corrigendum 2

(June 2003).(d) Current edition (2003)

(e) Current edition (2003-2004): ISBN 92-9194-010-0.(f) Current edition . (2002): I SBN 92-801-5140-1.

(g) Current edition: (2003): ISBN 0-11-552553-X.

49

supplying that preparation (whether the person is its manufacturer, importer or distributor) are

clearly shown in accordance with the requirements of regulation 10—

(a) on the receptacle containing that preparation; and

(b) if that receptacle is inside one or more layers of packaging, on any such layer which is

likely to be the outermost layer of packaging during the supply or use of that preparation,

unless such packaging permits the particulars shown on the receptacle or other packaging

to be clearly seen.

(3) Where a package would be required to be labelled and marked in accordance with any of the

national or international transport rules listed in regulation 8(4) and the package consists of one or

more receptacles in outer packagings, it shall be sufficient compliance with paragraph (2) if the

package shows the labels and markings required by whichever of the national or international

rules is appropriate.

(4) The supplier of an aerosol dispenser which contains a dangerous substance or dangerous

preparation which has been classified in the category of danger “flammable”, “highly flammable”

or “extremely flammable” may choose to omit from the label—

(a) in the case of a dangerous substance, the particulars referred to in paragraphs (i) to (iii) of

regulation 7(2)(c) which relate to that category of danger; and

(b) in the case of a dangerous preparation, the particulars referred to in paragraphs (ii) to (iv)

of regulation 7(3)(c) which relate to that category of danger,

provided the conditions specified in (5) are satisfied.

(5) The conditions referred to in paragraph (4) are that the supplier—

(a) is in possession of evidence which shows that the contents of the aerosol dispenser do not

present a risk of ignition under normal or reasonably foreseeable conditions of use; and

(b) identifies the quantity of flammable material contained in the aerosol dispenser in the

form of the following inscription on the label—

“X% by mass of the contents are flammable”.

(6) In the case of a plant protection product approved under the Plant Protection Products

Regulations or a product approved under the Control of Pesticides Regulations 1986(a), the

labelling information required by these Regulations shall be accompanied by the wording “To

avoid risks to man and the environment, comply with the instructions for use”.

Methods of marking or labelling packages

10.—(1) Subject to regulation 11, any package which is required to be labelled in accordance

with regulations 7 to 9 may carry the particulars required to be on the label clearly and indelibly

marked on a part of that package reserved for that purpose and, unless the context otherwise

requires, any reference in these Regulations to a label includes a reference to that part of the

package so reserved.

(2) Subject to paragraph (7), any label required to be carried on a package must be securely

fixed to the package with its entire surface in contact with it and the label must be clearly and

indelibly printed.

(3) The colour and nature of the marking shall be such that any symbol and the wording stand

out clearly from the background and the wording shall be of such size and spacing as to be easily

read.

(4) The package must be so labelled that the particulars can be read horizontally when the

package is set down normally.

(5) Subject to paragraph (7), the dimensions of the label required under regulation 7 must be as

follows—

(a) S.I. 1986/1510, to which there are amendments not relevant to these Regulations.

50

Capacity of package Dimensions of label

(a) not exceeding 3 litres if possible at least 52 x 74 millimetres

(b) exceeding 3 litres but not exceeding 50

litres

at least 74 x 105 millimetres

(c) exceeding 50 litres but not exceeding

500 litres

at least 105 x 148 millimetres

(d) exceeding 500 litres at least 148 x 210 millimetres

(6) A symbol required to be shown in accordance with regulation 7(2)(c)(i) or 7(3)(c)(ii) and

specified in column 3 of Schedule 2 must be printed in black on an orange-yellow background and

its size (including the orange-yellow background) must be at least equal to an area of one-tenth of

that of a label which complies with paragraph (5) and must not in any case be less than 100 square

millimetres.

(7) If the package is an awkward shape or so small that it is unsuitable to attach a label

complying with paragraphs (2) and (5), the label must be attached in some other appropriate

manner.

Transitional provisions for labelling dangerous substances and preparations

11.—(1) Until 30 November 2010 a dangerous substance must be supplied in accordance with

the labelling requirements of either—

(a) regulations 7 to 10; or

(b) Title III of the CLP Regulation, where a person has chosen to classify a dangerous

substance or substance falling within regulation 12(3)—



(2) From 1 December 2010 regulations 7 to 10 shall cease to have effect in relation to the

labelling of substances.

(3) Until 31 May 2015 a dangerous preparation or a preparation falling within regulation 9(1) or

regulation 3(6) or regulation 12(3) must be supplied in accordance with the labelling requirements

of either—

(a) regulations 7 to 10; or

(b) Title III of the CLP Regulation, where a person has chosen to classify a dangerous

preparation or a preparation specified in regulation 3(6) or 12(3)—



(4) From 1 June 2015 regulations 7 to 10 shall cease to have effect in relation to the labelling of

dangerous preparations.

Child resistant fastenings, tactile warning devices and other consumer protection measures

12.—(1) The British Standards referred to in this regulation are further described in Schedule 5.

(2) Subject to paragraphs (4) and (5), no person shall supply to the general public a substance or

a preparation specified in paragraph (3) in a receptacle of any size fitted with—

(a) a replaceable closure unless the packaging complies with the requirements of BS EN

28317; or ISO 8317; or

(b) a non-replaceable closure unless the packaging complies with the requirements of EN

862.

(3) The substances and preparations referred to in paragraph (2) are—

51

(a) dangerous substances and dangerous preparations which are required to be labelled with

the indication of danger “very toxic”, “toxic” or “corrosive”;

(b) preparations containing methanol in a concentration equal to or more than 3% by weight;

(c) preparations containing dichloromethane in a concentration equal to or more than 1% by

weight;

(d) substances which are assigned the risk phrase R65 in Table 3.2 part 3 of Annex VI of the

CLP Regulation, except where such a substance or preparation is supplied in an aerosol

dispenser or a container fitted with a sealed spray attachment; and

(e) substances and preparations which are assigned the risk phrase R65 and are classified and

labelled according to the approved classification and labelling guide, except where such a

substance or preparation is supplied in an aerosol dispenser or a container fitted with a

sealed spray attachment.

(4) Paragraph (2) shall not apply if the person supplying the substance or preparation in question

can show that it is obvious that the packaging in which the substance or preparation is supplied is

sufficiently safe for children because they cannot obtain access the contents without the help of a

tool.

(5) If the packaging, in which a substance or preparation specified in paragraph (3) is supplied to

the general public, was approved on or before 31 May 1993 by the British Standards Institution as

complying with the requirements of BS 6652, that packaging shall be deemed to comply with the

requirements of BS EN 28317.

(6) No person shall supply a dangerous preparation or a preparation specified in paragraph (3) to

the general public if the packaging in which that preparation is supplied has—

(a) either a shape or a designation or both likely to attract or arouse the active curiosity of

children or to mislead consumers; or

(b) either a presentation or a designation or both used for—

(i) human or animal foodstuffs,

(ii) medicinal products, or

(iii) cosmetic products.

(7) Subject to paragraph (9), no person shall supply to the general public a dangerous substance

or a dangerous preparation specified in paragraph (8) in a receptacle of any size, unless the

packaging in which that dangerous substance or dangerous preparation is supplied carries a tactile

warning of danger in accordance with EN ISO 11683.

(8) The dangerous substances and the dangerous preparations referred to in paragraph (7) are

those which are required to be labelled with one or more of the following indications of danger,

namely—

(a) very toxic,

(b) toxic;

(c) corrosive;

(d) harmful;

(e) extremely flammable; or

(f) highly flammable.

(9) Paragraph (7) shall not apply to an aerosol dispenser which is classified and labelled only

with the indication of danger extremely flammable or highly flammable.

(10) For the purpose of ascertaining whether there has been a contravention of paragraph (2), a

duly authorised officer of the enforcing authority may require the person supplying a substance or

a preparation to which that paragraph applies to provide that person with a certificate from a

qualified test house stating that—

(a) the closure is such that it is not necessary to test to BS EN 28317 or ISO 8317; or

(b) the closure has been tested and found to conform to BS EN 28317 or ISO 8317.

52

(11) In this regulation, “qualified test house” means a laboratory that conforms to BS 7501 or

EN 45 000.

(12) Until 30 November 2010 a dangerous substance falling within paragraph (3) must be

supplied in a package and labelled in accordance with either—



substance—



(13) From 1 December 2010 paragraphs (2) to (11) shall cease to have effect in relation to the

packaging and labelling of dangerous substances.

(14) Until 31 May 2015 a preparation falling within paragraph (3) shall be supplied in a package

and labelled in accordance with either—



preparation—



(15) From 1 June 2015 paragraphs (2) to (11) shall cease to have effect in relation to the

packaging of dangerous preparations.

Retention of data for dangerous preparations

13.—(1) The person who is responsible for first supplying a dangerous preparation shall

maintain a record of the information—

(a) used for the purposes of classifying that dangerous preparation in accordance with

regulation 4;

(b) used for the purposes of labelling that dangerous preparation in accordance with

regulations 7 and 10;

(c) relating to any child resistant fastening or any tactile warning of which forms part of the

packaging in which the dangerous preparation in question is contained; and

(d) used for the purposes of preparing the safety data sheet relating to that dangerous

preparation in accordance with regulation 5.

(2) When requested by the enforcing authority to do so, a person referred to in paragraph (1)

shall make the record, or a copy of the record, maintained by the person in accordance with that

paragraph, available to the enforcing authority within 28 days of the date of the request.

(3) When requested to do so by the enforcing authority, a person who supplies a dangerous

preparation shall provide to the enforcing authority a copy of any certificate issued by a qualified

test house.

(4) Until 31 May 2015 data must be retained for dangerous preparations in accordance with

either—


(b) Article 49 of Title VII of the CLP Regulation, where a person has chosen to classify a

dangerous preparation—

(i) according to Title II of the CLP Regulation; and


(5) From 1 June 2015 paragraphs (1) to (3) shall cease to have effect.

53

PART 3

MISCELLANEOUS

Enforcement

14.—(1) To the extent that they would not otherwise do so, sections—

(a) 16 to 28 (approval of codes of practice; enforcement; indemnification of inspectors;

power to obtain information and restrictions on disclosure of information);

(b) 33 to 42 (provisions as to offences); and

(c) 47(2) (civil liability),

of the 1974 Act shall apply to these Regulations and any requirement or prohibition imposed upon

any supplier within the meaning of the CLP Regulation of a substance, mixture or article falling

within the provisions of the CLP Regulation as if the requirement, prohibition or regulations were

imposed by regulation 15 of that Act.

(2) Any function of the Health and Safety Executive under any other provision of the 1974 Act

under or in respect of health and safety Regulations (including their enforcement) shall be

exercisable as if these Regulations and the CLP Regulation were health and safety Regulations for

the purposes of that Act to the extent that they would not otherwise do so.

(3) Notwithstanding regulation 3 of the Health and Safety (Enforcing Authority) Regulations

1998(a) and subject to paragraphs (4) and (5), the enforcing authority for these Regulations and

the CLP Regulation shall be the Executive.

(4) Subject to paragraphs (3) and (5), where a substance or preparation is supplied, or a

substance, mixture or article falling within the provisions of the CLP Regulation is placed on the

market within the meaning of the CLP Regulation in or from premises which are registered under

section 75 of the Medicines Act 1968(b), the enforcing authority shall be the Royal

Pharmaceutical Society.

(5) The enforcing authority for these Regulations and the CLP Regulation shall be the local

weights and measures authority—

(a) where a substance or preparation is supplied or a substance, mixture or article falling

within the provisions of the CLP Regulation is placed on the market within the meaning

of the CLP Regulation other than in the circumstances referred to in paragraph (4),—

(i) in or from any shop, mobile vehicle, market stall or other retail outlet, or

(ii) otherwise to members of the public, including by way of free sample, prize or mail

order;

(b) for regulation 12.

(6) In every case where, by virtue of this regulation and the CLP Regulation, these Regulations

and the CLP Regulation are enforced by the Royal Pharmaceutical Society or the local weights

and measures authority, they shall be enforced as if they were safety regulations made under

section 11 of the Consumer Protection Act 1987(c) and the provisions of section 12 of that Act

shall apply to these Regulations and the CLP Regulation as if they were health and safety

regulations and as if the maximum period of imprisonment on summary conviction specified in

subsection (5) thereof were 3 months instead of 6 months.

(7) A failure to discharge a duty placed by the CLP Regulation on the competent authority shall

not be an offence under section 33(1)(c) of the 1974 Act.

(a) S.I. 1998/494 to which there are amendments not relevant to these Regulations.(b) c.67.

(c) 1987 c.43.

54

Defence

15.In any proceedings for an offence for a contravention of any of the provisions of these

regulations and the CLP Regulation it shall be a defence for the person charged to prove that the

person took all reasonable precautions and exercised all due diligence to avoid the commission of

the offence.

Extension outside Great Britain

16.These Regulations and the CLP Regulation shall apply to any activity outside Great Britain

to which sections 1 to 59 and 80 to 82 of the 1974 Act apply by virtue of the Health and Safety at

Work etc. Act 1974 (Application outside Great Britain) Order 2001(a) as they apply to activities

within Great Britain.

Revocations

17.The instruments specified in column x of Schedule x shall be revoked to the extent specified

in the corresponding entry in column 3 of that Schedule.

SCHEDULE 1 Regulations 2(1) and 4(4)

Classification of Dangerous Substances and Dangerous preparations

Categories of Danger

Column 1

Category of danger

Column 2

Property (See Note 1)

Column 3

Symbol-letter

Physico-Chemical Properties

Explosive Solid, liquid, pasty or gelatinous substances and

preparations which may react exothermically

without atmospheric oxygen thereby quickly

evolving gases, and which under defined test

conditions detonate , quickly deflagrate or upon

heating explode when partially confined.

E

Oxidising Substances and preparations which give rise to a

highly exothermic reaction in contact with other

substances, particularly flammable substances.

O

Extremely flammable Liquid substances and preparations having an

extremely low flash point and a low boiling

point and gaseous substances and preparations

which are flammable in contact with air at

ambient temperature and pressure.

F+

Highly flammable The following substances and preparations,

namely—

(a) substances and preparations which may

become hot and finally catch fire in

contact with air at ambient temperature

without application of energy;

(b) solid substances and preparations which

may readily catch fire after brief contact

with a source of ignition and which

F

(a) S.I. 2001/2127.

55

continue to burn or to be consumed

after removal of the source of ignition;

(c) liquid substances and preparations

having a very low flash point; or

(d) substances and preparations which, in

contact with water or damp air, evolve

extremely flammable gases in

dangerous quantities.

Flammable Liquid substances and preparations having a low

flash point.

none

Health Effects

Very toxic Substances and preparations which in very low

quantities cause death or acute or chronic

damage to health when inhaled, swallowed or

absorbed via the skin.

T+

Toxic Substances and preparations which in low

quantities cause death or acute or chronic

damage to health when inhaled, swallowed or

absorbed via the skin.

T

Harmful Substances and preparations which may cause

death or acute or chronic damage to health when

inhaled, swallowed or absorbed via the skin.

Xn

Corrosive Substances and preparations which may, on

contact with living tissues, destroy them.

C

Irritant Non-corrosive substances and preparations

which, through immediate, prolonged or

repeated contact with the skin or mucous

membrane, may cause inflammation.

Xi

Sensitising Substances and preparations which, if they are

inhaled or if they penetrate the skin, are capable

of eliciting a reaction by hypersensitization such

that on further exposure to the substance or

preparation, characteristic adverse effects are

produced.

Sensitising by inhalation Xn

Sensitising by skin

contact

Xi

Carcinogenic (See Note

2)

Substances and preparations which, if they are

inhaled or ingested or if they penetrate the skin,

may induce cancer or increase its incidence.

Category 1 T

Category 2 T

Category 3 Xn

Mutagenic (See Note 2) Substances and preparations which, if they are


may induce heritable genetic defects or increase

their incidence.

Category 1 T

Category 2 T

Category 3 Xn

Toxic for reproduction Substances and preparations which, if they are


may produce or increase the incidence of non-

heritable adverse effects in the progeny and/or of

male or female reproductive functions or

56

capacity.

Category 1 T

Category 2 T

Category 3 Xn

Environmental Effects

Dangerous for the

environment (See Note

3)

Substances and preparations which, were they to

enter into the environment, would present or

might present an immediate or delayed danger

for one or more components of the environment.

N

Notes

1. As further described in the approved classification and labelling guide.

2.The categories are specified in the approved classification and labelling guide.

3.In certain cases specified in Table 3.2 part 3 of Annex VI of the CLP Regulation and in the

approved classification and labelling guide substances and preparations classified as dangerous for

the environment do not require to be labelled with the symbol and indication of danger.


Indications of Danger and Symbols for Dangerous Substances and Dangerous preparations

Column 1

Indication of danger

Column 2

Symbol-letter

Column 3

Symbol

Explosive E

Oxidising O

Extremely flammable F+

Highly flammable F

Very toxic T+

57

Toxic T

Harmful Xn

Corrosive C

Irritant Xi

Dangerous for the

environment

N


Provisions for Classifying Dangerous preparations

Part 1

General Provisions

Application

1.The provisions of this Schedule shall apply for the classification of preparations.

Interpretation and application

2.—(1) In this Schedule, for the purposes of classification—

58

“physico-chemical properties” means the properties to be applied for the classifications

“explosive”, “oxidising”, “extremely flammable”, “highly flammable” or “flammable”;

“health effects” means the effects to be assessed for the classifications “very toxic”, “toxic”,

“harmful”, “corrosive”, “irritant”, “sensitising”, “carcinogenic”, “mutagenic” or “toxic for

reproduction”; and

“environmental hazards” means the hazards to be assessed for the classification “dangerous for the

environment”.

(2) In its application to preparations that are gases, this Part shall be modified so that reference

to concentrations expressed as percentage by weight are to concentrations expressed as the same

percentage by volume.

Classification of preparations by physico-chemical properties

3.—(1) The requisite physico-chemical properties for the classification of preparations shall be

determined in accordance with the criteria set out in the approved classification and labelling

guide.

(2) Subject to sub-paragraph (3), preparations shall be classified as explosive, oxidising,

extremely flammable, highly flammable or flammable when they satisfy the criteria referred to in

sub-paragraph (1) for the category of danger.

(3) The determination of explosive, oxidising, extremely flammable, highly flammable or

flammable properties is not necessary provided that—

(a) none of the constituents possess such properties and that, on the basis of information

available to the manufacturer, the preparation is unlikely to present dangers of this kind;

(b) in the event of a change in composition of a preparation of known composition, scientific

evidence indicates that a reassessment of the hazards will not lead to a change in

classification; and

(c) in the case of a preparation supplied in the form of an aerosol, that preparation satisfies

the provisions of article 8(1)(a) of Council Directive 75/324/EEC(a).

Classification of preparations by health effects

4.—(1) The health effects of a preparation must be assessed by one or more of the following

methods—

(a) by the conventional method described in the following paragraphs using concentration

limits; or

(b) by the criteria set out in the approved classification and labelling guide in relation to the

preparation for an appropriate classification and label.

(2) Any one or more of the health effects of the preparation which are not assessed by the

method set out in sub-paragraph (1)(b) must be assessed in accordance with the conventional

method.

(3) Where the health effects have been established by both methods, the results of the method

set out in sub-paragraph (1)(b) must be used for classifying the preparation except in the case of

carcinogenic and mutagenic effects and toxic effects for reproduction, when the conventional

method set out in sub-paragraph (1)(a) must always be used.

(4) Where it can be demonstrated—

(a) by epidemiological studies, by scientifically valid case studies as specified in the

approved classification and labelling guide or by statistically backed experience (such as

the assessment of data from poison information units or concerning occupational

diseases) that toxicological effects on man differ from those suggested by the application

(a) OJ No. L147, 9.6.1975, p.40.. Article 8 is amended by Commission Directive 2008/47/EC, OJ No L96, 9.4.2008, p.15.

59

of the methods set out in paragraph (1), then the preparation must be classified according

to its effects on man;

(b) that owing to effects such as potentiation, a conventional assessment would underestimate

the toxicological hazard, those effects must be taken into account in classifying the

preparation; or

(c) that owing to effects such as antagonism, a conventional assessment would overestimate

the toxicological hazard, those effects must be taken into account in classifying the

preparation.

(5) Subject to sub-paragraph (6), for preparations of a known composition, with the exception of

plant protection products, classified in accordance with the method set out in sub-paragraph (1)(b),

a new health effect assessment must be performed either by the method set out in sub-paragraph

(1)(a) or (1)(b) whenever—

(a) changes of composition of the initial concentration, as a weight/ weight or volume/

volume percentage, of one or more of the dangerous constituents are introduced by the

manufacturer which exceed the permitted variations set out in the following table—

Initial concentration range of the

constituent

Permitted variation in actual concentration of the

constituent

� 2.5% ± 30%

> 2.5 � 10% ± 20%

> 10 � 25% ± 10%

> 25 � 100% ± 5%

or,

(b) changes of composition involving the substitution or addition of one or more constituents,

which may or may not be dangerous within the definitions in Schedule 1, are introduced

by the manufacturer.

(6) The revised assessment required by paragraph (5) shall not be required where there is a valid

scientific justification for considering that a re-evaluation of the hazard will not result in a change

of classification.

Classification for health effects by the conventional method

5.—(1) In accordance with paragraph 4(1)(a), the health effects must be assessed by the

conventional method described below using concentration limits.

(2) Where the substances concerned are dangerous substances and are listed as dangerous

substances in Table 3.2 part 3 of Annex VI of the CLP Regulation and are assigned concentration

limits necessary for the application of the method of assessment described below, these

concentration limits must be used.

(3) Where the substances concerned are dangerous substances and do not appear in Annex VI of

Table 3.2 part 3 of the CLP Regulation as dangerous substances or appear there without the

concentration limits necessary for the application of the method of evaluation described below, the

concentration limits must be assigned in accordance with Part II of this Schedule.

Lower limits of concentration

6.—(1) For preparations to which this Schedule applies, account must be taken of dangerous

substances which are classified as dangerous on the basis of their health or environmental effects

(whether they are present as additives or impurities) when their concentrations are equal to or

greater than those defined in the following table unless lower limits are given in Table 3.2 part 3

of Annex VI of the CLP Regulation or in Part II of this Schedule—

60

Concentration to take into consideration forCategory of danger of the substance

gaseous preparations

% vol/vol

other preparations % w/w

Very toxic �0.02 �0.1

Toxic �0.02 �0.1

Carcinogenic

Category 1 or 2

�0.02 �0.1

Mutagenic

Category 1 or 2

�0.02 �0.1

Toxic for reproduction

Category 1 or 2

�0.02 �0.1

Harmful �0.2 �1

Corrosive �0.02 �1

Irritant �0.2 �1

Sensitising �0.2 �1

Carcinogenic

Category 3

�0.2 �1

Mutagenic

Category 3

�0.2 �1

Toxic for reproduction

Category 3

�0.2 �1

Dangerous for the environment N �0.1

Dangerous for the environment

ozone

�0.1 �0.1

Dangerous for the environment �1

(2) Some substances may have more than one health effect and each of these properties must be

characterised by its specific concentration limit.

Classification by the conventional method as very toxic

7.—(1) The following preparations must be classified as very toxic owing to their acute lethal

effects and assigned the symbol “T+”, the indication of danger “very toxic” and the risk phrase

R26, R27 or R28—

(a) preparations containing one or more substances classified as very toxic that produce such

effects, in individual concentrations equal to or exceeding—

(i) either the concentration specified in Table 3.2 part 3 of Annex VI of the CLP

Regulation for the substance or substances under consideration, or

(ii) the concentration specified in paragraph 1of Part II of this Schedule (Table I or Table

IA) where the substance or substances do not appear in Table 3.2 part 3 of Annex VI

of the CLP Regulation or appear in it without concentration limits; and

(b) preparations containing more than one substance classified as very toxic in lower

individual concentrations than the limits specified in Table 3.2 part 3 of Annex VI of the

CLP Regulation or in paragraph 1 of Part II of this Schedule (Table I or Table IA), if the

sum of the quotients obtained by dividing the percentage weight of each very toxic

substance in the preparation by the very toxic limit specified for that substance is 1 or

more, i.e.—

61

where—

PT+ is the percentage by weight of each very toxic substance in the

preparation;

LT+ is the very toxic limit specified for each very toxic substance expressed

as a percentage by weight or by volume.

(2) The following preparations must be classified as very toxic owing to their non-lethal

irreversible effects after a single exposure and assigned the symbol “T+”, the indication of danger

“very toxic” and the risk phrase R39/route of exposure—

Preparations containing one or more dangerous substances which produce such effects in

individual concentrations equal to or exceeding—



(ii) the concentration specified in paragraph 2 of Part II of this Schedule (Table II or

Table IIA) where the substance or substances do not appear in Table 3.2 part 3 of

Annex VI of the CLP Regulation or appear in it without concentration limits.

Classification by the conventional method as toxic

8.—(1) The following preparations must be classified as toxic owing to their acute lethal effects

and assigned the symbol “T”, the indication of danger “toxic” and the risk phrase R23, R24, or

R25—

(a) preparations containing one or more substances classified as very toxic or toxic that

produce such effects in individual concentrations equal to or exceeding—



(ii) the concentration specified in paragraph 1 of Part II of this Schedule (Table I or

Table IA) where the substance or substances do not appear in Table 3.2 of part 3 of

Annex VI of the CLP Regulation or appear in Table 3.2 without concentration limits:

(b) preparations containing more than one substance classified as very toxic or toxic in lower

individual concentrations than the limits specified in Table 3.2 part 3 of Annex VI of the

CLP Regulation or in paragraph 1 of Part II of this Schedule (Table I or Table IA) if the

sum of the quotients obtained by dividing the percentage weight of each very toxic or

toxic substance in the preparation by the toxic limit specified for that substance is 1 or

more, i.e.—

where—

PT+ is the percentage by weight or by volume of each very toxic substances in the

preparation.

PT is the percentage by weight or by volume of each toxic substance in the

preparation.

LT is the respective toxic limit specified for each very toxic or toxic substance

expressed as a percentage by weight or by volume.

(2) The following preparations must be classified as toxic owing to their non-lethal irreversible

effects after a single exposure and assigned the symbol “T”, the indication of danger “toxic” and

the risk phrase R39/route of exposure—

62

Preparations containing one or more dangerous substances classified as very toxic or toxic which

produce such effects in individual concentrations equal to or exceeding—






(3) The following preparations must be classified as toxic owing to their long-term effects and

assigned the symbol “T”, the indication of danger “toxic” and the risk phrase R48/route of

exposure—

Preparations containing on or more dangerous substances which produce such effects in individual

concentrations equal to or exceeding—



(ii) the concentration specified in paragraph 3 of Part II of this Schedule (Table III or

Table IIIA) where the substance or substances do not appear in Table 3.2 part 3 of


Classification by the conventional method as harmful

9.—(1) The following preparations must be classified as harmful owing to their acute lethal

effects and assigned the symbol “Xn”, the indication of danger “harmful” and the risk phrase R20,

R21 or R22—

(a) preparations containing one or more substances classified as very toxic, toxic or harmful

and that produce such effects in individual concentrations equal to or exceeding—



(ii) the concentration specified in paragraph 1 of Part II of this Schedule (Table I or


Annex VI of the CLP Regulation or appear in it without concentration limits;

(b) preparations containing more than one substance classified as very toxic, toxic or harmful

in lower individual concentrations than the limits specified in Table 3.2 part 3 of Annex

VI of the CLP Regulation or in paragraph 1 of Part II of this Schedule (Table I or Table

IA) if the sum of the quotients obtained by dividing the percentage weight of each very

toxic, toxic or harmful substance in the preparation by the harmful limit specified for that

substance is 1 or more, i.e.—

where—

PT+ is the percentage by weight or by volume of each very toxic substance in the

preparation,

PT is the percentage by weight or by volume of each toxic substance in the

preparation,

PXn is the percentage by weight or by volume of each harmful substance in the

preparation,

LXn is the respective harmful limit specified for each very toxic, toxic or harmful

substance expressed as a percentage by weight or by volume.

63

(2) The following preparations must be classified as harmful owing to their acute effects to the

lungs if swallowed and assigned the symbol “Xn”, the indication of danger “harmful” and the risk

phrase R65—

Preparations classified as harmful according to the criteria specified in the Approved

Classification and Labelling Guide.

In applying the conventional method according to sub-paragraph (1), no account shall be

taken of the classification of a substance as R65.

(3) The following preparations must be classified as harmful owing to their non-lethal

irreversible effects after a single exposure and assigned the symbol “Xn”, the indication of danger

“harmful” and the risk phrase R68/route of exposure—

Preparations containing one or more dangerous substances classified as very toxic, toxic

or harmful which produce such effects in individual concentrations equal to or

exceeding—






(4) The following preparations must be classified as harmful owing to their long-term effects

and assigned the symbol “Xn”, the indication of danger “harmful” and the risk phrase R48/ route

of exposure—

Preparations containing one or more dangerous substances classified as toxic or harmful

that produce such effects in individual concentrations equal to or exceeding—



(ii) the concentration specified in paragraph 3 of Part II of this Schedule (Table III or

Table IIIA) where the substance or substances do not appear in Table 3.2 part 3 of


Classification by the conventional method as corrosive

10.—(1) The following preparations must be classified as corrosive and assigned the symbol

“C”, the indication of danger “corrosive” and the risk phrase R35—

(a) preparations containing one or more substances classified as corrosive to which is

assigned the risk phrase R35 in individual concentrations equal to or exceeding—

(i) either the concentration specified in Annex VI of the CLP Regulation for the

substance or substances under consideration, or

(ii) the concentration specified in paragraph 4 of Part II of this Schedule (Table IV or

Table IVA) where the substance or substances do not appear in Annex VI of the CLP

Regulation or appear in it without concentration limits;

(b) preparations containing more than one substance classified as corrosive to which is

assigned the risk phrase R35 in lower individual concentrations than the limits specified

either in Annex VI of the CLP Regulation or in paragraph 4 of Part II of this Schedule

(Table IV or Table IVA) if the sum of the quotients obtained by dividing the percentage

weight of each corrosive substance in the preparation by the corrosive limit R35 specified

for that substance is 1 or more, i.e.—

where—

64

PC. R35 is the percentage by weight or by volume of each corrosive substance to which is

assigned the risk phrase R35 in the preparation,

LC. R35 is the corrosive limit R35 specified for each corrosive substance to which is

assigned the risk phrase R35 expressed as a percentage by weight or by volume.

(2) The following preparations must be classified as corrosive and assigned the symbol “C”, the

indication of danger “corrosive” and risk phrase R34—


assigned the risk phrase R35 or R34 in individual concentrations equal to or exceeding—


Regulation for substance or substances under consideration, or


Table IVA) where the substance or substances do not appear in Table 3.2 part 3 of


(b) preparations containing more than one substance classified as corrosive to which is

assigned the risk phrase R35 or R34 in lower individual concentrations than the limits

specified either in Table 3.2 part 3 of Annex VI of the CLP Regulation or in paragraph 4

of Part II of this Schedule (Table IV or Table IVA) if the sum of the quotients obtained

by dividing the percentage weight of each corrosive substance in the preparation by the

corrosive limit R34 specified for that substance is 1 or more, i.e.—

where—





LC. R34 is the respective corrosive limit R34 specified for each corrosive substance to

which is assigned the risk phrase R35 or R34 expressed as a percentage by

weight or by volume.

Classification by the conventional method as irritant

11.—(1) The following preparations must be classified as irritants liable to cause serious eye

damage and assigned the symbol “Xi”, the indication of danger “irritant” and risk phrase R41—

(a) preparations containing one or more substances classified as irritant to which is assigned

the risk phrase R41 in individual concentrations equal to or exceeding—






(b) preparations containing more than one substance classified as irritant to which is assigned

the risk phrase R41, or classified as corrosive and to which is assigned the risk phrase

R35 or R34, in lower individual concentrations than the limits specified either in Table

3.2 part 3 of Annex VI of the CLP Regulation or in paragraph 4 of Part II of this Schedule

65

(Table IV or Table IVA) if the sum of the quotients obtained by dividing the percentage

weight of each corrosive substance in the preparation by the corrosive limit R41 specified

for that substance is 1 or more, i.e.—

where—





PXi R41 is the percentage by weight or by volume of each irritant substance to which is


LXi.

R41

is the respective irritant limit R41 specified for each corrosive substance to

which is assigned the risk phrase R35 or R34 or irritant substance to which is

assigned the risk phrase R41, expressed as a percentage by weight or by volume.

(2) The following preparations must be classified as irritant to eyes and assigned the symbol

“Xi”, the indication of danger “irritant” and risk phrase R36—


assigned the risk phrase R35 or R34 or as irritant to which is assigned the risk phrase R41

or R36 in individual concentrations equal to or exceeding—







the risk phrase R41 or R36 or as corrosive and to which is assigned the risk phrase R35 or

R34, in lower individual concentrations than the limits specified either in Table 3.2 part 3

of Annex VI of the CLP Regulation or in paragraph 4 of Part II of this Schedule (Table

IV or Table IVA) if the sum of the quotients obtained by dividing the percentage weight

of each irritant substance in the preparation by the irritant limit R36 specified for that


where—

66









LXi. R41 is the respective irritant limit R36 specified for each corrosive substance to


assigned the risk phrase R41 or R36, expressed as a percentage by weight or by

volume.

(3) The following preparations must be classified as irritant to skin and assigned the symbol

“Xi”, the indication of danger “irritant” and risk phrase R38—

(a) preparations containing one or more substances classified as irritant and to which is

assigned the risk phrase R38 or as corrosive and to which is assigned the risk phrase R35

or R34 in individual concentrations equal to or exceeding—







the risk phrase R38 or as corrosive and to which is assigned the risk phrase R35 or R34,

in lower individual concentrations than the limits specified either in Table 3.2 part 3 of

Annex VI of the CLP Regulation or in paragraph 4 of Part II of this Schedule (Table IV

or Table IVA) if the sum of the quotients obtained by dividing the percentage weight of

each irritant substance in the preparation by the irritant limit R38 specified for that


where—







LXi. R38 is the respective irritant limit R38 specified for each corrosive substance to



67

(4) the following preparations must be classified as irritant to the respiratory system and

assigned the symbol “Xi”, the indication of danger “irritant” and risk phrase R37—

(a) preparations containing one or more substances classified as irritant to which is assigned

the risk phrase R37 in individual concentrations equal to or exceeding—

(i) either the concentration specified in Annex VI of the CLP Regulation for substance

or substances under consideration, or


Table IVA) where the substance or substances do not appear in Annex VI of the CLP

Regulation or appear in it without concentration limits;


the risk phrase R37 in lower individual concentrations than the limits specified either in

Annex VI of the CLP Regulation or in paragraph 4 of Part II of this Schedule (Table IV

or Table IVA) if the sum of the quotients obtained by dividing the percentage weight of

each irritant substance in the preparation by the irritant limit R37 specified for that


where—



LXi.

R37

is the respective irritant limit R37 specified for each corrosive substance to



(c) gaseous preparations containing more than one substance classified as irritant to which is

assigned the risk phrase R37 or as corrosive and to which is assigned the risk phrase R35

or R34 in lower individual concentrations than the limits specified either in Table 3.2 part

3 of Annex VI of the CLP Regulation or in paragraph 4 of Part II of this Schedule (Table

IV or Table IVA) if the sum of the quotients obtained by dividing the percentage weight

of each substance in the preparation by the irritant limit R37 specified for that substance

is 1 or more, i.e.—

where—

PC. R35 is the percentage by volume of each corrosive substance to which is assigned the

risk phrase R35 in the preparation,

PC. R34 is the percentage by volume of each corrosive substance to which is assigned the


PXi R37 is the percentage by volume of each irritant substance to which is assigned the


LXi. R37 is the respective irritant limit R37 specified for each gaseous corrosive substance

to which is assigned the risk phrase R35 or R34 or gaseous irritant substance to

68

which is assigned the risk phrase R37, expressed as a percentage by weight or by

volume.

Classification by the conventional method as sensitising

12.—(1) The following preparations must be classified as sensitising by skin contact and

assigned the symbol “Xi”, the indication of danger “irritant” and risk phrase R43—

Preparations containing one or more substances classified as sensitising and to which is

assigned the risk phrase R43 that produces such effects in individual concentrations equal

to or exceeding—



(ii) the concentration specified in paragraph 5 of Part II of this Schedule (Table V or

Table VA) where the substance or substances do not appear in Table 3.2 part 3 of


(2) The following preparations must be classified as sensitising by inhalation and assigned the

symbol “Xn”, the indication of danger “harmful” and risk phrase R42—

Preparations containing one or more substances classified as sensitising and to which is

assigned the risk phrase R42 that produces such effects in individual concentrations equal

to or exceeding—



(ii) the concentration specified in paragraph 5 of Part II of this Schedule (Table V or

Table VA) where the substance or substances do not appear in Table 3.2 part 3 of


Classification by the convention method as carcinogenic

13.—(1) Preparations must be classified as carcinogenic category 1 or 2 and assigned the

symbol “T” and the risk phrase R45 or R49 if they contain one or more substance producing such

effects to which is assigned the risk phrase R45 or R49 which denotes carcinogenic substances in

category 1 and category 2 in individual concentrations equal to or exceeding—

(a) either the concentration specified in Table 3.2 part 3 of Annex VI of the CLP Regulation

for the substance or substances under consideration, or

(b) the concentration specified in paragraph 6 of Part II of this Schedule (Table V or Table

VA) where the substance or substances do not appear in Table 3.2 part 3 of Annex VI of

the CLP Regulation or appear in it without concentration limits.

(2) Preparations must be classified as carcinogenic category 3 and assigned the symbol “Xn” and

risk phrase R40 if they contain one or more substances producing such effects to which is assigned

the risk phrase R40 which denotes carcinogenic substances in category 3 in individual

concentrations equal to or exceeding—






Classification by the conventional method as mutagenic

14.—(1) Preparations must be classified as mutagenic category 1 or 2 and assigned the symbol

“T” and risk phrase R46 if they contain one or more substances producing such effects to which is

69

assigned the risk phrase R46 which denotes mutagenic substances in category 1 and category 2 in

individual concentrations equal to or exceeding—






(2) Preparations must be classified as mutagenic category 3 and assigned the symbol “Xn” and

risk phrase R68 if they contain one or more substances producing such effects to which is assigned

the risk phrase R68 which denotes mutagenic substances in category 2 in individual concentrations

equal to or exceeding—






Classification by the conventional method as toxic for reproduction

15.—(1) Preparations must be classified as toxic for reproduction category 1 or 2 and assigned

the symbol “T” and risk phrase R60 (fertility) if they contain one or more substances producing

such effects to which is assigned the risk phrase R60 which denotes substances toxic for

reproduction of category 1 and category 2 in individual concentrations equal to or exceeding—






(2) Preparations must be classified as toxic for reproduction category 3 and assigned the symbol

“Xn” and the risk phrase R62 (fertility) if they contain one or more substances producing such

effects to which is assigned the risk phrase R62 which denotes substances toxic for reproduction in

category 3 in individual concentrations equal to or exceeding—






(3) Preparations must be classified as toxic for reproduction category 1 or 2 and assigned the

symbol “T” and risk phrase R61 (development) if they contain one or more substances producing

such effects to which is assigned the risk phrase R61 which denotes substances toxic for

reproduction of category 1 and category 2 in individual concentrations equal to or exceeding—






(4) Preparations must be classified as toxic for reproduction category 3 and assigned the symbol

“Xn” and risk phrase R63 (development) if they contain one or more substances producing such

effects to which is assigned the risk phrase R63 which denotes substances toxic for reproduction in

category 3 in individual concentrations equal to or exceeding—



70




Classification of preparations by environmental hazards

16.—(1) The environmental hazards of a preparation must be assessed by one or more of the

following methods—

(a) by the conventional method described in the following paragraphs using concentration

limits; or

(b) by the criteria set out in the Approved Classification and Labelling Guide in relation to

the preparation for an appropriate classification and label.

(2) Where the environmental hazards have been established by both methods, the results of the

method set out in sub-paragraph (1)(b) must be used for classifying both the preparation.

(3) Subject to sub-paragraph (4), for preparations of a known composition, with the exception of

plant protection products, classified in accordance with the method set out in sub-paragraph (1)(b),

a new assessment of the environmental hazards must be performed either by the method set out in

sub-paragraph (1)(a) or (1)(b) whenever—

(a) changes of composition of the initial concentration, as a weight/weight or volume/volume

percentage, of one or more of the dangerous constituents are introduced by the

manufacturer which exceed the permitted variations set out in the following table—

Initial concentration range of the constituent Permitted variation in actual concentration of

the constituent

� 2.5% ± 30%

> 2.5 � 10% ± 20%

> 10 � 25% ± 10%

> 25 �100% ± 5%

(b) changes of composition involving the substitution or addition of one or more constituents,

which may or may not be dangerous within the definitions in Schedule 1, are introduced

by the manufacturer.

(4) The revised assessment required by paragraph (3) shall not be required where there is a valid

scientific justification for considering that a re-evaluation of the hazard will not result in a change

of classification.

Classification for environmental hazards by the conventional method

17.—(1) In accordance with paragraph 16(1)(a), the environmental hazards must be assessed by

the conventional method described below using concentration limits.

(2) Where the substances concerned are dangerous substances and are listed as dangerous

substances in Table 3.2 part 3 of Annex VI of the CLP Regulation and are assigned concentration

limits necessary for the application of the method of assessment described below, these

concentration limits must be used.

(3) Where the substances concerned are dangerous substances and do not appear in Table 3.2

part 3 of Annex VI of the CLP Regulation as dangerous substances or appear there without

concentration limits necessary for the application of the method of evaluation below, the

concentration limits must be assigned in accordance with Part II of this Schedule.

Conventional method for the evaluation of hazards to the aquatic environment

18.—(1) The following preparations must be classified as dangerous for the environment and

assigned the symbol “N”, the indication of danger “dangerous for the environment” and the risk

phrases R50 and R53 (R50-R53)—

71

(a) preparations containing one or more substances classified as dangerous for the

environment and to which is assigned phrases R50-R53 in individual concentrations equal

to or greater than—



(ii) the concentration specified in Part III of this Schedule (Table 1) where the substance

or substances do not appear in Annex VI of the CLP Regulation or appear in it

without concentration limits;

(b) preparations containing more than one substance classified as dangerous to the

environment and to which is assigned phrases R50-R53 in lower individual

concentrations than the limits specified under paragraph (a) if—

where—

PN. R 50-53 is the percentage by weight of each substance

dangerous for the environment to which is

assigned phrases R50-53 in the preparation,

LN. R 50-53 is the limit R50-53 for each substance


assigned the risk phrases R50-53 expressed as a

percentage by weight.

(2) The following preparations must be classified as dangerous for the environment and assigned

the symbol “N”, the indication of danger “dangerous for the environment” and risk phrases R51

and R53 (R51-R53) unless the preparation is already classified according to sub-paragraph (1)—


environment and to which is assigned phrases R50-R53 or R51-R53 in individual

concentrations equal to or greater than—







environment and to which is assigned phrases R50-R53 or R51-R53 in lower individual

concentrations than the limits specified under paragraph (a) if—

where—

72

PN. R 50-53 is the percentage by weight of each substance dangerous for the

environment to which is assigned phrases R50-53 in the preparation,

PN. R 51-53 is the percentage by weight of each substance dangerous for the


LN. R 51-53 is the respective limit R51-53 for each substance dangerous for the

environment to which is assigned the risk phrases R50-53 or R51-53

expressed as a percentage by weight.


the risk phrases R52 and R53 (R52-R53) unless the preparation is already classified according to

sub-paragraph (1) or (2)—


environment and to which is assigned phrases R50-R53 or R51-R53 or R52-53 in

individual concentrations equal to or greater than—




or substances do not appear in Table 3.2 part 3 of Annex VI of the CLP Regulation

or appear in it without concentration limits;


environment and to which is assigned phrases R50-R53 or R51-R53 or R52-53 in lower

individual concentrations than the limits specified under paragraph (a) if—

where—

PN. R 50-53 is the percentage by weight of each substance dangerous for the environment

to which is assigned phrases R50-53 in the preparation,

PN. R 51-53 is the percentage by weight of each substance dangerous for the environment


P R52-53 is the percentage by weight of each substance dangerous for the environment


L R52-53 is the respective limit R52-53 for each substance dangerous for the

environment to which is assigned the risk phrases R50-53, R51-53 or R52-53



the symbol “N”, the indication of danger “dangerous for the environment” and the risk phrase R50

unless the preparation is already classified according to sub-paragraph (1)—


environment and assigned phrase R50 individual concentrations equal to or greater

than—



73





environment and to which is assigned phrase R50 in lower individual concentrations than

the limits specified under paragraph (a) if—

where—

P R 50 is the percentage by weight of each substance dangerous for the

environment to which is assigned phrase R50 in the preparation,

LN. R 50 is the limit R50 for each substance dangerous for the environment to

which is assigned phrase R50 expressed as a percentage by weight.

(c) preparations containing one or more substances classified as dangerous to the

environment and to which is assigned phrase R50 not meeting the criteria under

paragraph (a) or (b) and containing one or more substances classified as dangerous to the

environment and to which is assigned phrases R50-53 if—

where—

P N. 50 is the percentage by weight of each substance


assigned phrase R50 in the preparation,

P N. R 50-53 is the percentage by weight of each substance


assigned phrases R50-53 in the preparation,

LN. R 50 is the respective limit R50 for each substance


assigned phrases R50 or R50-53 expressed as a

percentage by weight.


the risk phrase R52 unless the preparation is already classified according to sub-paragraph (1), (2),

(3) or (4)—


environment and to which is assigned phrase R52 in individual concentrations equal to or

greater than—



74


or substances do not appear in Table 3.2 part 3 of Annex VI of the CLP Regulation

or appear in it without concentration limits;




where—

P R52 is the percentage by weight of each substance dangerous for the environment

to which is assigned phrase R52 in the preparation,

L R52 is the limit R52 for each substance dangerous for the environment to which is

assigned phrase R52 expressed as a percentage by weight.


the risk phrase R53 unless the preparation is already classified according to sub-paragraph (1), (2)

or (3)—


environment and assigned phrase R53 in individual concentrations equal to or greater

than—









where—



LN. R 53 is the limit R53 for each substance dangerous for the environment to

which is assigned phrase R53 expressed as a percentage by weight.

(c) preparations containing one or more substances classified as dangerous to the

environment and to which is assigned phrase R53 not meeting the criteria under

paragraph (b) and containing one or more substances classified as dangerous to the

environment and to which is assigned phrases R50-53, R51-53 or R52-53 if—

75

where—



P N. R 50-53 is the percentage by weight of each substance dangerous for the


P N. R 51-53 is the percentage by weight of each substance dangerous for the

environment to which is assigned phrases R51-53 in the preparation

P R. 52-53 is the percentage by weight of each substance dangerous for the

environment to which is assigned phrases R52-53 in the preparation

L. R53 is the respective limit R53 for each substance dangerous for the

environment to which is assigned phrases R53, R50-53, R51-53 or R52-53


Conventional method for the evaluation of hazards to the ozone layer

19. Preparations containing one or more substances classified as dangerous for the environment

and to which is assigned the symbol “N” and the risk phrase R59 in individual concentrations

equal to or greater than—



(ii) the concentration specified in Part III of this Schedule (Table X) where the substance

or substances doe not appear in Table 3.2 part 3 of Annex VI of the CLP Regulation

or appear in it without concentration limits,

must be classified as dangerous for the environment and assigned the symbol “N”, the indication

of danger “dangerous for the environment” and the risk phrase R59.

Part II

CONCENTRATION LIMITS TO BE USED IN APPLYING THE

CONVENTIONAL METHOD OF ASSESSING HEALTH EFFECTS IN

ACCORDANCE WITH PART I OF THIS SCHEDULE WHERE NO SUCH LIMITS

ARE GIVEN IN TABLE 3.2 PART 3 OF ANNEX VI OF THE CLP REGULATION

An assessment must be made of the health effects that the use of a substance might entail. For that

purpose the dangerous health effects have been subdivided into:

1. acute lethal effects;

2. non-lethal irreversible effects after a single exposure;

3. severe effects after repeated or prolonged exposure;

4. corrosive effects, irritant effects;

5. sensitising effects;

6. carcinogenic effects, mutagenic effects, toxic effects for reproduction.

The systematic assessment of the dangerous health effects is expressed by means of

concentration limits, expressed as weight/weight percentage except for gaseous preparations

(Tables A) where they are expressed as a volume/volume percentage and in conjunction with the

classification of a substance.

76

The classification of the substance is expressed either by a symbol and one or more risk phrases

or by categories (category 1, category 2 or category 3) also expressed by risk phrases when

substances are shown to be carcinogenic, mutagenic or toxic for reproduction. Therefore it is

important to consider, in addition to the symbol, all the phrases denoting specific risks which are

assigned to each substance under consideration.

1. Acute lethal effects

1.1. Other than gaseous preparations

The concentration limits fixed in Table 1 determine the classification of the preparation in

relation to the individual concentration of the substance(s) present whose classification is also

shown.

Table I

Classification of the preparationClassification of

the substance T+ T Xn

T+ with R26,

R27, R28

concentration �7% 1% � concentration < 7% 0.1% � concentration < 1%

T with

R23, R24, R25

Concentration � 25% 3% � concentration < 25%

Xn with R20,

R21, R22

concentration � 25%

The R phrases denoting risk must be assigned to the preparation in accordance with the

following criteria—

(i) the label must include one or more of the above mentioned R phrases according to

the classification used,

(ii) in general, the R phrases selected should be those applicable to the substance(s)

present in the concentration which gives rise to the most severe classification.

1.2 Gaseous preparations

The concentration limits expressed as a volume/volume percentage in Table IA determine the

classification of the gaseous preparations in relation to the individual concentrations of the

gas(es) present whose classification is also shown.

77

Table IA

Classification of the preparationClassification

of the substance

(gas)T+ T Xn

T+ with

R26, R27, R28

concentration�1% 0.2% �concentration <1% 0.02%�concentration<0.2%

T with

R23, R24, R25

concentration � 5% 0.5%�concentration <5%

Xn with

R20, R21, R22

concentration �5%

The R phrases denoting risk must be assigned to the preparation in accordance with the

following criteria—

(i) the label must include on or more of the above mentioned R phrases according to the

classification used,

(ii) in general, the R phrases selected should be those applicable to the substance(s)

present in the concentration which gives rise to the most severe classification.

2. Non-lethal irreversible effects after a single exposure

2.1 Other than gaseous preparations

For substances that produce non-lethal irreversible effects after a single exposure (R39/route of

exposure. R68/route of exposure), the individual concentration limits specified in Table II

determine, when appropriate, the classification of the preparation.

Table II


of the substance T+ T Xn

T+ with

R39/ route of

exposure

concentration�10%

R39(*) obligatory

1% �concentration <10%

R39(*) obligatory

0.1%�concentration<1%

R68(*) (†) obligatory

T with R39/

route of

exposure


R39(*) obligatory

1%�concentration <10%

R68(*) (†) obligatory

Xn with R68/

route of

exposure

concentration �10%

R68(*)(†) obligatory

(*) In order to indicate the route of adminstration/ exposure the combined R phrases listed in Annex III of the Council Directive

67/548/EEC shall be used.

(†) R68 here refers to substances classifed as harmful. Concentration limits for substances required to be labelled R68 but

classified as mutagenic are given in Table VI.


78

For gases that produce non-lethal irreversible effects after a single exposure (R39/route of

exposure, R68/route of exposure), the individual concentration limits specified in Table IIA,

expressed as a volume/volume percentage, determine, when appropriate, the classification of the

preparation.

Table IIA


of the substance

(gas)T+ T Xn

T+ with

R39/ route of

exposure

concentration�1%

R39(*) obligatory

0.2% �concentration <1%

R39(*) obligatory

0.02%�concentration<0.2%


T with R39/

route of

exposure


R39(*) obligatory

0.5%�concentration <5%


Xn with R68/

route of

exposure

concentration �5%

R68 (*)(†) obligatory

(*) In order to indicate the route of adminstration/ exposure the combined R phrases listed in Part XXX of Annex VI of the CLP

Regulaton must be used.

(†) R68 here refers to substances classifed as harmful. Concentration limits for substances required to be labelled R68 but

classified as mutagenic are given in Table VI.

3. Severe effects after repeated or prolonged exposure


For substances that produce severe effects after repeated exposure (R48/route of exposure), the

individual concentration limits specified in Table III determine, when appropriate, the

classification of the preparation.

Table III


of the substance T Xn

T with R48/

route of

exposure


R48(*) obligatory

1%�concentration <10%

R48(*) obligatory

Xn with R48/

route of

exposure


R48(*)obligatory

(*) In order to indicate the route of adminstration/ exposure the combined R phrases listed in Annex III of Council Directive 67/548/EEC must be used.


For gases that produce severe effects after repeated or prolonged exposure (R48/route of

exposure), the individual concentration limits specified in Table IIIA, expressed as a

volume/volume percentage, determine, when appropriate, the classification of the preparation.

79

Table IIIA


of the substance

(gas)T Xn

T with R48/

route of

exposure

concentration �5%

R48(*) obligatory

0.5%�concentration <5%

R48(*) obligatory

Xn with R48/

route of

exposure

concentration �5%

R48(*)obligatory

(*) In order to indicate the route of adminstration/ exposure the combined R phrases listed in Annex III of Council Directive

67/548/EEC must be used.

4. Corrosive and irritant effects including serious damage to eye


For substances that produce corrosive effects (R34, R35) or irritant effect (R37, R37, R38, R41),

the individual concentration limits specified in Table IV determine, when appropriate, the


Table IV


of the

substanceC with R35 C with R34 Xi with R41 Xi with R36, R37,

R38

C with R35 concentration�10%

R35 obligatory

5%�concentration<

10%

R34 obligatory

5%(*) 1%�concentration

<5%

R35/38 obligatory


R34 obligatory

10%(*) 5%�concentration

<10%

R36/38 obligatory

Xi with R41 concentration�

10%

R41 obligatory

5%�concentration

<10%

R36 obligatory

Xi with R36,

R37, R38

concentration

�20%

R36, R37, R38 are

obligatory in the

light of the

concentration

present if they

apply to the

substances under

consideration

(*) According to the Approved Classification and Labelling Guide, when a substance or preparation is classified as corrosive and

assigned the risk phrase R34 or R35, the risk of severe damage to th eyes is considered implicit and the risk phrase R41 is not

included on the label. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concnetration

limits for a classificatio of the preparation as corrosive, such substances can contribute to a classification of the preparation (R41)

or irritiant (R36).

80

Note

Simple application of the conventional method to preparations containing substances classified as

corrosive or irritant may result in under-classification or over-classification of the hazard, if other

relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying

for corrosivity consider the advice given in the Approved Classification and Labelling Guide

regarding classification as corrosive and paragraph 4(4)(b) and (c) of Part I of this Schedule.


For gases that produce such effects (R34, R35 or R36, R37, R38, R41), the individual

concentration limits specified in Table IVA, expressed as a volume/volume percentage determine,

when appropriate the classification of the preparation.

Table IVA


of the

substance

(gas)

C with R35 C with R34 Xi with R41 Xi with R36, R37,

R38


R35 obligatory

0.2%�concentration<1%

R34 obligatory

0.2%(*) 0.02%�concentrati

on<0.2%

R36/37/38

obligatory


R34 obligatory

5%(*) 0.5%�concentratio

n<5%

R36/37/38

obligatory

Xi with R41 concentration�5%

R41 obligatory

0.5%�concentratio

n<5%

R36 obligatory

Xi with R36,

R37, R38

concentration �5%

R36, R37, R38 are

obligatory as

appropriate

(*) According to Annex VI of the CLP Regulation, when a substance or mixute is classified as corrosive and assinged the risk

phrase R34 or R35, the risk of severe damage to th eyes is considered implicit and the risk phrase R41 is not included on the

label. Consequently, if the preparation contains corrosive substances with R35 or R34 below the concnetration limits for a

classificatio of the preparation as corrosive, such substances can conctibute to a classifciaton of the mixcture (R41) or irritiatnd

(R36).

Note

Simple application of the conventional method to preparations containing substances classified as

corrosive or irritant may result in under-classification or over-classification of the hazard, if other

relevant factors (e.g. pH of the preparation) are not taken into account. Therefore, in classifying

for corrosivity consider the advice given in Annex VI of the CLP Regulation regarding

classification as corrosive and paragraph 4(4)(b) and (c) of Part I of this Schedule.

81

5. Sensitising effects


Preparations that produce such effects are classified as sensitising and assigned:

— the symbol Xn and phrase R42 if this effect can be produced by inhalation,

— the symbol Xi and phrase R43 if this effect can be produced through contact with the skin.

The individual concentration limits specified in Table V determine, when appropriate, the


Table V

Classification of the preparationClassification of the substance

Sensitising with R42 Sensitising with R43

Sensitising with R42 concentration �1%

R42 obligatory

Sensitising with R43 concentration �1%

R43 obligatory


Gases that produce such effects are classified as sensitising and assigned:

— the symbol Xn and phrase R42 if this effect can be produced by inhalation,

— the symbol Xi and phrase R43 if this effect can be produced through contact with the skin.

The individual concentration limits specified in Table VA expressed as a volume/volume

percentage, determine, when appropriate, the classification of the preparation.

Table VA

Classification of the gaseous preparationClassification of the substance (gas)

Sensitising with R42 Sensitising with R43

Sensitising with R42 concentration �0.2%

R42 obligatory

Sensitising with R43 concentration �0.2%

R43 obligatory

6. Carcinogenic/mutagenic/toxic effects for reproduction


For substances that produce such effects and for which specific concentration limits do not yet

appear in Table 3.2 part 3 of Annex VI of the CLP Regulation, concentration limits laid down in

Table VI shall determine, where appropriate, the classification of the preparation.

The following symbol and risk phrases are assigned:

82

Carcinogenic categories 1 and 2: T; R45 or R49

Carcinogenic category 3 Xn; R40

Mutagenic categories 1 and 2:T; T; R46

Mutagenic category 3: Xn R68

Toxic for reproduction fertility categories 1 and 2: T; R60

Toxic for reproduction development categories 1 and 2: T; R61

Toxic for reproduction fertility category 3 Xn; R62

Toxic for reproduction development category 3 Xn; R63

Table VI

Classification of the preparationClassification of the substance

Categories 1 and 2 Category 3

Carcinogenic substances of

category 1 or 2 with R45 or R49

Concentration � 0.1%

carcinogenic

R45, R49 obligatory as

appropriate


category 3 with R40

Concentration � 1%

carcinogenic

R40 obligatory (unless

already assigned R45(*)

)

Mutagenic substances of category

1 or 2 with R46


mutagenic

R46 obligatory

Mutagenic substances of category

3 with R68(**)


mutagenic

R68(**)

obligatory (unless

already assigned R46)

Substances “toxic for

reproduction” of category 1 or 2

with R60 (fertility)


toxic for reproduction

(fertility)

R60 obligatory


reproduction” of category 3 with

R62 (fertility)



(fertility)




reproduction” of category 1 or 2

with R61 (development)



(development)

R61 obligatory


reproduction” of category 3 with

R63 (development)



(development)


already assigned R61)(*)

In cases where the preparation is assigned R49 and R40, both R phrases must be kept,

because R40 does not distinguish between the exposure routes, whereas R49 is only assigned for

the inhalation route.(**)

R68 here refers to substances classified as mutagenic. Concentration limits for substances

required to be labelled R68 but classified as harmful are given in Table II.

83


For gases which produce such effects and for which specific concentration limits do not yet

appear in Table 3.2 part 3 of Annex VI of the CLP Regulation, concentration limits laid down in

Table VIA, expressed as a volume/volume percentage, shall determine, where appropriate, the


The following symbol and risk phrases are assigned:

Carcinogenic categories 1 and 2: T; R45 or R49

Carcinogenic category 3: Xn; R40

Mutagenic categories 1 and 2: T; R46

Mutagenic category 3: Xn R68

Toxic for reproduction fertility categories 1 and 2: T; R60

Toxic for reproduction development categories 1 and 2: T; R61

Toxic for reproduction fertility category 3: Xn; R62

Toxic for reproduction development category 3: Xn; R63

Table VIA

Classification of the gaseous preparationClassification of the substance

(gas) Categories 1 and 2 Category 3


category 1 or 2 with R45 or R49


carcinogenic

R45, R49 obligatory as

appropriate


category 3 with R40


carcinogenic


already assigned R45(*)

)

Mutagenic substances of category 1

or 2 with R46


mutagenic

R46 obligatory

Mutagenic substances of category 3

with R68(**)


mutagenic

R68(**)

obligatory (unless


Substances “toxic for reproduction”

of category 1 or 2 with R60

(fertility)



(fertility)

R60 obligatory


of category 3 with R62 (fertility)



(fertility)




of category 1 or 2 with R61

(development)



(development)

R61 obligatory


of category 3 with R63

(development)



(development)



84

(*) In cases where the preparation is assigned R49 and R40, both R phrases must be kept, because R40

does not distinguish between the exposure routes, whereas R49 is only assigned for the inhalation

route.(**)

R68 here refers to substances classified as mutagenic. Concentration limits for substances required

to be labelled R68 but classified as harmful are given in Table IIA.

PART III

CONCENTRATION LIMITS TO BE USED FOR THE EVALUATION OF

ENVIRONMENT HAZARDS

1. The aquatic environment

The concentration limits fixed in the following tables, expressed as a weight/weight percentage,

determine the classification of the preparation in relation to the individual concentration of the

substances present whose classification is also shown.

Table 1a

Acute aquatic toxicity and long-term adverse effects

Classification of the preparationClassification of the

substance N, R50-53 N, R51-53 R52-53

N, R50-53 see Table 1b see Table 1b see Table 1b

N, R51-53 Cn � 25% 2.5% � Cn < 25%

R52-53 Cn � 25%

For preparations containing a substance classified with N, R50-53, the concentration limits and

the resulting classification given in Table 1b are applicable.

Table 1b

Acute aquatic toxicity and long-term adverse effects of substance very toxic to the aquatic

environment

Classification of the preparationLC50 or EC50 value

(“L(E)C50”) of

substance classified

as N, R50-53 (mg/l)

N, R50-53 N, R51-53 R52-53

0.1 < L(E)C50 � 1 Cn � 25% 2.5% � Cn < 25% 0.25% � Cn < 2.5%

0.01 < L(E)C50 � 0.1 Cn � 2.5% 0.25% � Cn < 2.5% 0.025% � Cn <

0.25%

0.001 < L(E)C50 �

0.01

Cn � 0.25% 0.025% � Cn <

0.25%

0.0025% � Cn <

0.025%

0.0001 < L(E)C50 �

0.001

Cn � 0.025% 0.0025% � Cn <

0.025%

0.00025% � Cn <

0.0025%

0.00001 < L(E)C50 �

0.0001

Cn � 0.0025% 0.00025% � Cn <

0.0025%

0.000025% � Cn <

0.00025%

For preparations containing substances with a lower LC50 or EC50 value than 0.00001 mg/l, the

corresponding concentration limits are calculated accordingly (in factor 10 intervals).

85

Table 2

Acute aquatic toxicity

LC50 or EC50 value (“L(E)C50”) of

substance classified either as N, R50 or as

N,R50-53 (mg/l)

Classification of the preparation N, R50

0.1 < L(E)C50 � 1 Cn � 25%

0.01 < L(E)C50 � 0.1 Cn � 2.5%

0.001 < L(E)C50 � 0.01 Cn � 0.25%

0.0001 < L(E)C50 � 0.001 Cn � 0.025%

0.00001 < L(E)C50 � 0.0001 Cn � 0.0025%

For preparations containing substances with a lower LC50 or EC50 value than 0.00001 mg/l, the

corresponding concentration limits are calculated accordingly (in factor 10 intervals).

Table 3

Aquatic toxicity

Classification of the substance Classification of the preparation

R52

R52 Cn � 25%

Table 4

Long-term adverse effects

Classification of the substance Classification of the preparation

R53

R53 Cn � 25%

N, R50-53 Cn � 25%

N, R51-53 Cn � 25%

R52-53 Cn � 25%

2. The non-aquatic environment

The concentration limits fixed in the following table, expressed as a weight/weight percentage

or, for gaseous preparations as a volume/volume percentage, determine the classification of the

preparation in relation to the individual concentration of the substances present whose

classification is also shown.

Table 5

Dangerous for the ozone layer

Classification of the substance Classification of preparation N, R59

N with R59 Cn � 0.1%î

86

SCHEDULE 4 Regulations 3(2), 7 and 9

LABELLING PARTICULARS FOR DANGEROUS SUBSTANCES,

DANGEROUS PREPARATIONS AND FOR CERTAIN OTHER PREPARATIONS

PART 1

GENERAL PROVISIONS RELATING TO LABELS

Labelling particulars for dangerous substances

1.—(1) In the case of a dangerous substance which is listed in Table 3.2 part 3 of Annex VI of

the CLP Regulation, the particulars to be shown on the label in accordance with regulation 7(2)(c)

must be the particulars specified for that dangerous substance in the relevant entry in that table.

(2) Subject to paragraph 4, in the case of a dangerous substance which is not listed in Table 3.2

part 3 Annex VI of the CLP Regulation, the particulars required to be shown on the label in

accordance with regulation 7(2)(c) must be determined from the classification of the substance in

accordance with regulation 4 in conjunction with the Approved Classification and Labelling

Guide.

Labelling particulars for dangerous preparations

2.—(1) Subject to paragraphs 3 and 4, the provisions of this paragraph must have effect in

relation to the labelling of dangerous preparations.

(2) Subject to sub-paragraph (4), the particulars relating to the chemical name required to be

shown on the label in accordance with regulation 7(3)(c)(i) shall be shown according to the

following rules—

(a) in the case of a dangerous preparation classified as requiring the indication of danger T+,

T or Xn, only substances requiring those indications of danger present in the dangerous

preparation in concentrations equal to or greater than—

(i) the lowest limit (the Xn limit) for the substance laid down in Table 3.2 part 3 of

Annex VI of the CLP Regulation, or

(ii) where there is no such limit, the relevant limit laid down in Part II of Schedule 3,

have to be taken into consideration;

(b) in the case of a dangerous preparation classified as requiring the indication of danger C,

only substances requiring that indication of danger present in the dangerous preparation

in concentrations equal to or greater than—

(i) the lowest limit (the Xi limit) for the substance laid down in Table 3.2 part 3 of

Annex VI of the CLP Regulation, or

(ii) where there is no such limit, the relevant limit laid down in Part II of Schedule 3,

have to be taken into consideration;

(c) if the dangerous preparation is assigned one or more of the following danger categories:

— carcinogen category 1,2 or 3,

— mutagen category 1,2 or 3,

— toxic for reproduction category 1, 2 or 3,

— very toxic, toxic or harmful due to non-lethal effects after a single exposure,

— toxic or harmful due to severe effects after repeated or prolonged exposure,

— sensitising,

87

the name of any substance causing the dangerous preparation to be assigned shall be referred

to;

(d) as a consequence of the provisions set out in paragraphs (a) to (c), the name of any

substance which led to the classification of the dangerous preparation in the following

danger categories:

— explosive,

— oxidising,

— extremely flammable,

— highly flammable,

— flammable,

— irritant,

— dangerous for the environment,

need not be referred to on the label unless so required by paragraph (a), (b) or (c).

(3) The chemical name referred to in sub-paragraph (2) must be—

(a) in the case of a substance listed in Table 3.2 part 3 of Annex VI of the CLP Regulation,

the name or one of the names under which that substance is listed; or

(b) in the case of a substance not so listed, an internationally recognised name.

(4) For the purpose of labelling, no account shall be taken of a substance in the dangerous

preparation where the concentration of that substance is less than the concentration referred to in

paragraph 6 of Part 1 of Schedule 3.

(5) Subject to sub-paragraph (4), the particulars to be shown on the label in accordance with

regulation 7(3)(c)(i) shall be determined from the classification of the dangerous preparation made

in accordance with regulation 4 in conjunction with the Approved Classification and Labelling

Guide.

(6) As a general rule, a maximum of four chemical names shall suffice to identify the substances

primarily responsible for the major health hazards which have given rise to the classification and

the choice of the corresponding risk phrases-although in some cases more than four chemical

names may be necessary.

Confidentiality of chemical names

3.—(1) Subject to sub-paragraph (2), where the supplier of a dangerous preparation is able to

demonstrate to the Executive that the disclosure on the label or safety data sheet of the chemical

identity of a substance which is exclusively classified as—

(a) irritant with the exception of those assigned R41 or irritant in combination with one or

more of the other properties mentioned in paragraph (2)(2)(d); or

(b) harmful or harmful in combination with one or more of the properties mentioned in

paragraph (2)(2)(d) presenting acute lethal effects alone,

will put at risk the confidential nature of his intellectual property, the person must, in accordance

with the provisions of Annex VI of Council Directive 1999/45/EEC, be permitted to refer to that

substance either by means of a name that identifies the most important functional chemical groups

or by means of an alternative name.

(2) The derogation in sub-paragraph (1) shall not apply in respect of a substance which has been

assigned a Community exposure limit.

(3) Where a supplier wishes to take advantage of the derogation contained in sub-paragraph (1),

he shall make application to the Executive accordingly, enclosing the information specified in

Annex VI of Council Directive 1999/45/EEC.

(4) The Executive may require such further information from the supplier as is necessary to

determine the validity of an application made under sub-pargraph (3).

88

Indications of danger and symbols for dangerous substances and dangerous preparations

4.—(1) Except in the case of dangerous substance which is listed in Table 3.2 part 3 of Annex

VI of the CLP Regulation, where a dangerous substance or dangerous preparation is required to

have more than one indication of danger in either of the following groups listed in decreasing

order of severity, namely—

(a) explosive, oxidising, extremely flammable and highly flammable; or

(b) very toxic, toxic, corrosive, harmful and irritant,

only one of the indications of danger with its symbol from each group corresponding to the most

severe indication of danger in that group need be shown.

(2) The risk phrases R 12 (extremely flammable) and R 11 (highly flammable) need not be used

if they repeat the indication of danger shown on the label.

PART II

PARTICULAR PROVISIONS CONCERNING CERTAIN PREPARATIONS

A

SPECIAL PROVISIONS FOR DANGEROUS PREPARATIONS

Dangerous preparations to be supplied to the general public

1.—(1) The label on the packaging of dangerous preparations intended to be supplied to the

general public must in addition to the relevant safety advice bear the relevant safety phrase S1, S2,

S45 or S46 in accordance with the approved classification and labelling guide.

(2) When the dangerous preparations referred to in sub-paragraph (1) are classified as very

toxic, toxic or corrosive and where it is physically impossible to give the information on the

package itself, packages containing such preparations must be accompanied by precise and easily

understandable instructions for use including, where appropriate, instructions for the destruction of

the empty package.

Dangerous preparations intended for use by spraying

2. The label on the packaging containing dangerous preparations intended to be used for

spraying shall bear the safety phrase S23 and safety phrase S38 or S51 assigned in accordance

with the approved classification and labelling guide.

Dangerous preparations containing a substance affected by the risk phrase R33 (danger of

cumulative effects)

3. When a dangerous preparation contains at least one substance required to show the risk phrase

R33, that phrase must be shown on the label on the packaging of the dangerous preparation when

the concentration of that substance is equal to or higher than 1% unless a different value is shown

for that substance in Table 3.2 part 3 of Annex VI of the CLP Regulation.

Dangerous preparations containing a substance affected by the risk phrase R64 (may cause

harm to breast-fed babies)

4. When a dangerous preparation contains at least one substance required to show the risk phrase

R64, that phrase must be shown on the label on the packaging of the dangerous preparation when

the concentration of that substance is equal to or higher than 1% unless a different value is shown

for that substance in Table 3.2 part 3 of Annex VI of the CLP Regulation.

89

B

SPECIAL PROVISIONS APPLYING TO ANY PREPARATION

Paints and varnishes containing lead

1.—(1) The label on the packaging of paints and varnishes containing lead in quantities

exceeding 0.15% (expressed as weight of lead out of the total weight of the preparation and

determined in accordance with ISO Standard 6503/1984) shall bear the following inscription–

ìContains lead. Should not be used on surfaces that are liable to be chewed or sucked by

children.î.

(1) In the case of packages containing less than 125 millilitres of the preparations referred to in

sub-paragraph (1), the inscription on the label may be–

ìWarning! Contains lead.î.

Cyanoacrylate based adhesives

2.—(1) The label on the immediate packaging of glues based on cyanoacrylates shall bear the

following inscription–

ìCyanoacrylate.

Danger.

Bonds skin and eyes in seconds.

Keep out of the reach of children.î.

(1) Appropriate safety advice shall accompany the package.

Preparations containing isocyanates

3. The label on the packaging of preparations containing isocyanates (whether as monomers,

oligomers, prepolymers etc. or as preparations thereof) shall bear the following inscriptions–

ìContains isocyanates.

See information supplied by the manufacturer.î.

Certain preparations containing epoxy constituents

4. The label on the packaging of preparations containing epoxy constituents with an average

molecular weight �700 shall bear the following inscription–

ìContains epoxy constituents.

See information supplied by the manufacturer.î.

Preparations intended to be sold to the general public that contain active chlorine

5. The label on the packaging of preparations containing more than 1% of active chlorine which

are intended to be sold to the general public shall bear the following inscription–

ìWarning! Do not use together with other products. May release dangerous gases (chlorine).î.

Preparations containing cadmium (alloys) intended to be used for brazing or soldering

6. The label on the packaging of preparations containing cadmium (alloys) intended to be used

for brazing or soldering shall bear the following inscriptions–

90

ìWarning! Contains cadmium.

Dangerous fumes are formed during use.

See information supplied by the manufacturer.

Comply with the safety instructions.î.

Preparations not classified as sensitising but containing at least one sensitising substance

7. The label on the packaging of preparations containing at least one substance classified as

sensitising and being present in a concentration �0.1% or in a concentration greater than or equal

to that specified under a specific note for the substance in Table 3.2 part 3 of Annex VI of the

CLP Regulation must bear the inscription–

ìContains (name of sensitising substance). May produce an allergic reaction.î.

Liquid preparations containing halogenated hydrocarbons

8. For liquid preparations which show no flashpoint or a flashpoint higher than 55°C and contain

a halogenated hydrocarbon and more than 5% flammable or highly flammable substances, the

label on the packaging must bear the following inscription as appropriate–

ìCan become highly flammable in use.î or

ìCan become flammable in use.î.

Preparations containing a substance assigned the risk phrase R67

9. When a preparation contains one or more substances assigned the risk phrase R67, the label

on the packaging of the preparation must bear the following inscription–

ìVapours may cause drowsiness and dizzinessî,

when the total concentration of such substances present in the preparation is �15%, unless:

— the preparation is already classified with phrases R20, R23, R26, R68/20, R39/23 or

R39/26, or

— the preparation is in a package not exceeding 125 ml.

Cement and cement preparations

10.—(1) The label on the packaging of any cement or cement preparation which would contain,

when hydrated, more than 0.0002% soluble chromium (VI) of the total dry weight of the cement

but for the use of reducing agents shall be marked with information on the packing date, and on

the storage conditions and the storage period appropriate to maintaining the activity of the

reducing agent and to preventing the content of soluble chromium (VI) from exceeding 0.0002%

of the total dry weight of the cement, unless it is supplied or used for controlled, closed and totally

automated processes in which cement and cement-containing preparations are handled solely by

machines and in which there is no possibility of contact with the skin.

(2) The label on the packaging of any cement or cement preparation containing more than

0.0002% soluble chromium (VI) of the total dry weight of the cement must bear the inscription:

ìContains chromium (VI). May produce an allergic reaction.î

unless the preparation is already classified and labelled as a sensitiser with phrase R43.

91

C

SPECIAL PROVISIONS APPLYING TO CERTAIN OTHER PREPARATIONS

Preparations not intended for the general public

11. The label on the packaging of a preparation of the type specified in regulation 5(3) must bear

the following inscription—

ìSafety data sheet available for professional user on request.”.

SCHEDULE 5 Regulation 12

BRITISH STANDARDS RELATING TO CHILD RESISTANT

FASTENINGS AND TACTILE WARNING DEVICES

The British Standards and International Standards referred to in regulation 12 are as follows—

“BS EN 28317” means the British Standard Specification for packagings resistant to opening by

children, BS EN 28317: 1993 which was published by the British Standards Institution and came

into effect on 15 February 1993;

“ISO 8317” means the International Standard ISO 8317 (1 July 1989 edition) relating to “Child-

resistant packagings- Requirements for the testing of reclosable packages” adopted by the

International Standards Association;

“BS 6652” means the British Standard Specification for packagings resistant to opening by

children, BS 6652: 1989 which was published by the British Standards Institution and came into

effect on 30 June 1989;

“EN 862” means the CEN standard EN 862 (March 1997 edition) relating to “Packaging – Child-

resistant packaging-Requirements and testing procedures for non-reclosable packages for non-

pharmaceutical products” adopted by the European Committee for Standardisation;

“EN ISO 11683” means the EN ISO Standard 11683 (1997 Edition) relating to “Packaging –

Tactile warnings of danger – Requirements.”;

“BS 7501” means the British Standard on the general criteria for the operation of testing

laboratories BS 7501: 1989 which was published by the British Standards Institution and came

into effect on 31 October 1989;

“EN 45 000” means the European Standards Series 45 000 which sets out the general criteria

which laboratories must adhere to in order to obtain accreditation for the certification of child

resistant fastenings.

The full text of this and other Consultative Documents can be viewed and downloaded from the Health and Safety Executive web site on the internet: www.hse.gov.uk/consult/index.htm

Printed and published by the Health and Safety Executive

© Crown copyright 2008 12/08

Proposals for the Chemical (Hazard Information and Packaging for Supply) Regulations 2009 – CHIP 4


CD220

www.hse.gov.uk