CHEMICALS

1
CHEMICALS

• Regulations and Directives applying in the
  European Union

2
CHEMICALS

• OBJECTIVE
• Two key pieces of EU legislation aim to achieve
• High level of protection of human health and the
  environment from chemicals

3
CHEMICALS

• OBJECTIVE
• Producers of chemicals are required
• a) to identify intrinsic hazards of the chemicals
  they manufacture OR import
• b) to label these chemicals according to strict
  rules and
• c) to package them safely.

4
CHEMICALS

• Dangerous substances directive
• Prime aim
• Identify
• Control
• Communication of principal hazards
• Classification
• Labeling
• Risk phrases
• Icons

5
CHEMICALS

• Dangerous substances directive
• may recommend certain packaging precautions
• depending on the hazard properties of a substance
  

6
CHEMICALS

• Dangerous Substances Directive
• 67/548/EEC as amended for the seventh time by
  92/32/EEC
• For the purposes of this Directive
• (a) "substances" means chemical elements and
  their compounds in the natural state or obtained
  by any production process, including any additive
  necessary to preserve the stability of the
  products 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
• (b) "preparations" means mixtures or solutions
  composed of two or more substances

7
CHEMICALS

• Dangerous Substances Directive
• Sets out to harmonised European Union rules for
• Classification
• Packaging and
• Labelling
• of dangerous chemical substances.

8
CHEMICALS

• Dangerous Substances Directive
• According to Article 2 of this Directive, the
  following substances (and preparations) are
  dangerous
• (a) explosive substances and preparations
• (b) oxidising substances and preparations
• (c) extremely flammable substances and
  preparations
• (d) highly flammable substances and preparations

9
CHEMICALS

• Dangerous Substances Directive
• Article 2 (contd.)
• (e) flammable substances and preparations
• (f) very toxic substances and preparations
• (g) toxic substances and preparations
• (h) harmful substances and preparations
• (i) corrosive substances and preparations
• (j) irritant substances and preparations

10
CHEMICALS

• Dangerous Substances Directive
• Article 2 (contd.)
• (k) sensitizing substances and preparations
• (l) carcinogenic substances and preparations
• (m) mutagenic substances and preparations
• (n) substances and preparations which are toxic
  for reproduction
• (o) substances and preparations which are
  dangerous for the environment

11
CHEMICALS

• Dangerous Preparations Directive
• Directive 1999/45/EC
• The scope of the previous directive was extended
  to include for the FIRST TIME pesticides
• And to include a requirement to classify and
  label preparations for environmental hazards.

12
CHEMICALS

• Dangerous Preparations Directive
• 1999/45/EC
• This Directive aims at the approximation of the
  laws, regulations and administrative provisions
  of the Member States relating to
• the classification, packaging and labelling of
  dangerous preparations, and to
• the approximation of specific provisions for
  certain preparations which may present hazards,
  whether or not they are classified as dangerous
  within the meaning of this Directive,
• when such preparations are placed on the market
  of the Member States.

13
CHEMICALS

• Dangerous Preparations Directive
• Classification as in Annex VI of 67/548/EEC
• General concentration limits (Annex I to
  67/548/EEC)
• self-classification (Article 6 of 92/32/EEC)

14
CHEMICALS

• Labelling- Danger Symbols

15
CHEMICALS

• Labelling Risk Safety phrases
• R-phrases
• Risks arising from dangers using the substance
• S-phrases
• Safety requirements
• Emergency response procedures

16
CHEMICALS

• Labelling Risk Safety Phrases
• 68 different Risk phrases
• Also combination of some of these phrases
• 64 safety phrases
• Some phrases can be combined

17
CHEMICALS

• Substances and Preparations Directives
• These two Directives only concern the assessment
  of INTRINSIC hazards for chemicals.

18
CHEMICALS

• Substances and Preparations Directives
• Exclusions from the scopes of these Directives
  include
• (a) medicinal products for human or veterinary
  use, as defined in Directive 65/65/EEC
• (b) cosmetic products as defined in Directive
  76/768/EEC
• (c) mixtures of substances which, in the form of
  waste, are covered by Directives 75/442/EEC(14)
  and 78/319/EEC
• (d) foodstuffs
• (e) animal feedingstuffs
• (f) preparations containing radioactive
  substances as defined by Directive 80/836/Euratom

19
CHEMICALS

• Substances and Preparations directives
• Also excluded are
• the carriage of dangerous preparations by rail,
  road, inland waterway, sea or air,
• preparations in transit which are under customs
  supervision, provided they do not undergo any
  treatment or processing.

20
CHEMICALS

• Harmonised Legislation
• Article 95 of the Treaty of Rome
• Commission informed of national requirements
• Six-month consideration period

21
CHEMICALS

• Special chemicals
• Directive 1999/45/EC extended the scope of the
  dangerous preparations directive to include, for
  the first time, pesticides.
• Pesticides are still subject to the requirements
  of Directive 91/414/EEC concerning the placing of
  plant protection products on the market.

22
CHEMICALS

• Special chemicals
• Biocides are subject to the requirements of the
  Directive 98/8/EC concerning the placing of
  biocidal products on the market.

23
CHEMICALS

• EINECS
• This is the acronym for the European INventory of
  Existing commercial Chemical Substances.
• Similar function to the widely-used Chemical
  Abstract Number (CAS) system.

24
CHEMICALS

• EINECS (contd.)
• lists and defines those chemical substances,
  which were deemed to be on the European Community
  market between 1 January 1971 and 18 September
  1981
• In terms of Article 1(4) of the amended Directive
  67/548, these are substances to which the
  pre-marketing notification provisions of the
  Directive do not apply.
• Any chemical substance which has been marketed
  after 18 September, 1981 is called a new chemical
  

25
CHEMICALS

• ELINCS
• New substances/chemicals form a cumulative index,
  European List of Notified Chemical Substances
  (ELINCS)
• Periodically updated in Official Journal
• Exemptions include consumer products pertaining
  to pharmaceuticals, cosmetics foodstuffs
• Excluded are pesticides, radioactive materials,
  wastes, and substances used in scientific
  research.

26
CHEMICALS

• ELINCS (contd.)
• Notification Dossier
• Identity of notifier/manufacturer
• Identity of chemical substance (e.g. CAS number)
• Production process
• Proposed uses
• Results from analysis of chemical physical
  properties
• Test reports from toxicological and
  ecotoxicological assays

27
CHEMICALS

• ELINCS (contd.)
• Notification dossier (contd.)
• Proposals for classification labelling
• Including recommended precautions regarding
  safety
• Drafted risk assessment
• Dossier detail increases according to substance
  quantity, viz 10kg, 100kg, 1000kg per year per
  manufacturer
• amounts exceeding 100 tonnes and 1000 tonnes
  require further toxicological and
  ecotoxicological testing

28
CHEMICALS

• ELINCS (contd.)
• Notification dossier (contd.)
• This dossier should be submitted to the national
  Competent Authority
• A list of these Authorities is available on the
  following Web page
• http//ecb.jrc.it/DOCUMENTS/New-Chemicals/Notifica
  tion_units.pdf
• Competent Authority evaluates dossier
• Forward to the European Chemicals Bureau (ECB)

29
CHEMICALS

• ELINCS (contd.)
• Maintained in English only
• Published on ECB Website
• Via link on http//ecb.jrc.it/new-chemicals/

30
CHEMICALS

• Registry number
• Applies to existing and new substances
• Seven digit format
• NNN-NNN-N
• Distinction between EINECS ELINCS
• Check digit
• EC number

31
CHEMICALS

• Substances and Preparations Directives
• Safety Data Sheets (SDS)
• Directives 67/548/EEC and 1999/45/EC (
  corrigendum) require producers of dangerous
  chemicals to provide industrial and professional
  users with detailed health, safety and
  environmental information and advice about their
  products in the form of safety data sheets.

32
CHEMICALS

• Safety Data Sheets (contd)
• Directive 91/155/EEC, as amended by Directives
  93/112/EEC and Directive 2001/58/EC, sets out the
  requirements for the information which should be
  included in a safety data sheet.

33
CHEMICALS

• Safety Data Sheets (contd)
• The main purpose of safety data sheets is to
  enable employers to determine whether any
  hazardous chemicals are present in the workplace,
  and to assess whether there is any risk to the
  health and safety of workers and/or to the
  environment arising from their use.

34
CHEMICALS

• Safety Data Sheets (contd)
• Data must be entered under 16 headings. These
  are
• 1. Identification of the substance/preparation
  and of the company/undertaking
• 2. Composition/information on ingredients
• 3. Hazards identification
• 4. First aid measures
• 5. Fire-fighting measures
• 6. Accidental release measures
• 7. Handling and storage
• 8. Exposure controls/personal protection
• 9. Physical and chemical properties
• 10. Stability and reactivity
• 11. Toxicological information
• 12. Ecological information
• 13. Disposal considerations
• 14. Transport information
• 15. Regulatory information
• 16. Other information

35
CHEMICALS

• Safety Data Sheets (contd.)
• Council Directive 98/24/EC of 7 April 1998 on the
  protection of the health and safety of workers
  from the risks related to chemical agents at work
  sets out employers responsibilities in detail.

36
CHEMICALS

• Developments
• Directive 1999/45/EC will most probably be
  revised together with the Directive 67/548/EEC in
  the regime of the implementation of GHS and the
  REACH legislation.

37
CHEMICALS

• GHS
• Globally Harmonized System of Classification and
  Labelling of Chemicals
• Globally harmonized system to address
  classification of chemicals, labels, and safety
  data sheets.
• Link with UNCEDTG having harmonized system for
  physical hazards and acute toxicity in the
  transport sector.

38
CHEMICALS

• GHS
• The current document comprises over two hundred
  pages of text with nine annexes.
• In excess of 400 pages in total.
• The document can be viewed via links from the
  following web page
• http//www.unece.org/trans/danger/publi/ghs/ghs_re
  v00/00files_e.html

39
CHEMICALS

• GHS (contd.)
• Part 1 Introduction includes
• Definitions and abbreviations
• Classification of hazardous substances and
  mixtures
• Hazard communication labelling
• Hazard communication safety data sheets

40
CHEMICALS

• GHS - Hazard Communication Labelling
• Symbols to be used

41
CHEMICALS

• GHS (contd.)
• Symbols to be used (contd.)

42
CHEMICALS

• GHS (contd.)
• Symbols to be used (contd.)

43
CHEMICALS

• GHS (contd.)
• Symbols to be used (contd.)

44
CHEMICALS

• GHS Hazard Communication SDS
• Format
• SDS information is to be presented using the
  following 16 headings
• 1. Identification
• 2. Hazard(s) identification
• 3. Composition/information on ingredients
• 4. First-aid measures
• 5. Fire-fighting measures
• 6. Accidental release measures
• 7. Handling and storage
• 8. Exposure controls/personal protection

45
CHEMICALS

• GHS SDS
• Format (contd.)
• 9. Physical and chemical properties
• 10. Stability and reactivity
• 11. Toxicological information
• 12. Ecological information
• 13. Disposal considerations
• 14. Transport information
• 15. Regulatory information
• 16. Other information.

46
CHEMICALS

• GHS (contd)
• Implementation into EU legislation
• Replace provisions on classification and
  labelling given in 67/548/EEC and 1999/45/EC as
  amended

47
CHEMICALS

• REACH
• Proposal for a regulation concerning the
  Registration, Evaluation, Authorisation and
  Restriction of Chemicals
• Manufacture or import of more than one tonne per
  year
• Registration in a central database

48
CHEMICALS

• REACH (contd.)
• Aims
• To improve protection of human health and the
  environment
• Maintain competitiveness
• Enhance innovative capability
• Requires new chemicals agency

49
CHEMICALS

• REACH (contd.)
• Final adoption expected end of 2006
• Entry into force around April 2007
• European Chemical Agency operational 12 months
  later

50
CHEMICALS

• REACH (contd.)
• European Chemicals Agency
• Independent
• HQ in Helsinki, Finland
• To manage and (some times) carry out technical,
  scientific and administrative aspects
• To provide advice

51
CHEMICALS

• REACH (contd.)
• Assessment of substances
• Preparation of chemical safety reports
• Information required based on annual production
  or importation
• Levels set at 1, 10, 100, 1000 tonnes
• Standard testing regime relating to information
  required

52
CHEMICALS

• REACH (contd.)
• Some other aspects covered by REACH
• Downstream users
• Criteria for identification of substances that
  are
• Persistent very persistent
• Bio-accumulative very bio-accumulative
• Toxic.
• Lists of substances subjected to authorisation
• Restrictions on manufacture, placing on market
  and use
• Persistent organic pollutants (POP)

53
CHEMICALS

• REACH (contd.)
• Manufacturers of or importers of one tonne or
  more of a chemical substance per year would be
  required to register it in a central database.

54
CHEMICALS
55
CHEMICALS

• International Agreements

56
INTERNATIONAL AGREEMENTS

• PIC Procedure
• Regulation EC 304/2003 implements the Rotterdam
  Convention on Prior Informed Consent, the 'PIC
  procedure.
• Importing countries may refuse or apply
  conditions to import of certain dangerous
  chemicals.
• Improves information exchange on banned chemicals
  or those subject to severe restrictions.

57
INTERNATIONAL AGREEMENTS

• PIC (contd.)
• Regulation EC 304/2003 requires
• Mandatory notification for all exports of
  chemicals banned or whose use is severely
  restricted in the EU
• Chemicals to be exported at least six months
  prior to their expiry date
• Exports to countries outside of the EU are
  packaged and labelled to at least the standard
  applied in the EU

58
INTERNATIONAL AGREEMENTS

• PIC (contd.)
• Substances that are banned for use within the
  Community are forbidden from being exported to
  countries outside of the Community.

59
INTERNATIONAL AGREEMENTS

• PIC (contd.)
• Notification procedure
• The chemicals subject to the Regulations are
  listed in three parts of Annex I
• Part I identifies chemicals that are banned or
  severely restricted in the EU for health or
  environmental protection reasons and are thus
  subject to notification.
• Part II identifies chemicals that qualify for PIC
  notification and import consent.
• Part III identifies chemicals subject to the full
  PIC procedure.

60
INTERNATIONAL AGREEMENTS

• PIC (contd.)
• The first export outside the EC of a chemical, or
  a preparation containing one or more chemicals
  listed in Part I, has to be notified (at least 30
  days in advance) to the Designated National
  Authority of the exporter's own country.
  Thereafter the first export in each calendar year
  must be notified at least 15 days before the
  export takes place.

61
INTERNATIONAL AGREEMENTS

• PIC (contd.)
• Chemicals listed in Part II III are subject to
  the full export procedure including obtaining
  consent by the importing country, providing the
  use category and providing any additional
  information required by the importing authority.

62
INTERNATIONAL AGREEMENTS

• PIC (contd.)
• The National Authority sends the information to
  the European Commission to allocate a unique
  reference number to the export . The export
  reference number must be included in the
  documents for all subsequent exports of the
  chemical to the importing country during the
  calendar year . The EC provides the importing
  authority with a summary of information on the
  substance.

63
INTERNATIONAL AGREEMENTS

• PIC (contd.)
• Can be found at the following Web page
• http//ecb.jrc.it/edex/en/

GUIDE TO REGULATION (EC) OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL No 304/2003
CONCERNING THE EXPORT AND IMPORT OF DANGEROUS
CHEMICALS
64
INTERNATIONAL AGREEMENTS

• Persistent Organic Pollutants
• POP
• Powerful pesticides
• Highly toxic
• Persistent, lasting for years (or even decades)
  before degrading
• Evaporate and disperse long distances through air
  and water
• Accumulate in fatty tissue

65
INTERNATIONAL AGREEMENTS

• Persistent Organic Pollutants - POP
• Stockholm Convention on Persistent Organic
  Pollutants
• Targeted 12 particularly toxic POPs
• reduction
• Eventual elimination

66
INTERNATIONAL AGREEMENTS

• POP
• The Convention
• Entered into force 17 May 2004
• gt 90 countries had joined by April 2005

67
INTERNATIONAL AGREEMENTS

• POP
• Five essential aims
• 1. Eliminate dangerous POPs
• Starting with the 12 worst
• 2. Support the transition to safer alternatives
• 3. Target additional POPs for action
• 4. Clean up old stockpiles and equipment
  containing POPs
• 5. Work together for a POP-free future

68
INTERNATIONAL AGREEMENTS

• POP
• UNEP
• The United Nations Environment Programme has
  published a guide on the Stockholm Convention.
• This Guide can be located at
• http//www.pops.int/documents/guidance/beg_guide.p
  df

69
CHEMICALS

• UK Implementation

70
UK IMPLEMENTATION

• UK Regulations
• Enforcement
• The manufacturer/supplier is responsible for
• The correct classification, labelling and
  packaging of individual chemicals
• The notification of new chemicals, including the
  risk assessment (optional) 

71
UK IMPLEMENTATION

• UK Regulations
• Two regulations enforce the manufacturer/supplier
  obligations
• Classification/labelling/packaging
• CHIP regulations
• Notification of new chemicals
• NONS regulations

72
UK - CHIP

• UK
• Dangerous Substances and Preparations
• CHIP Regulations
• This stands for the Chemicals (Hazard Information
  and Packaging for Supply) Regulations 2002
• Statutory Instrument 2002 No. 1689
• Applies to England, Scotland and Wales
• In Northern Ireland there are Chemicals Hazard
  Information and Packaging for Supply Regulations
  (Northern Ireland) 2002
• Statutory Instrument 2002 No. 301

73
UK - CHIP

• CHIP implements three European Union (EU)
  Directives
• the Dangerous Substances Directive (DSD)
• the Dangerous Preparations Directive (DPD) and
• the Safety Data Sheets Directive (SDSD).

74
CHEMICALS

• UK CHIP Regulations
• Proposal for 30th ATP to the DSD
• Proposal developed with industry participation
• UK industry invited to comment on the impact of
  proposed changes to its business, its customers
  and its specific market sector.
• Comments relating to costs and benefits
  associated with the changes

75
UK - CHIP

• Enforcement
• Industrial HSE Inspectors
• Retail premises Local Trading Standards
  Officers

76
UK - CHIP

• Enforcement (contd.)
• HSE enforces health and safety legislation for
  some industry sectors in the UK - excluding those
  enforced by Local Authorities.
• factories, building sites, mines, farms,
  fairgrounds, quarries, railways, chemical plants,
  offshore and nuclear installations, schools,
  hospitals and some other places where there is a
  work activity.

77
UK - CHIP

• Enforcement (contd.)
• HSE Inspectors offer advice on how to comply with
  the law
• Order people to make improvements by issuing them
  with a notice
• Improvement Notice giving time for compliance
• Prohibition Notice prohibiting activity until
  remedial action taken
• Issue notices for breaches of health and safety
  law

78
UK - CHIP

• Enforcement (contd.)
• Prosecution for failure to comply with a Notice
• No standard tariffs for offences
• No further action taken for non-compliance to a
  Notice
• Depends upon circumstances
• HSE will continue to monitor and enforce

79
UK - CHIP

• Enforcement (contd.)
• Trading Standards monitor consumer goods placed
  on the UK market
• Act where incidents have occurred
• Act when complaints are issued regarding safety
  of products
• No formal inspection/acceptance procedure for
  products entering the UK market

80
UK - CHIP

• Enforcement (contd.)
• Trading Standards
• Will provide clear understanding of what needs to
  be done and by when
• Give time to rectify the non-compliance, unless
  immediate action is needed
• Will inform people/businesses of their rights to
  appeal

81
UK - NONS

• What are the regulations?
• NONS 93 implement Directive 92/32/EEC
• Known as seventh amendment to Dangerous
  Substances Directive 67/548/EEC
• Notification requirements same for all Member
  States
• Notification accepted in one Member State is
  valid in all member States

82
UK - NONS

• PRODUCT CONTROL UK
• Notification of New Substances Regulations
• Issued in 1993
• NONS 93
• European-wide system
• Suppliers must get information on substances new
  to the European market
• Information used to assess whether or not the
  substance is dangerous
• Applies to manufacturers and importers

83
UK - NONS

• New Substances
• Annex I to the DSD is transposed in GB by the
  Health Safety Commission's (HSC) Approved
  Supply List (ASL).

84
UK - NONS

• To whom do they apply?
• any person who supplies a new substance either as
  such or contained in a preparation
• This includes selling it, lending it to someone
  else, passing it on, giving it away or importing
  it into the EC.

85
UK - NONS

• Who is responsible for the regulations?
• Competent Authority (CA)
• Health Safety Executive (HSE)
• Environmental Agency (EA)

86
UK - NONS

• Functions of the CA
• The key functions of the CA are
• evaluating notification dossiers
• providing a risk assessment
• requiring additional information from notifiers
  where necessary
• advising on interpretation of the Seventh
  Amendment Directive and NONS 93
• co-operating with other Member State CAs
• co-operating with the European Commission (CEC)

87
UK - NONS

• Notifying Substances
• Why notify?
• Legal requirement
• Supplier obliged to ensure information available
  to minimise risks to people, general public and
  the environment
• Practical and financial benefits to (potential)
  suppliers of chemicals to a European market.

88
UK - NONS

• Notifying Substances (contd.)
• When is a Notification Required?
• When placed on the market
• Supplying a substance or preparation
• Making a substance available to another person
• Includes importation

89
UK - NONS

• Notifying Substances (contd.)
• Notification levels
• Charge made and content of test package
  proportional to the level of supply
• Levels are based on annual supply and cumulative
  supply
• Once supply has breached the upper limit for the
  annual or cumulative quantity, notification must
  be upgraded to next level.

90
UK - NONS

• - Notifying substances (contd.)

Type of Notification Annual Quantity Cumulative Quantity
Level 2 (1000 t) 1000 t 5000 t
Level 1 (100 t) 100 t 500 t
Level 1 (10 t) 10 t 50 t
VII A 1 t 5 t
VII B 100 kg and lt 1 t 500 kg
VII C 10 kg and lt 100 kg lt 500 kg
91
UK - NONS

• Notifying substances (contd.)
• Where is the notification made?
• EU manufacturers Member State in which it is
  made
• Importers into the EU Member State in which
  they are established
• Non-EU manufacturers having appointed a sole
  representative should notify the country in
  which this representative is established.

92
UK - NONS

• Notifying substances (contd.)
• How much does it cost?
• Cost proportional to the notification level
• Costs cover appraisal of notification package
• Additional fee can be levied for conducting the
  risk assessment
• Companies providing adequate risk assessment are
  not charged
• Full list of charges may be found at the
  following web page
• http//www.hse.gov.uk/nons/Nons9.htm