TBT, SPS, The New Approach and Technical Regulations with Reference to the Food Sector

1
TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• EU Technical Regulation Schemes in the EU
• The primary objective is to eliminate barriers to
  trade between member states by eliminating
  differences in national law
• We shall discuss 2 schemes
• The New Approach Laws
• Food Law

2
TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach
• The New Approach is more practical way of
  Regulating and
• Harmonising laws for products.
• The new approach is designed to harmonize the
  health, safety, and environmental requirements of
  the Member States
• Regulation is limited to the Essential Health
  and Safety
• Requirements
• It is directed regulating families of products
  rather than single products.
• The New Approach includes the Global Approach
  which establishes common criteria for Conformity
  Assessment Procedures. These are included in
  New Approach directives.

3
TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach -Regulation is limited to the
  Technical
• Regulation specifying Essential Health and
  Safety Requirements
• The Technical Regulations are designed to
  protect the public the heart in relation to
  Health, Safety and the Environment
• The Technical Regulations are mandatory and are
  rigidly enforced
• The Technical Regulations must be applied as a
  function of the hazards inherent to a given
  product.
• Products must comply with these Technical
  Regulations before they are placed on the market
• The Technical regulation sare listed in the Annex
  to the Directives
• Products may have to comply with a number of New
  Approach Directives before they may be placed on
  the market.

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TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach-Essential Health and Safety
  Requirements
• Designed to protect the public interest health
  and safety of users (consumers and workers),
  protection of property and the environment
• The Technical Regulations must be applied as a
  function of the hazards inherent to a given
  product.
• Manufacturers need to carry out risk analysis to
  determine the essential requirement applicable to
  the product
• The Technical Regulations governing the Essential
  Requirements define the results to be attained,
  or the hazards to be dealt with
• They Technical Regulations do not specify the
  technical solutions for doing so.

5
TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach-Essential Health and Safety
  Requirements
• The Technical Regulations define
• The hazards to be dealt with, for example
  physical and mechanical resistance, flammability,
  chemical, electrical or biological properties,
  hygiene, radioactivity, accuracy),
• OR
• The results to be attained (for example in terms
  of performance provisions regarding materials,
  design, construction, manufacturing process,
  instructions drawn up by the manufacturer),
• OR
• Lay down the principal protection objective (for
  example by means of an illustrative list).

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TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach - Conformity Assessment
  Procedures
• Before placing the product on the market the
  manufacturer must demonstrate that the product
  complies with the technical regulations in the
  relevant New Approach directives.
• Each New Approach Directive lists the Conformity
  Assessment
• Procedures or Modules that may be employed by
  the manufacturer to
• demonstrate compliance.
• Generally there are eight basic modules can be
  combined in a number of ways
• Manufacturers may choose between different
  conformity
• assessment procedures provided for in the
  applicable directive

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TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach 8 Basic Conformity Assessment
  Modules
• Internal Control of Production No Notified Body
  Certification
• EC type-examination. Design Phase, must be
  followed up by a module Production Phase.
  Notified Body issues Certificate
• Conformity to Type. Production Phase.Follows B.
  Conformity with EC type-examination certificate
  issued in B. No further Notified Body
• Certification
• Production Quality Assurance. Follows B. Derives
  from quality assurance standard EN ISO 9002.
  Notified Body is responsible for approving and
  controlling the quality system for production.
  Final product inspection and testing set up by
  the manufacturer.

8
TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach 8 Basic Conformity Assessment
  Modules
• Product Quality Assurance. Production Phase.
  Follows B. Derives from quality assurance
  standard EN ISO 9003. Notified Body responsible
  for Final Product Inspection and Testing
• Product Verification Production Phase Follows
  B. Notified Body controls conformity to the type
  according to EC Certificate issued in B, and
  issues a Certificate of Conformity
• Unit verification. Design and Production Phases.
  Each individual product is examined by a Notified
  Body, which issues a Certificate of Conformity.
• Full Quality Assurance. Design and Production
  Phases. Derives from quality assurance standard
  EN ISO 9001. Notified Body responsible for
  approving and controlling the quality system for
  design, manufacture, final product inspection and
  testing.

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TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach - Conformity Assessment
  Procedures
• Harmonised Standards and the Presumption of
  Conformity
• The Technical Regulations set out in the New
  Approach directives may be set down in
  harmonised standards or European standards.
  These standards are mandated by the EU and
  prepared by European standards organisations.
• Products manufactured in compliance with
  harmonised standards are assumed to conform
  with the Technical Regulations in the New
  Approach Directives.
• The application of these or standards remains
  voluntary, and the manufacturer may always apply
  other technical specifications to meet the
  requirements.

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TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach
• CE MARKING
• The CE marking on a product confirms
• That product complies with the Technical
  Regulations in the New
• Approach Directives and
• The appropriate conformity assessment procedures
  have been
• completed
• The CE Marking is placed on the product by the
  manufacturer
• The CE Marking when required by the New Approach
  Directives is mandatory

11
TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach -Technical Documentation
• The manufacturer must draw up an EC declaration
  of conformity as part of the conformity
  assessment procedures.
• This should include
• A reference to the relevant directives,
• Name and address of manufacturer, representative,
  and notified body
• Description of the the product,
• A reference to harmonised standards or
• Any other normative documents.

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• The New Approach -Technical Documentation
• The EC declaration of conformity must be made
  available to the Market Surveillance Authority on
  request.
• Under some New Approach Directives it is
  mandatory thatproducts are accompanied by the EC
  declaration of conformity.

13
TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach
• Notified Bodies
• The New Approach Directives require Governments
  to appoint Notified Bodies to carry the
  conformity assessment procedures listed in the
  directives

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TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach - Notified Bodies
• Notified Bodies are appointed on the basis of an
  assessment which determines if the Notified Body
  is technically competent and capable of carrying
  out the conformity assessment procedures in
  question, and if it can demonstrate the necessary
  level of independence, impartiality and
  integrity.
• In practice most EU Member States assign the
  assessment of Notified Bodies to an National
  Accreditation Body

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TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach - Notified Bodies
• Notified Bodies may offer their conformity
  assessment services to any company in the EU or
  in Third countries
• Manufacturers are free to choose any Notified
  Body
• NotifiedBodies may be
• Laboratories
• Calibration centres
• Inspection centres
• Testing centres

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TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach - Market Surveillance
• Market Surveillance State Supervision-Enforcement
  
• The New Approach Directives require Governments
  to appoint Market Surveillance authorities to
  check for compliance with the New Approach
  Directives and to take action to remove products
  from the market that are not in compliance.

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TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach - Market Surveillance
• Governments generally assign responsibility for
  Market Surveillance to the relevant Ministries
  with the expertise relevant to the areas covered
  by the New Approach Directive or create separate
  agencies such
• Consumer Protection Agency
• Food Safety Authority
• Notified Bodies may not be used for market
  surveillance activities in order to avoid
  conflicts of interest

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TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach Market surveillance
• Market surveillance operations takes place only
  the products have been place on the market.
• Efficient enforcement usually requires that the
  Market Surveillance authorities act in
  collaboration with manufacturers and suppliers in
  order to prevent the placing on the market of
  non-compliant products
• Market Surveillance Authorities work closely with
  the Customs Authorities

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TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach Accreditation Bodies
• EU Member States assign the assessment of
  Notified Bodies to an National Accreditation Body
• National Accreditation Bodies use the relevant
  International Organisation for Standardisation
  ISO 17000 series of standards and guides and the
  harmonised EN 45000 series of European standard
  to assess the capacity of the Notified Body to
  carry out the relevant conformity assessment
  procedures

20
TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach Accreditation Bodies
• The EN 45000 standards consist, in general terms,
  of
• A part dealing with the organisation and
  management of the body, and
• A part dealing with the technical requirements
  relating to the operation of the body.
• The standards must be seen as an integral whole,
  since both parts are needed to ensure the
  reliability and capability of the operations of
  the conformity assessment bodies.

21
TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach - Multilateral Recognition
  Agreements
• The New Approach directives provides for
  recognition of Third Country Conformity
  assessment procedures where Mutual Recognition
  Agreements are established between the EU and
  the Third country.
• Mutual Recognition Agreements are based on the
  mutual acceptance by the EU and the Third Country
  of certificates, marks of conformity and test
  reports issued by the conformity assessment
  bodies in each country.
• The EU negotiates Mutual Recognition Agreements
  with Third Countries which have a comparable
  level of technical development and similar
  conformity assessment procedures.

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TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach - Multilateral Recognition
  Agreements
• Multilateral Recognition Agreements are also
  provided for in the legislation. These are mutual
  recognition negotiated on a multilateral basis
• Two accreditation associations facilitate MLAs
• European Accreditation Organisation (EA)
• International Accreditation Forum (IAF)

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TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• The New Approach - Mutual Recognition Agreements
• The key benefit of Mutual Recognition is that it
  eliminates the need for suppliers of products or
  services to submit their products to conformity
  assessment procedures in each country. A
  conformity assessment procedure can be carried
  out in the exporting country and it is recognised
  in each country who is a party to the agreement
• This helps eliminate Technical Barriers to Trade

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TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• Multilateral Recognition Agreements (MLAs)

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TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• TBT National infrastructure for Non-Food
  products
• Government Ministries Responsible for
• Drafting Regulations
• Appointment of Notified Bodies
• Market Surveillance -Enforcement of Regulations

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TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• TBT National infrastructure for Non-Food
  products
• National Standards Agencies
• National Accreditation Body
• National Standards Body
• National Metrology Body

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TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• TBT National infrastructure for Non-Food
  Products
• Notified Bodies
• Laboratories
• Calibration centres
• Inspection centres
• Testing centres

28
TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector
The Infrastructure in Member States for the
Implementation and of Technical Regulations in
the EU
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TBT, SPS, The New Approach and Technical
Regulations with Reference to the Food Sector

• In the EU the management infrastructure designed
  to enforce technical standards and conformity
  assessment procedures under TBT is different to
  the management infrastructure designed to
  enforce sanitary and phytosanitary measures under
  SPS