Freedom of Movement of Technical Goods

• Structure of CE Marking legislation
• What are the three Brexit agreements
• Immediate effect of Brexit on EU law
• Differences between CE and UKCA
• Marking
• Northern Ireland and UKNI

The Structure of the CE Marking Legislation

• Article 100A of Treaty of Rome – 1992
• New approach directives (indirect effect)
• Safety legislation
• Conformance Assessment and Essential Requirements
• (Mostly) self certification – Declaration of Compliance
• Cumulative legislation – Examples

Interaction with Standards

• But, in practice ISA, IEC, ITU
• Conformance Assessment
• CE Marking entirely based on standards
• EU standards, international standards,
• national standards – How many EU standards needed?
• Based on (published) European
• Harmonised Standards (CEN, CENELEC; ETSI)
• Now (in UK) BSI standards most relevant
• Membership of CEN, CENELEC, ETSI

What are the Brexit Agreements

• Withdrawal Agreement of 24 January 2020 between EU and UK
• Agreement between Iceland, Liechtenstein and Norway (UK and EU) of 28 January 2020
• Trade and Cooperation Agreement of 25 December 2020 between EU and UK
• Not a “Comprehensive Economic and Trade Agreement” with Member States
• Enforcement issue, because may not directly bind a (member) state

Immediate Effect of a “Hard” Brexit

• A “Hard Brexit”: no transition or other arrangements
• Existing law applies
• Authorised Representative – If not appointed => importer into EEA

Nothing Has Changed Everything Has Changed Interpretation

• Why most European Law is now irrelevant
• 60% law is European law
• Interpretation on a European basis – The European Court of Justice
• Significance of official languages

Why was the European Position Relevant?

• Interpretation on a European basis
• The European Court
• Defence to a prosecution
• Position if national law is not the same
• Francovitch – sue government for damages!
• Importance of decisions in other states
• The UK Court now ignore EU interpretations

Metrification and Brexit

• No transition or other arrangements – Except for 2 pages of GDPR
• SI 696/19: The Product Safety and
• Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019
• Hard Brexit => existing law applies
• Concept of an “authorised representative” – Compare GDPR
• Authorised Representative, importer
• Concepts of “Notified Body”, “First Use”

First Use in EEA Machine Safety Directive

• Phrase used is “placed on the market … or put into service”
• “‘placing on the market’ means making available
• for the first time in the [EEA]
• [machinery or partly completed machinery]
• with a view to distribution or use,
• whether for reward or free of charge”
• “ ‘putting into service’ means the first use,
• for its intended purpose, in the [EEA]
• of [machinery] covered by this Directive
• Essentially same under Medical Device Directive

First Use in EEA Toy Safety Directive

• Phrase used is (only) “placed on the market”
• ‘placing on the market’ means
• “the first making available of a toy
• on the [EEA] market”

First Use in EEA: EMC Directive

• Phrase used is “placed on the market … or making available on the market”
• ‘placing on the market’ means
• “the first making available of apparatus
• on the [EEA] market”
• ‘making available on the market’ means “any supply of apparatus
• for distribution or use on the [EEA] market
• in the course of a commercial activity,
• whether in return for payment or free of charge;”

First Use in EEA: EMC Regulation

• Phrase used is “placed on the market … or making available on the market”
• ‘placing on the market’ means
• “the first making available of apparatus
• on the [EEA] market”
• ‘making available on the market’ means “any
• supply of apparatus
• for distribution, consumption or use on the [EEA] market
• in the course of a commercial activity,
• whether in return for payment or free of charge;”

First Use in EEA: General Effect of Directives

• Words used are not retrospective – Article 40 of EFTA Agreement: burden of proof
• But meaning differs between countries
• “Supply” example
• Ireland (and UK): extends to “offering or
• exposing for sale or inviting an offer to purchase”
• Netherlands: exact words of Directive

Obligations of Individual Users

• “Put into service”
• EMC example
• A person must not make equipment available on the market or put equipment into service unless it complies with the essential requirements ” UK
• A person shall not … put into service equipment … unless the equipment concerned meets the essential requirements ” Ireland

EMC and Safety

• TFEU Article 114
• Includes freedom of movement of goods
• Concerning health, safety, environmental protection and consumer protection
• EU position (is and was) safety related
• Under UK law
• Original (1992) position of DTI
• Current position of Department for Business, Energy & Industrial Strategy
• Actual UK legal position

Authorised Representative in EEA

• “ ‘authorised representative’ means any natural or legal person
• established in the Community who has received [and accepted]*
• written mandate from the manufacturer
  – “to perform on his behalf all or part of the obligations and formalities connected with this Directive” (Machine)
  – “to act on his behalf in relation to specified tasks” (Toy Safety, Medical Devices, EMC – Directives
• *Not in EMC Directive
  

Northern Ireland Protocol

• Part of the Withdrawal Agreement
• Provisions of Protocol
• Apply “to and in the United Kingdom [but only] in respect of Northern Ireland” Article 5 (4)
• Annex 2 to Protocol includes:
  – General Product Safety Directive
  – CE Marking legislation

Northern Ireland 1

• Goods manufactured in Northern Ireland
• Manufacturers based in NI continue to follow the CE Marking regime
• Manufacturer can just design and apply his trade mark
• Must apply the CE Marking
• Choice
• Use a UK Notified body
• Use an EU Notified body
• Can always then import from NI into GB

Northern Ireland 2

• Where a UK Notified body carries out
• conformity assessment:
  – Must apply CE Marking
  – Also apply UKNI Marking
• Cannot sell into the EEA
• Where an EU Notified body carries out conformity assessment
  – Use (only) CE Marking
  – Guarantee of unfettered access

Northern Ireland 3

• But excludes EU recognition of “technical regulations, assessments, registrations, certificates, approvals and authorisations” by UK or UK bodies
• Authorised representative for NI cannot be in GB
• Authorised representative in NI cannot act for EEA?
• UK Guidance ambiguous because refers to
  “[EMC] regulations as they apply to NI”

Northern Ireland 4

• Gaming the system
• Northern Ireland manufacturers have unfettered access
• Includes a subsidiary / sister company who “designs and owns the trade mark”
• But “longer term qualifying regime in the course of 2021, with only businesses established in Northern Ireland benefitting from unfettered access”
• But need separate product traceability