Week 4 Flashcards
What was the problem with the traditional approach?
- Slow and cumbersome legislative process
- Outdated results
- Problematic implementation
What are the characteristics of the New Approach?
- Legislative acts per…
- Restricted to …
- Technical specification reserved for …
- Powers delegate to …
- QMV
- Legislative act per product category and
risk type (horizontal approach) - Legislative acts restricted to setting
essential requirements - Technical specification reserved for
standards set by ESOs + Presumption of
conformity - More powers delegated to the Commission + Comitology
- After SEA. art. 100A (now 114 TFEU),
qualified majority
Why the “Global Approach” arised?
After Casis de Dijon:
Insufficient to create the necessary level of trust between MS.
The “New Approach” introduced earlier was insufficient for building this trust.
Thus, the Global Approach was developed, emphasizing a horizontal conformity assessment policy to address this gap.
What are the Standards?
- Normative documents
- With prescriptions
- Address risks based on the relevant state of art
- Are elaborated in a standardisation process
Are developed to align with the essential requirements set out in EU harmonization legislation
What is the difference between EU standard and harmonized standard?
- EU standard is descripted by a body.
- EU harmonized standard is adopted as a result of a Commission’s request.
What are the European Standardisation Organisations (ESOs)?
- Are Key bodies responsible for standardization in the EU, including CEN, CENELEC, and ETSI.
- These organizations operate under private law, as clarified in James Elliott Construction (C-613/14).
What is the New Legislative Framework?
- Builds on the “New Approach” and “Global Approach”
- but refines them into the more comprehensive New Legislative Framework.
It has a key regulation:
- Decision 768/2008/EC: Establishes a common framework for marketing products.
- Regulation 765/2008/EC: Outlines requirements for accreditation and market surveillance.
What is the process under the New Legislative Framework? 8 Steps
8 steps
Step 1: The Essential Requirements.
What, How, Where, Relevant actors?
What: Are prescriptions for broad product categories, classified by risk types (safety, health, and environmental concerns).
They should be sufficiently clear, precise, and implementable to allow compliance and conformity assessment.Yet, underlying technology neutrality.
How: Ordinary legislative procedure
Where?: Legislative act (Directive or Regulation) published in OJEU
Relevant actors?: Commission + EP and Council
b. The
Commission’s
Request
What is, What is it effect, How is it implemented, Why is it published?
Standardisation Regulation (SR): The Commission may request to ESOS to draft a European Standard.
What is? Is a formal document motivation, legal basis and description of the deliverables
What is it effect? The validity of deliverables and the interpretation.
How is it implemented? follows Comitology procedures
Published: The implemented decision is published as Implementing Decisions in the Official Journal of the European Union (OJEU).
Step 3: The ESOS acceptance, how is this process?
The ESOs must respond in 1 month if accepts the request. If accepts, must require funds to the Commission
Step 4: Draft
Standards.
What and how?
Drafts which compliance is not compulsory, on the basis of a request made by the Commission for the application of Union
harmonisation legislation.
How? Standardisation by CEN, CENELEC or ETSI following the Comission’s request
Step 5: Ex ante Compliance Assessment
- The ESOS shall inform the Commission for the devolpment of the drafts.
- The Commission with the ESOS shall assess the compliance of the documents drafted by the European standardisation organisations with its initial request.
Step 6: What Does Publication of References Mean?
When a harmonized standard satisfies the requirements outlined in the relevant EU harmonization legislation, the European Commission is required to publish a reference to that standard in the Official Journal of the European Union (OJEU).
Step 6: Publication of References. How is it done and where is published?
- The publication of references follows the comitology process
- The reference to the harmonized standard is published in an Implementing Decision in the Official Journal of the European Union (OJEU).
Only the reference (not the full standard text).
Step 6: What is the effect of the Publication?
- Voluntary in Principle.
- Presumption of Conformity:
Products complying with harmonized standards are presumed to meet the requirements of the relevant EU legislation (Article 3(2) of Decision 768/2008/EC) - National Standardization Bodies (NSBs) are required to repeal any conflicting national standards (Article 3(6) of the Standardisation Regulation).
Step 7: Conformity assessment
Is the process of ensuring that products meet the required standards and regulations for safety, health, and environmental protection before entering the market. There are three types:
Step 7: Conformity assessment. What are the types?
- Self-assessment: by manufacturer or an independent department of the manufacturer
- Assessment by notified bodies: A third-party organization (notified body) evaluates the product. This is typically required for higher-risk products like medical devices.
- Assessment by public authorities: Direct involvement of public authorities to ensure compliance. This is less common and usually applies to very specific regulatory scenarios.
Ex Post Accountability Mechanisms.
How is the judicial review in the context of harmonized standards?
Judicial Review
1. The Court of Justice of the European Union (CJEU) has the authority to interpret harmonized standards.
2. Legal Basis: Article 267 TFEU, as demonstrated in the case C-613/14 James Elliott Construction.
Limitations:
3. The CJEU cannot determine the validity of harmonized standards under Article 263 or Article 267 TFEU.
It can only assess the validity of Commission Implementing Decisions, not the standards themselves.
If the CJEU invalid the implementing decision the standard is still there but is not harmonised anymore.
Ex Post Accountability Mechanisms.
How is the political and administrative control?
- ‘Political’ Control: formal objection by EP or Member
States (previously Commission, but not anymore), art.
11 Standardisation Regulation. - Administrative Control: market surveillance by
designated national authorities, see Regulation
Regulation (EU) 2019/1020 and the relevant
harmonisation legislation
Are voluntary standards?
- Presumption of conformity
- De facto mandatory
- Presumption of Conformity:
Standards provide the presumption of compliance with EU legislation, enabling products to circulate freely in the internal market.
They specify rights and obligations and are necessary for implementing EU law (e.g., James Elliott Construction and Public.Resource.Org cases).
- De Facto Mandatory: Due to the lack of alternatives and the costs/time involved in proving compliance otherwise, standards are considered de facto mandatory (Fra.bo and Public.Resource.Org).
Restricted Access to Standards?
- Access to Standards
- Are Standards Freely Accessible?
- Copyright and Funding
- Access to Standards: Standards can typically be accessed via licenses from National Standardization Bodies (NSBs), except ETSI. Access depends on national arrangements and is linked to copyright protection.
- Are Standards Freely Accessible?: Cases (Stichting Rookpreventie and Public.Resource.Org) suggest they should be, but the extent of this accessibility is unclear—whether it entails free access to content or just limited access rights.
- Copyright and Funding: Copyright concerns raise financial implications for the EU. The Commission has allocated grants to create accessibility rooms, emphasizing access without compromising copyright protection.
Participation and Representativeness
- Representation in Standardization: Article 5 and 6 of the Standardization Regulation require efforts to include Annex III organizations, but:
- These organizations have no decision-making powers.
- Their insufficient participation doesn’t affect the validity of harmonized standards but may influence funding arrangements (Article 17(5) Standardization Regulation).
Sufficient Accountability?
- Ex Ante Compliance Control: Standards proposed by ESOs (European Standardization Organizations) may lack sufficient preemptive control.
- Conformity Assessment: Primarily performed by notified bodies or through self-assessment, which raises concerns about conflicts of interest.
- Solutions: Ensure self-assessment is limited to low-risk cases, liability legislation, and challenges to notified body competence.
- Limits of Accountability: Resources and the need to prioritize limit the ability to ensure full accountability.
Delegation?
- Delegation of Regulatory Powers: The delegation of regulatory powers to private bodies is lawful if the delegation is limited and subject to control (Meroni and ESMA cases).
- Broad Discretion: The EU legislature can refer to technical standards by private bodies but must distinguish between essential requirements and technical specifications (Stichting Rookpreventie case).
- Privacy Concerns: Delegation can be problematic for fundamental rights, such as standards related to privacy.
