PURPOSE: to align Directive 2009/23/EC on the
harmonisation of the laws of the Member States relating to making
available on the market of non-automatic weighing instruments with
the new legislative framework, in particular to Decision No
768/2008/EC establishing a common framework for the marketing of
products (Goods Package).
PROPOSED ACT: Directive of the European Parliament and
of the Council.
BACKGROUND: experience with the implementation of
Union harmonisation legislation has shown – on a cross-sector
scale – certain weaknesses and inconsistencies in the
implementation and enforcement of this legislation, leading
to:
- the presence of non-compliant or dangerous products on
the market and consequently a certain lack of trust in CE
marking;
- competitive disadvantages for economic operators
complying with the legislation as opposed to those circumventing
the rules;
- unequal treatment in the case of non-compliant
products and distortion of competition amongst economic operators
due to different enforcement practices;
- differing practices in the designation of conformity
assessment bodies by national authorities;
- problems with the quality of certain notified
bodies.
To remedy these horizontal shortcomings in Union
harmonisation legislation observed across several industrial
sectors, the “New Legislative Framework” was
adopted in 2008 as part of the goods package. Its objective is to
strengthen and complete the existing rules and to improve practical
aspects of their application and enforcement. The New Legislative
Framework (NLF) consists of two complementary instruments,
Regulation (EC) No 765/2008 on accreditation and market
surveillance and Decision No 768/2008/EC establishing a common
framework for the marketing of products.
This proposal on the harmonisation of the laws of the
Member States relating to making available on the market of
non-automatic weighing instruments is presented in the framework of
the implementation of the “goods package” adopted
in 2008. It is part of a package of proposals aligning ten product
directives to Decision No 768/2008/EC establishing a common
framework for the marketing of products.
IMPACT ASSESSMENT: based on the information collected,
the Commission carried out an impact assessment which examined and
compared three options:
- Option 1 – No
changes to the current situation;
- Option 2 –
Alignment to the NLF Decision by non-legislative
measures;
- Option 3 –
Alignment to NLF Decision by legislative measures: this option
consists in integrating the provisions of the NLF Decision into the
existing directives.
Option 3 was found to be the preferred
option for the following reasons: (i)
it will improve the competitiveness of companies and notified
bodies taking their obligations seriously, as opposed to those
cheating on the system; (ii) it will improve the functioning of the
internal market by ensuring equal treatment of all economic
operators, notably importers and distributors, as well as notified
bodies; (iii) it does not entail significant costs for economic
operators and notified bodies; (iv) it is considered more effective
than option 2: due to the lack of enforceability of option 2 it is
questionable that the positive impacts would materialise under that
option.
LEGAL BASIS: Article 114 of the Treaty on the
Functioning of the European Union (TFEU).
CONTENT: the alignment to the NLF Decision requires a
number of substantive amendments to the provisions of Directive
2009/23/EC. To ensure the readability of the amended text, the
technique of recasting has been chosen. The proposal does
not change the scope of Directive 2009/23/EC and the essential
requirements.
The main elements of the proposal are as
follows:
- Horizontal definitions:
the proposal introduces harmonised definitions of terms which are
commonly used throughout Union harmonisation legislation and should
therefore be given a consistent meaning throughout that
legislation.
- Obligations of economic operators and traceability
requirements: the proposal clarifies
the obligations of manufacturers and introduces obligations for
importers and distributors. Importers must verify that the
manufacturer has carried out the applicable conformity assessment
procedure and has drawn up a technical documentation. They must
also make sure with the manufacturer that this technical
documentation can be made available to authorities upon request.
Furthermore importers must verify that the instruments are
correctly marked and accompanied by instructions and safety
information. They must keep a copy of the Declaration of conformity
and indicate their name and address on the product, or where this
is not possible on the packaging or the accompanying documentation.
Distributors must verify that the article bears the CE marking, the
name of the manufacturer and of the importer, if relevant, and that
it is accompanied by the required documentation and
instructions.
- Harmonised standards:
compliance with harmonised standards provides a presumption of
conformity with the essential requirements. On 1 June 2011 the
Commission adopted a proposal for a Regulation on European
Standardisation that sets out a horizontal legal
framework for European standardisation. The proposal for the
Regulation contains inter alia provisions on standardisation
requests from the Commission to the European Standardisation
Organisations, on the procedure for objections to harmonised
standards and on stakeholder participation in the standardisation
process. Consequently, the provisions of Directive 2009/23/EC which
cover the same aspects have been deleted in this proposal for
reasons of legal certainty. The provision conferring presumption of
conformity to harmonised standards has been modified to clarify the
extent of the presumption of conformity when standards only
partially cover the essential requirements.
- Conformity assessment and CE marking: Directive 2009/23/EC on the placing on the market of
pyrotechnic articles has selected the appropriate conformity
assessment procedures which manufacturers have to apply in order to
demonstrate that their pyrotechnic articles comply with the
essential safety requirements. The proposal aligns these procedures
to their updated versions set out in the NLF Decision.
- Notified Bodies: the
proposal reinforces the notification criteria for notified bodies.
It clarifies that subsidiaries or subcontractors must also comply
with the notification requirements. Specific requirements for
notifying authorities are introduced, and the procedure for
notification of notified bodies is revised. The competence of a
notified body must be demonstrated by an accreditation
certificate.
- Market surveillance and the safeguard clause
procedure: the proposal revises the
existing safeguard clause procedure. It introduces a phase of
information exchange between Member States, and specifies the steps
to be taken by the authorities concerned, when a non-compliant
instrument is found.
BUDGETARY IMPLICATIONS: this proposal does not have
any implications for the EU budget.