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Second quarterly Newsletter: Comitology

Legal Acts in the EU in the area of technical harmonization: adopted or proposed during the second quarter of 2010

 

    Comitology

 

 

COMITOLOGY - REGULATORY PROCEDURE WITH SCRUTINY

 

 

Contrary to the provisions of the Treaty establishing the European Community (hereafter "the EC Treaty"), set out in Article 202 thereof, the new Treaty makes a clear distinction between the powers delegated to the Commission to adopt non-legislative acts of general application to supplement or amend certain non-essential elements of a legislative act (delegated acts) on the one hand and the powers conferred on the Commission to adopt implementing acts on the other hand. They are subject to entirely different legal frameworks::

  • The provisions of the new Treaty on delegated acts, which are set out in Article 290 of the Treaty on the Functioning of the European Union (hereinafter "the Treaty"), provide for the legislator to control the exercise of the Commission's powers by means of a right of revocation and/or a right of objection. These provisions are sufficient in themselves and do not require any legally binding framework to make them operational.

  • The provisions of the new Treaty on implementing acts, which are set out in Article 291, do not provide any role for the European Parliament and the Council to control the Commission's exercise of implementing powers. Such control can only be exercised by the Member States. A legal framework is required to establish the mechanisms of such control.

 

Proposal - name

Information

Discussion state

REACH

1. Draft Commission Regulation (EC) No …/.. of […] amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII

Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations established in its Annex I restrictions for certain dangerous substances and preparations. Regulation (EC) No 1907/2006 repeals and replaces Directive 76/769/EEC with effect from 1 June 2009. Annex XVII to that Regulation replaces Annex I to Directive 76/769/EEC

27. 3. 2009
29. 4. 2009
11. 5. 2009
26. 6. 2009

WP Coreper
Education, Youth and Culture Council
OJ EU L 164

2. Draft Commission Regulation (EC) No …/.. of amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (dichloromethane, lamp oils and grill lighter fluids and organostannic compounds)

Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations established in its Annex I restrictions for certain dangerous substances and preparations. Regulation (EC) No 1907/2006 repealed and replaced Directive 76/769/EEC with effect from 1 June 2009. Annex XVII to that Regulation replaces Annex I to Directive 76/769/EEC. Following the provisions on transitional measures in Article 137 of REACH, it is appropriate to amend Annex XVII to Regulation (EC) No 1907/2006 in order to incorporate the restrictions provided for by Decisions 455/2009/EC (dichlormethane), 2009/424/EC (lamp oils and grill fighter fluids) and 2009/425/EC (organostannic compounds).

1. 12. 2009
15. 1. 2010

WP
WP

3. Draft Commission Regulation (EC) No …/.. of […] amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

Commission Regulation (EC) No 440/2008 contains the test methods for the purposes of the determination of the physico-chemical properties, toxicity and eco-toxicity of substances to be applied for the purposes of Regulation (EC) No 1907/2006.
It is necessary to update Regulation (EC) No 440/2008 to include changes to certain test methods and to include several new test methods adopted by the OECD. Stakeholders have been consulted on this proposal. Those amendments adapt the methods in question to scientific and technical progress.
Regulation (EC) No 440/2008 should therefore be amended accordingly.

27. 3. 2009
6. 5. 2009
11. 5. 2009
24. 8. 2009

WP
Coreper
Education, Youth and Culture Council
OJ EU L 220

4. Draft Commission Regulation (EU) No/.. of […] amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

With a view to facilitating worldwide trade while protecting human health and the environment, harmonised criteria for classification and labelling and rules for safety data sheets have been carefully developed over a period of more than 10 years within the United Nations (UN) structure, resulting in the Globally Harmonised System of Classification and Labelling of Chemicals (hereinafter referred to as ‘the GHS’). Annex II to Regulation (EC) No 1907/2006 should be amended to adapt it to the criteria for classification and other relevant provisions laid down in Regulation (EC) No 1272/2008.

28. 1. 2010

WP

TEXTILE

1. Draft Commission Directive ../…/EC of […] amending, for the purposes of its adaptation to technical progress, Annex II to Directive 96/73/EC of the European Parliament and of the Council on certain methods for quantitative analysis of binary textile fibre mixtures

Uniform methods for quantitative analysis of binary textile fibre mixtures are provided for in Directive 96/73/EC. On the basis of recent findings by the technical working group, [Directive 96/74/EC recast] was adapted to technical progress, by adding the fibre melamine to the list of fibres set out in Annexes I and V to that Directive. It is therefore, necessary to define uniform test methods for melamine. Directive 96/73/EC should therefore be amended accordingly.

16. 3. 2009
15. 9. 2009

WP
OJ EU L 242

2. Draft Commission Directive ../…/EC of […] amending, for the purposes of their adaptation to technical progress, Annexes I and V to Directive 2008/121/EC of the European Parliament and of the Council on textile names

Directive 2008/121/EC lays down rules governing the labelling or marking of products as regards their textile fibre content, in order to ensure that consumer interests are thereby protected. Textile products may be placed on the market within the Community only if Theky comply with the provisions of that Directive.
In view of recent findings by a technical working group, it is necessary, for the purposes of adapting Directive 2008/121/EC to technical progress, to add the fibre melamine to the list of fibres set out in the Annexes I and V to that Directive.
Directive 2008/121/EC should therefore be amended accordingly

16. 3. 2009
15. 9. 2009

WP
OJ EU L 242

ORGANOSTANNIC COMPOUNDS

Draft Commission Decision amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of organostannic compounds for the purpose of adapting its Annex I to technical progress

The use of organostannic compounds in consumer articles has been found to pose a risk to human health, particularly for children.
Although di-substituted and tri-substituted organostannic compounds have the same averse health effect, namely immunotoxicity via the thymus gland, and act in a cumulative way, the potency of the tri-substituted compounds (such as TBT and TPT) is greater than that of the di substituted compounds (DOT and DBT). Furthermore, tri-substituted organostannic compounds being emitted from articles for either consumer or professional use could have adverse effects on the environment – in particular on aquatic organisms. More severe restrictions should therefore be imposed on articles containing tri-substituted organostannic compounds.
Directive 76/769/EEC should therefore be amended accordingly.

30. 1. 2009
9. 2. 2009
11. 3. 2009
4. 6. 2009

WP
WP
Coreper
OJ EU L 138

LAMP OILS AND GRILL FIGHTER FLUIDS

Draft Commission Decision of […] amending, for the purpose of adaptation to technical progress, Annex I to Council Directive 76/769/EEC as regards restrictions on the marketing and use of lamp oils and grill lighter fluids

Since 1 July 2000 Directive 76/769/EEC restricts the sale to consumers of coloured and scented oils presenting an aspiration hazard for use in decorative lamps and labelled with the risk phrase R65. Although Council Directive 67/548/EEC on the classification, packaging and labelling of dangerous substances and Directive 1999/45/EC of the European Parliament and the Council on the classification, packaging and labelling of dangerous preparations provide that containers of grill lighter fluids and lamp oils, labelled with R65, have to be fitted with child resistant fastening, accidents still occur as containers are either not closed properly, or the substance has been transferred from large original containers to smaller containers without child-resistant fastenings.
According to data provided by national authorities, it has become apparent that the unscented and uncoloured lamp oils and grill lighter fluids, labelled R65, pose a risk to human health, and specifically to the health of young children, when ingested, causing breathing disturbances and disorders of the respiratory tract.
It is therefore necessary to strengthen current provisions on lamp oils used in decorative lamps and to ensure that substances and mixtures sold as grill lighter fluids intended for supply to the general public are appropriately labelled.
In order to minimise accidental ingestion by small children, packaging requirements should be introduced to make lamp oils and grill lighter fluids less likely to attract or arouse the curiosity of children and to avoid that these products are mistaken for drinks. The size of the container should also be limited to minimise accidents linked to the transfer from originál containers to smaller containers without child-resistant fastenings or appropriate labelling.
Regulation (EC) No 1907/2006 repeals and replaces Directive 76/769/EEC with effect from 1 June 2009. Annex XVII to that Regulation replaces Annex I to Directive 76/769/EEC. Any amendment to the restrictions adopted under Directive 76/769/EEC should therefore be incorporated in Annex XVII to Regulation (EC) No 1907/2006.
Directive 76/769/EEC should therefore be amended accordingly

16. 3. 2009
1. 4. 2009
4. 6. 2009

WP
Coreper
OJ EU L 138

METROLOGY - MAXIMUM PERMISSIBLE ERRORS

Proposal for a Commission Directive amending Directive 2004/22/EC of the European Parliament and of the Council on measuring instruments in respect of exploitation of the maximum permissible errors, as regards the instrument-specific annexes MI-001 to MI-005

Directive 2004/22/EC harmonises the requirements for the placing on the market and/or the putting into use of measuring instruments with a measuring function defined in the instrument-specific annexes MI-001 to MI-010. Measuring instruments must meet the essential requirements laid down in Annex I and in the relevant instrument-specific Annex.
The instrument-specific annexes of Directive 2004/22/EC contain requirements adapted to the different types of measuring instruments. These requirements include specific provisions on allowable errors in order to ensure the accuracy and performance of the measuring instrument and to guarantee that the error of measurement under rated operated conditions and in the absence of a disturbance does not exceed the defined Maximum Permissible Error (MPE) value.
Since new specifications have been developed as regards gas meters and volume conversion devices, the very specific requirement of point 2.1 of Annex MI-002 could cause obstacles to technical progress and innovation and create barriers to the free circulation of gas meters. It should therefore be replaced by a more general performance requirement.
Directive 2004/22/EC provides in point 7.3 of Annex I with regard to utility measuring instruments for a general protection against unduly biased errors outside the controlled range.
However, experience has shown that in order to guarantee that a measuring instrument does not exploit the Maximum Permissible Error (MPE) and systematically favour any of the parties involved in the transaction, it is necessary to require also protection against unduly biased errors inside the controlled range of these instruments. Directive 2004/22/EC should therefore be amended accordingly.

26. 1. 2009
11. 3. 2009
11. 11. 2009

WP
Coreper
OJ EU L 294

MOTOR VEHICLES

1. Draft Commission Regulation (EC) No …/.. of […] replacing Annex IX to Directive 2007/46/EC of the European Parliament and of the Council establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (“Framework Directive”)

1. The certificate of conformity, the template of which is set out in Annex IX to Directive 2007/46/EC, constitutes an official statement delivered to the buyer of the vehicle that a particular vehicle has been built in conformity with the requirements set out by Community type-approval legislation.
It is necessary to ensure that the information contained in the certificate of conformity is comprehensible for the consumers and economic operators involved. The template of the certificate of conformity should include all technical information which is of relevance for the authorities of the Member States to allow vehicles to be put into service.
Since the adoption of Commission Directive 2001/116/EC of 20 December 2001 adapting to technical progress Council Directive 70/156/EEC on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers, the template of the certificate of conformity has never been updated. It is therefore appropriate to update it in the light of the numerous substantial changes brought by Directive 2007/46/EC which will introduce EC whole vehicle type approval for commercial vehicles as from 29 April 2009.
It is appropriate in view of ensuring the proper operation of the Community type-approval process to update the Annexes to Directive 2007/46/EC in order to adapt them to the development of scientific and technical knowledge; Annex IX to Directive 2007/46/EC should be replaced accordingly.

13. 2. 2009
13. 5. 2009

WP
OJ EU L 118

2. Draft Commission Regulation (EC) No …/.. of […] laying down detailed rules for the implementation of Annex I to Regulation (EC) No. …/2008 of the European Parliament and of the Council on the type-approval of motor vehicles with regard to the protection of pedestrians and other vulnerable road users, amending Directive 2007/46/EC and repealing Directives 2003/102/EC and 2005/66/EC

Regulation (EC) No. …/2008 sets out the basic requirements for the protection of pedestrians and other vulnerable road users in the form of tests and limit values for the type-approval of vehicles and of frontal protection systems as separate technical units.
The tests set out in Regulation (EC) No. …/2008 are based on the requirements set out in Directive 2003/102/EC of the European Parliament and of the Council of 17 November 2003 relating to the protection of pedestrians and other vulnerable road users before and in the event of a collision with a motor vehicle and amending Council Directive 70/156/EEC and Directive 2005/66/EC of the European Parliament and of the Council of 26 October 2005 relating to the use of frontal protection systems on motor vehicles and amending Council Directive 70/156/EEC.
A study completed regarding the specifications of certain requirements set out in Directive 2003/102/EC indicated a need to provide amendments.

13. 2. 2009
25. 7. 2009

WP
OJ EU L 195

3. Draft Commission Directive ../…/EC amending, for the purposes of adapting it to technical progress, Directive 97/24/EC of the European Parliament and of the Council on certain components and characteristics of two or three-wheel motor vehicles

In order to take into account the specific behaviour of hybrid vehicles, the type-approval test procedure used for measuring gaseous pollutants from two and three-wheel vehicles should be adapted. For this purpose, it is appropriate to adopt a procedure similar to the one used in UNECE Regulation No 83 on Emission of pollutants according to engine fuel requirements.
To ensure that hybrid vehicles comply with the noise limits set out in Directive 97/24/EC in all their running modes it is also necessary to adapt the type-approval test procedure used for noise measurement set out in Directive 97/27/EC.
Directive 97/24/EC should therefore be amended accordingly.

24. 4. 2009
29. 4. 2009
18. 8. 2009

WP
Coreper
OJ EU L 213

4. Draft Commission Directive ../…/EC of […] amending, for the purposes of thein adaptation to technical progress, Council Directives 80/720/EEC, 86/298/EEC, 86/415/EEC and 87/402/EEC and Directives 2000/25/EC and 2003/37/EC of the European Parliament and of the Council relating to the type-approval of agricultural or forestry tractors.

As concerns Directive 80/720/EEC, it is appropriate to clarify which windows may be designated as emergency exits.
As concerns Directive 86/415/EEC, in order to improve safety of tractors it is suitable to specify safety requirements for the external controls of the power take-off.
As concerns Directive 86/415/EEC, the use of pictorials according to standards ISO 3767 1:1996 and ISO 3767-2:1996 as symbols for the controls should be allowed in order to adapt Community standards to the standards applied in the framework of controls of wheeled agricultural or forestry tractors worldwide.
As concerns Directive 2000/25/EC, certain additional indications need to be specified in order to be consistent with the introduction of new stage limits (IIIA, IIIB and IV), introduced by Directive 2005/13/EC.
As concerns Directive 2003/37/EC, a more precise wording for some points in the information documents should be included for reasons of clarity.
As concerns Directives 2003/37/EC, 86/298/EEC and 87/402/EEC, in view of the fact that OECD Decision C(2005) 1 of the OECD Council was most recently amended by Decision C(2008)128 of October 2008, it is appropriate to update the references to the OECD codes.
For reasons of legal certainty it is necessary to include the relevant texts of such OECD documents in the Directives.
Directives, 80/720/EEC, 86/298/EEC, 86/415/EEC, 87/402/EEC, 2000/25/EC and 2003/37/EC should be amended accordingly.

27. 10. 2009
4. 11. 2009

WP
Coreper

5. Draft Commission Regulation (EC) No …/.. of […] replacing Annexes V, X, XV and XVI to Directive 2007/46/EC of the European Parliament and of the Council establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (“Framework Directive”)

Directive 2007/46/EC establishes a harmonised framework containing the administrative provisions and general technical requirements for all new vehicles, systems, components and separate technical units. In particular it includes a description of the procedures to be followed with respect to type-approval including the practical measures to be taken in order to ensure that vehicles are produced in accordance with their type-approval documentation as well provisions concerning how tests must be conducted in order to be granted type-approval.
It is appropriate with a view to ensuring the proper operation of the type-approval system to update the Annexes to Directive 2007/46/EC in order to adapt them to the development of scientific and technical knowledge. Since the provisions of those annexes are sufficiently detailed and need not further transposition measures by Member States, it is therefore appropriate to replace them by means of a Regulation in accordance with Article 39(8) of Directive 2007/46/EC.
Annexes V, X, XV and XVI to Directive 2007/46/EC should be amended accordingly.

18. 11. 2009
25. 11. 2009

WP
Coreper

6. Draft Commission Directive ../…/EC of […] amending, for the purposes of adaptation to technical progress in the field of spray-suppression systems of certain categories of motor vehicles and their trailers, Council Directive 91/226/EEC, and Directive 2007/46/EC of the European Parliament and of the Council

Directive 91/226/EEC on the approximation of the laws of the Member States relating to the spray-suppression systems of certain categories of motor vehicles and their trailers is one of the separate directives in the context of the EC type-approval procedure established under Directive 2007/46/EC. The provisions of Directive 2007/46/EC relating to systems, components and separate technical units for vehicles therefore apply to Directive 91/226/EEC.
In view of the mandatory application of the EC type-approval procedure to all vehicle categories covered by Directive 2007/46/EC, it is necessary to provide harmonized requirements with regard to spray suppression for all vehicle categories covered by Directive 91/226/EEC. Furthermore, it is necessary to clarify that those requirements are not mandatory for off-road vehicles. Finally, in view of the experience gained, it is necessary to adapt Directive 91/226/EEC and, consequently, Annex IV to Directive 2007/46/EC to technical progress.
Directives 91/226/EEC and 2007/46/EC should therefore be amended accordingly

18. 11. 2009
25. 11. 2009

WP
Coreper

7. Draft Commission Directive ../…/EC of […] amending Directive 97/68/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery

Since Directive 97/68/EC provides for the type-approval of Stage III B engines (category L) as from 1 January 2010 it is necessary to provide for the possibility to grant type approval from that date.
For reasons of legal certainty this Directive should enter into force as a matter of urgency.

18. 11. 2009
25. 11. 2009

WP
Coreper

8. Draft Commission Regulation (EC) No…./.. of implementing Regulation (EC) No. 79/2009 of the European Parliament and of the Council on type-approval of hydrogen powered motor vehicles

Regulation (EC) No 79/2009 lays down fundamental provisions on requirements for the type approval of motor vehicles with regard to hydrogen propulsion, for the type-approval of hydrogen components and hydrogen systems and for the installation of such components and systems. From entry into force of the present Regulation manufacturers should be able to apply for the EC whole-vehicle type-approval of hydrogen-powered vehicles on a voluntary basis. However, some of the separate Directives in the context of the Community type-approval procedure under Directive 2007/46/EC or some of their requirements should not apply to hydrogen-powered vehicles, since the technical characteristics of hydrogen-powered vehicles differ significantly from conventional ones, for which those type-approval Directives were essentially designed. Pending the amendment of those Directives to include specific provisions and test procedures on hydrogen-powered vehicles, it is necessary to set out transitional provisions in order to exempt hydrogen-powered vehicles from those Directive or some of their requirements. Adopting harmonised rules on hydrogen receptacles, including receptacles designed to use liquid hydrogen, is necessary in order to ensure that hydrogen vehicles can be refuelled throughout the Community in a safe and reliable manner.

15. 1. 2010
27. 1. 2010

WP
Coreper