BETA

Activities of Christa KLASS related to 2009/0076(COD)

Plenary speeches (3)

2016/11/22
Dossiers: 2009/0076(COD)

2016/11/22
Dossiers: 2009/0076(COD)

2016/11/22
Dossiers: 2009/0076(COD)

Reports (2)

2016/11/22
Committee: ENVI
Dossiers: 2009/0076(COD)
Documents: PDF(639 KB) DOC(971 KB)

2016/11/22
Committee: ENVI
Dossiers: 2009/0076(COD)
Documents: PDF(1 MB) DOC(2 MB)

Amendments (48)

Council position
Recital 21

(21) Processing aids are covered by existing Union legislation, in particular Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition and Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. Wine processing products are covered by Commission Regulation (EC) No 606/2009 of 10 July 2009 laying down certain detailed rules for implementing Council Regulation (EC) No 479/2008 as regards the categories of grapevine products, oenological practices and the applicable restrictions1. Therefore, it is appropriate to exclude them from the scope of this Regulation. ___________ 1 OJ. L 193, 24.7.2009, p. 1.

2011/09/13
Committee: ENVI

Council position
Article 2 – paragraph 5 – point b

(b) processing aids and wine processing products that are used as biocidal products.

2011/09/13
Committee: ENVI

Proposal for a regulation
Recital 60

(60) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission15 . __________________________________ 15deleted OJ L 184, 17.7.1999, p. 23.

2010/03/18
Committee: ENVI

Proposal for a regulation
Recital 61

(61) In particular, the Commission should be empowered to adopt measures to decide on the application to include the active substance in Annex I or to renew or review the inclusion, to specify the procedures related to the renewal and review of an inclusion of an active substance in Annex I, to extend the provisions on Community authorisations to other categories of biocidal products, to specify the criteria and procedures related to a cancellation of an authorisation or amendments of the terms and conditions of an authorisation, including a dispute settlement mechanism, to specify the overall applicable maximum quantities of active substances or biocidal products that may be released during experiments and the minimum data to be submitted, to establish a harmonised structure of fees and other rules concerning the payment of fees and charges to the competent authorities and the Agency, to adapt the Annexes to scientific and technical progress, to carry out the work programme and to specify the related rights and obligations of the competent authorities and the participants in the programme and to extend the duration of the work programme for a determined period. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing this Regulation with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.deleted

2010/03/18
Committee: ENVI

Proposal for a regulation
Recital 62

(62) When, on imperative grounds of urgency, the normal time limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of decisions to amend the inclusion of an active substance in Annex I or to remove it from that Annex on basis of Article 13.deleted

2010/03/18
Committee: ENVI

Proposal for a regulation
Recital 62 a (new)

62a. According to Article 291 TFEU, rules and general principles concerning mechanisms for control, by Member States, of the Commission's exercise of implementing powers are to be laid down in advance by a regulation adopted in accordance with the ordinary legislative procedure. Pending the adoption of that new regulation, and given the necessity to adopt as soon as possible this Regulation, control by Member States should be exercised in accordance with the provisions of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission, insofar as those provisions remain compatible with the amended Treaties. References to those provisions should nevertheless be replaced with references to the rules and principles set out in the new regulation as soon as that regulation enters into force.

2010/03/18
Committee: ENVI

Proposal for a regulation
Article 4 – paragraph 2 a (new)

2a. Active substances as such or in biocidal products may only be placed on the market in the Union for use in biocidal products if they have been included in Annex I in accordance with the provisions of this Regulation.

2010/03/18
Committee: ENVI

Proposal for a regulation
Article 4 - paragraph 2 b (new)

2b. Unless otherwise provided in this Regulation, all manufacturers of an active substance shall submit to the Agency an application for inclusion in Annex I.

2010/03/18
Committee: ENVI

Holger KRAHMER, Christa KLASS

Council position
Article 18 – paragraph 2 – point b a (new)

(b a) The evaluation of the compliance of the biocidal product with the criteria set out in points (b) and (c) of paragraph 1 shall not take into account a substance contained in the biocidal product if it is present in a preparation at a concentration lower than any of the concentrations mentioned in points (a) to (f) of Article 14(2) of Regulation (EC) No 1907/2006;

2011/09/13
Committee: ENVI

Holger KRAHMER, Christa KLASS

Council position
Article 21 – paragraph 2 – point e

(e) qualitative and quantitative composition in terms of the active substances and non- active substances, knowledge of which is essential for proper use of biocidal products; and in the case of a biocidal product family, the quantitative composition shall indicate a minimum and maximum percentage for each active and non-active substance, where the minimum percentage indicated for certain substances may be 0 %taking account of the concentration limits in Article 18(2b) and in so far as this information is required for proper use of the biocidal product;

2011/09/13
Committee: ENVI

Council position
Article 21 – paragraph 2 – point g

~~(g) manufacturers of the active substances (names and addresses including location of manufacturing sites);~~deleted

2011/09/13
Committee: ENVI

Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1

4. ~~The Commission shall adopt the measures designed to set the criteria~~In order to defin~~ing~~e what constitutes adequate justification to adapt the data required under paragraph 1 on the ground referred to in paragraph 2(a), the Commission shall adapt the criteria by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c.

2010/03/18
Committee: ENVI

Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1

~~Those measures designed to amend non- essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).~~deleted

2010/03/18
Committee: ENVI

Proposal for a regulation
Article 8 – paragraph 5

5. ~~On receipt of the opinion of the Agency, the Commission shall adopt a decision on the applicat~~In order to keep the list of authorised active substances updated, on receipt of the opinion of the Agency, the Commission shall adopt, by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c, a decision to include the active substance in Annex I. ~~That deci~~If the Commission, de~~signed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4)~~cides to include the substance in Annex I, the name of the applicants shall be given.

2010/03/18
Committee: ENVI

Esther DE LANGE, Christa KLASS

Council position
Article 36 – paragraph 1 – subparagraph 1 – point e a (new)

(e a) implementation of other Union legislation, and in particular Directive 98/83/EC.

2011/09/13
Committee: ENVI

Proposal for a regulation
Article 12 – paragraph 5

5. AIn order to keep the list of authorised active substances updated, at the end of the period referred to in paragraph 3 or on receipt of the opinion of the Agency, the Commission shall adopt, by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c, a decision concerning a renewal of the inclusion of the active substance in Annex I. ~~That dec~~If the Commission, de~~signed to amend non- essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4)~~cides to renew the inclusion of an active substance in Annex I, the name of the applicants shall be mentioned.

2010/03/18
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 1

1. TIn order to keep the list of authorised active substances updated, the Commission may review the inclusion of an active substance in Annex I at any time where there are serious indications that the requirements referred to in Article 4 are no longer complied with. Where those indications are confirmed, the Commission shall adopt, by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c, a decision amending the inclusion of an active substance in Annex I or removing it from that Annex.

2010/03/18
Committee: ENVI

Proposal for a regulation
Article 13 – paragraph 1 – subparagraph 2

That decision, designed to amend non- essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 72(5).deleted

2010/03/18
Committee: ENVI

Proposal for a regulation
Article 14 – title

~~Implementing measures~~Detailed procedures for renewal and review

2010/03/18
Committee: ENVI

Proposal for a regulation
Article 14 – paragraph 1

TIn order to ensure the smooth functioning of the renewal and review procedures, the Commission may adopt further detailed measures ~~for the implementation of Articles 10 to 13 of this Regulation specifying the procedures related to the renewal and review of an inclus~~by means of delegated acts in accordance with Article 71 a and subject to the conditions of ~~an active substance in Annex I~~Articles 71 b and 71 c.

2010/03/18
Committee: ENVI

Proposal for a regulation
Article 14 – paragraph 2

Those measures, designed to amend non- essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).deleted

2010/03/18
Committee: ENVI

Proposal for a regulation
Article 15 – paragraph 5 a (new)

5a. Infestation with harmful organisms is to be avoided by suitable measures of deterrence to banish or repel these organisms. In addition, other precautionary steps have to be taken, e.g. proper warehousing of goods, compliance with hygiene standards and immediate disposal of waste. Only after these measures show no effect, further steps should be taken. Biocidal products that pose low risks for humans, animals and the environment should always be used prior to others. Biocidal products that are intended to harm, kill or destroy animals that are capable of experiencing pain and distress should only be applied as a last resort.

2010/04/08
Committee: ENVI

Council position
Article 41 – paragraph 1 – point a

(a) biocidal products of product-types 61, 2, 3, 74, 95, ~~10, 12, 13 and 22~~6, 8, 13, 18, 19; and

2011/09/14
Committee: ENVI

Proposal for a regulation
Article 19 – paragraph 3 – subparagraph 1

3. ~~The Commission shall adopt the measures designed to set the criteria~~In order to defin~~ing~~e what constitutes adequate justification to adapt the data required under Article 18 on the ground referred to in paragraph 1(a), the Commission shall adapt the criteria by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c.

2010/04/08
Committee: ENVI

Proposal for a regulation
Article 19 – paragraph 3 – subparagraph 2

~~Those measures designed to amend non- essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).~~deleted

2010/04/08
Committee: ENVI

Council position
Article 65 – paragraph 3 – point c

~~(c) the name and address of the active substance manufacturer;~~deleted

2011/09/14
Committee: ENVI

Proposal for a regulation
Article 21 – paragraph 5 – subparagraph 2

~~The Commission shall adopt implementing rules~~In order to specify~~ing~~ the procedures related to comparative assessments involving questions of Community interest~~. Those rules, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in~~, the Commission shall adapt the criteria by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 7~~2(4)~~1 b and 71 c.

2010/04/08
Committee: ENVI

Holger KRAHMER, Christa KLASS

Council position
Annex III - Title 1 - point 2.3 - Column 1

2.3. ~~Complete~~Detailed quantitative ~~(g/kg, g/l or % w/w (v/v))~~and qualitative information on the composition of the biocidal product, i.e. declaration of all active substances and co-formulants (substance or mixture according to Article 3 of Regulation (EC) No 1907/2006), which are intentionally added to the biocidal product (formulation) as well as detailed quantitative and qualitative informatione.g. active substance(s), impurities, adjutants, inert components, taking account onf the composition of the active substance(s) contained. For co- formulants, a safety data sheet in compliance with Article 31 of Regulation (EC) No 1907/2006 has to be provided. In addition, all relevant information on individual ingredients, their function and, in case of a reaction mixture, the final composition of the biocidal product shall be given. ncentrations referred to in Article 18(2)(ba) Or. en (Reinstatement of amendment 296 from first reading.)

2011/09/14
Committee: ENVI

Proposal for a regulation
Article 33 – paragraph 2

2. Following the report of the Commission on the implementation of this Regulation referred to in Article 54(4) and in light of the experience gained with the Community authorisations, the Commission may add other categories of biocidal products in paragraph 1 of this Article. Those measures, designed to amend non- essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).deleted

2010/03/19
Committee: ENVI

Council position
Annex III – Title 2 – 8.7. – Column 1

8.7. Available toxicological data relating to: -– co-formulants (i.e. substance(s) of concern), or -– a mixture that a substance(s) of concern is a component of . If noinsufficient data isare available~~, then the appropria~~ for a coformulant(s) and cannot be inferred through read-across or other accepted non-testing approaches, targeted acute test(s) described in Annex II, shall be carried out for the ~~co-formulants (i.e.~~ substance(s) of concern) or a mixture that a substance(s) of concern is a component of.

2011/09/14
Committee: ENVI

Proposal for a regulation
Article 42 – title

~~Implementing measure~~Detailed procedures on cancellation and amendments

2010/03/19
Committee: ENVI

Proposal for a regulation
Article 42 – paragraph 1

TIn order to ensure the smooth functioning of the cancellation and amendment procedures, the Commission shall adopt ~~implementing~~further detailed measures specifying the criteria and procedures related to a cancellation of an authorisation or amendments of the terms and conditions of an authorisation under Articles 39 to 41, including a dispute settlement mechanism. by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c.

2010/03/19
Committee: ENVI

Proposal for a regulation
Article 42 – paragraph 2

Those measures, designed to amend non- essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).deleted

2010/03/19
Committee: ENVI

Proposal for a regulation
Article 46 – paragraph 4 – subparagraph 1

4. ~~The Commission shall adopt~~In order to encourage the research and development in active substances and biocidal products, the Commission shall adopt, by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c, measures to specify the overall applicable maximum quantities of active substances or biocidal products that may be released during experiments and the minimum data to be submitted in accordance with paragraph 2.

2010/03/19
Committee: ENVI

Proposal for a regulation
Article 46 – paragraph 4 – subparagraph 2

~~Those measures designed to amend non- essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).~~deleted

2010/03/19
Committee: ENVI

Proposal for a regulation
Article 50 – paragraph 2

2. Revocation of a letter of access prior to its expiry date shall ~~not affect the validity of~~invalidate the authorisation ~~issued~~drawn up on the basis of the letter of access in question with immediate effect, unless another letter of access for an equivalent active substance is submitted by the holder of the authorisation within four months.

2010/03/19
Committee: ENVI

Proposal for a regulation
Article 60 – paragraph 5

5. The Commission may adopt detailed rules on the types of information to be entered in the Community Register for Biocidal Products and the procedures related to it, in accordance with the procedure referred to in Article 72(2)In order to ensure the proper functioning of the Community Register for Biocidal Products, The Commission may adopt, by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c, detailed rules on the types of information to be entered in the Register and the procedures related to it.

2010/03/19
Committee: ENVI

Proposal for a regulation
Article 71 a (new)

Article 71a Exercise of the delegation 1. The powers to adopt delegated acts referred to in Articles 6(4), 8(5), 12(5), 13(1), 14, 19(3), 21(5), 42, 46(4), 60(5), 70(1), 73 and 77(1) shall be conferred on the Commission for a period of 5 years following the entry into force of this Directive. The Commission shall make a report in respect of the delegated powers at the latest 6 months before the end of the 5 year period. The delegation of powers shall be automatically extended for periods of an identical duration, unless the European Parliament and the Council revokes it in accordance with Article 71b. 2. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council 3. The powers to adopt delegated acts are conferred on the Commission subject to the conditions laid down in Articles 71b and 71c.

2010/03/19
Committee: ENVI

Proposal for a regulation
Article 71 b (new)

Article 71b Revocation of the delegation 1. The delegation of powers referred to in Articles 6(4), 8(5), 12(5), 13(1), 14, 19(3), 21(5), 42, 46(4), 60(5), 70(1), 73 and 77(1) may be revoked at any time by the European Parliament or by the Council. 2.The institution which has commenced an internal procedure for deciding whether to revoke the delegation of powers shall endeavour to inform the other institution and the Commission within a reasonable time before the final decision is taken, indicating the delegated powers which could be subject to revocation and possible reasons for a revocation. 3. The decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect immediately or at a later date specified therein. It shall not affect the validity of the delegated acts already in force. It shall be published in the Official Journal of the European Union.

2010/03/19
Committee: ENVI

Proposal for a regulation
Article 71 c (new)

Article 71c Objections to delegated acts 1. The European Parliament or the Council may object to a delegated act within a period of three months from the date of notification. At the initiative of the European Parliament or the Council this period shall be extended by one month. 2. If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act it shall be published in the Official Journal of the European Union and shall enter into force at the date stated therein. 3. If the European Parliament or the Council objects to a delegated act, it shall not enter into force. The institution which objects shall state the reasons for objecting to the delegated act.

2010/03/19
Committee: ENVI

Proposal for a regulation
Article 72 – paragraph 5

~~5. Where reference is made to this paragraph, Article 5a (1), (2), (4) and (6), and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.~~deleted

2010/03/19
Committee: ENVI

Proposal for a regulation
Article 73 – paragraph 1

~~The Commission may adapt~~In order to take account of technical progress, the Commission may adapt, by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c, the Annexes to scientific and technical progress.

2010/03/19
Committee: ENVI

Proposal for a regulation
Article 73 – paragraph 1

The Commission ~~may~~shall adapt the Annexes to scientific and technical progress.

2010/03/19
Committee: ENVI

Proposal for a regulation
Article 73 – paragraph 2

~~Those measures, designed to amend non- essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).~~deleted

2010/03/19
Committee: ENVI

Proposal for a regulation
Article 77 – paragraph 1 – subparagraph 1

1. The Commission shall carry on with the work programme for the systematic examination of all existing active substances commenced in accordance with Article 16(2) of Directive 98/8/EC and achieve it by 14 May 2014. The Commission may adopt implementing rules to carry out the work programme and to specify the related rights and obligations of the competent authorities and the participants in the programme. Those measures, designed to amend non- essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4)In order to ensure the smooth transition, the Commission may adopt, by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c, implementing rules to carry out the work programme and to specify the related rights and obligations of the competent authorities and the participants in the programme; and, depending upon the progress of the work programme, a decision to extend the duration of the work programme for a determined period.

2010/03/19
Committee: ENVI

Proposal for a regulation
Article 77 – paragraph 1 – subparagraph 2

Depending upon the progress of the work programme, the Commission may extend the duration of the work programme for a determined period. That measure, designed to amend non-essential elements of this Regulation by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).deleted

2010/03/19
Committee: ENVI

Proposal for a regulation
Article 77 – paragraph 1 – subparagraph 3

~~During~~In order to progress with the work programme, the Commission shall decide ~~pursuant to the procedure laid down in~~, by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 7~~2(4)~~1 b and 71 c, that an active substance shall be included in Annex I of this Regulation and under which conditions, or, in cases where the requirements of Article 4 are not satisfied or where the requisite information and data have not been submitted within the prescribed period, that such active substance shall not be included in Annex I of this Regulation. The decision shall specify the date on which the inclusion in Annex I becomes effective.

2010/03/19
Committee: ENVI

Proposal for a regulation
Annex V – Product-type 9

Products used for the preservation of fibrous or polymerised materials, such as leather, rubber or paper or textile products and rubber by the control of microbiological deterioration. These include products which inhibit surface build-ups of microorganisms (e.g. pathogenic or odour-generating germs) and thus curb or prevent the creation of odours and/or have other uses.

2010/04/08
Committee: ENVI