Activities of Corinne LEPAGE related to 2009/0076(COD)
Plenary speeches (2)
Placing on the market and use of biocidal products (A7-0239/2010, Christa Klaß) (vote)
Placing on the market and use of biocidal products (debate)
Shadow opinions (1)
OPINION Proposal for a regulation of the European Parliament and of the Council concerning the placing on the market and use of biocidal products
Amendments (74)
Amendment 72 #
Proposal for a regulation
Article 5
Article 5
1. Notwithstanding Article 4(1), the following active substances referred to in paragraph 2 shall not be included in Annex I only if at least one of the following conditions is met: (a) the exposure of humans to that active substance in a biocidal product, under normal conditions of use, is negligible, in particular where the product is used in closed systems or strictly controlled conditions; (b) it is shown that the active substance is necessary to control a serious danger to public health; (c) it is shown that not including the active substance in Annex I would cause disproportionate negative impacts when compared with: (a) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the crisk to human health or the environment arising from the use of the substance and that there are no suitable alternative substances or technologies. Point (c) shall not apply to active substances for product types 4 and 14 to 19. 2. The following active substances shall be included in Annex I where at least one of the conditions set out in paragraph 1 is met: teria to be classified as, carcinogens category 1A or 1B; (ab) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meets the criteria to be classified as, carcinomutagens category 1A or 1B; (b(c) active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, mutagetoxic for reproduction category 1A or 1B; (c(d) active substances which have been classified in accordance withidentified under Article 57(f) of Regulation (EC) No 1272907/20086 as, or having endocrine disrupting properties; (e) active substances which meet the criteria to befor classified as, toxic for reproduction category 1A or 1B; cation as substances persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) pursuant to Annex XIII to Regulation (EC) No 1907/2006; (df) active substances identified under Article 57(f) of Regulation (EC) No 1907/2006 as having endocrine disrupting propertieswhich are persistent organic pollutants as referred to in Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants .1 1 OJ L 158, 30.4.2004, p. 7.
Amendment 108 #
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
12a. A simplified assessment procedure should be set up for substances consisting of natural plant extracts whose toxicological profile does not pose a risk for human health.
Amendment 110 #
Council position
Article 1 – paragraph 1
Article 1 – paragraph 1
1. The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the making available on the market and the use of biocidal products, whilst ensuring a high level of protection of both human and animal health and the environment. The provisions of this Regulation are underpinned by the precautionary principle, the aim of which is to safeguard the health. The provisions of this Regulation are underpinned by the precautionary principle, in order to ensure that active substances or products placed on the market do not have harmful effects ofn humans, animals and the environment. non-target species and the environment. Special attention shall be paid to protecting children, pregnant women and the sick. Or. en (Reinstatement of amendment 341 from first reading.)
Amendment 110 #
Proposal for a regulation
Recital 13
Recital 13
(13) Active substances can, on basis of their intrinsic hazardous properties, be designated as candidates for substitution with other active substances, whenever such substances considered as efficient towards the targeted harmful organisms become available in sufficient variety to avoid the development of resistances amongst harmful organisms. In order to allow for a regular examination of substances identified as candidates for substitution, the inclusion period for these substances should not, even in the case of renewal, exceed tenfive years. Furthermore, the identification of substances which are considered as candidates for substitution should be considered as a first step of a comparative assessment.
Amendment 120 #
Proposal for a regulation
Recital 54
Recital 54
(54) It is necessary to provide for the effective communication of information on risks resulting from biocidal products and risk management measures as it forms an essential part of the system established by this Regulation. While facilitating access to information, competent authorities, the Agency and the Commission should respect the principle of confidentiality and avoid any disclosure of information which could be harmful for the commercial interests of the person concerned, except where this is necessary for the protection of human health and the environment.
Amendment 123 #
Council position
Article 3 – paragraph 1 – point (f) - subparagraph 2 – indent 2 a (new)
Article 3 – paragraph 1 – point (f) - subparagraph 2 – indent 2 a (new)
Amendment 126 #
Council position
Article 3 – paragraph 1 – point aa
Article 3 – paragraph 1 – point aa
(aa) ‘"nanomaterial’" means nanomaterial as defined in Commissionany intentionally produced material that has one or more dimensions of the order of 100 nm or less or is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale. Properties that are characteristic of the nanoscale include: (i) those related to the large specific surface area of the materials considered; and/or (ii) specific physico-chemical properties that are different from those of the non- nanoform of the same material. No later than six months after the adoption of Recommendation 20../…/EC of … … … concerning the definition of nanomaterials; , the Commission shall make a legislative proposal to include the definition in this Regulation. Or. en (Partial reinstatement of amendment 34 of first reading.)
Amendment 128 #
Council position
Article 4 – paragraph 1
Article 4 – paragraph 1
1. An active substance shall be approvedincluded in Annex -I for an initial period not exceeding 10 years if at least one biocidal product containing that active substance may be expected to meet the criteriafulfils the conditions laid down in point (b) of Article 18(1) taking into account the factors set out in Article 18(2) and (5). An active substance referred to in Article 5 may only be included in Annex I for an initial period of 5 years. (Note: This amendment applies throughout the text. If adopted, reference to "approval of an active substance" is to be replaced by reference to "inclusion of an active substance in Annex -I", reference to "approval" by "inclusion in Annex -I", reference to "approved" by "included in Annex -I" etc. throughout the text.) Or. en (Reinstatement of amendment 39 from first reading.)
Amendment 129 #
Council position
Article 5 – paragraph 1 – point d
Article 5 – paragraph 1 – point d
(d) active substances which, on the basis of the assessment of Union or internationally agreed test guidelines or other peer-reviewed scientific data and information, including a review of the scientific literature, reviewed by the Agency, are considered as having endocrine-disrupting properties that may cause adverse effect in humans, or which are identified in accordance with Articles 57(f) and 59(1) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties; . Or. en (Reinstatement of part of amendment 44 from first reading.)
Amendment 131 #
Council position
Article 5 – paragraph 2 – subparagraph 1 – point a
Article 5 – paragraph 2 – subparagraph 1 – point a
(a) the risk to humans or the environment from exposure to the active substance in a biocidal product, under realistic worst case conditions of use, is negligible, in particular wheremeaning that the product is used in closed systems or strictly controlled conditions; under other conditions excluding contact with humans; Or. en (Reinstatement of part of amendment 44 from first reading.)
Amendment 133 #
Council position
Article 5 – paragraph 2 – subparagraph 1 – point b
Article 5 – paragraph 2 – subparagraph 1 – point b
(b) it is shown by evidence that the active substance is essentialnecessary to prevent or to control a serious danger to public or animal health or to the environment; or (Reinstatement of part of amendment 44 from first reading. Linked to the amendment deleting, to food and feed safety, or to the public interest and that there are no effective alternative substances or technologies available. The use of any biocidal product containing active substances included in Annex I pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment is minimised. Member State authorising a biocidal product containing an active substance included in Annex I pursuant to this paragraph shall draw up a substitution plan concerning the control of the serious danger by other means including non- chemical methods, which are as effective as the biocidal product concerned and shall without delay transmit that plan to the Commission. The use of the biocidal product with the active substance concerned shall be restricted to those Member States where the serious danger has to be prevented or, if it occurs, controlled. Or. en Article 5(2)(c) and the last subparagraph - should be voted together.)
Amendment 135 #
Council position
Article 5 – paragraph 2 – subparagraph 1 – point c
Article 5 – paragraph 2 – subparagraph 1 – point c
Amendment 137 #
Council position
Article 5 – paragraph 2 – subparagraph 2
Article 5 – paragraph 2 – subparagraph 2
Amendment 139 #
Council position
Article 5 – paragraph 3 – subparagraph 1
Article 5 – paragraph 3 – subparagraph 1
Amendment 144 #
Proposal for a regulation
Article 3 – paragraph 1 – point u a (new)
Article 3 – paragraph 1 – point u a (new)
ua. ‘vulnerable groups’ means persons needing specific consideration when assessing the acute and chronic health effects of biocide products. These include inter alia pregnant and nursing women, infants and children, and the elderly ;
Amendment 151 #
Council position
Article 10 – paragraph 1 – point c a (new)
Article 10 – paragraph 1 – point c a (new)
Amendment 152 #
Council position
Article 10 – paragraph 1 – point d
Article 10 – paragraph 1 – point d
(d) there are reasons for concern linked to the nature of the critical effects, in particular developmental neurotoxic or immunotoxic effects which, in combination with the use patterns, amount to use that could still cause concern, such as high potential of risk to groundwater, even with very restrictive risk management measures;
Amendment 154 #
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. Where appropriate, mMaximum residue limits shall be established with respect to active substances included in Annex I in accordance with Regulation (EC) No 396/2005 of the European Parliament and of the Council [and Council Regulation (EEC) No 2377/90].
Amendment 156 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
Amendment 166 #
Council position
Article 17 – paragraph 6
Article 17 – paragraph 6
6. The authorisation holder shall notify each competent authority that has granted a national authorisation for a biocidal product family of each product within the biocidal product family at least 30 days before placing it on the market, except where a particular product is explicitly identified in the authorisation or the variation in composition concerns only pigments, perfumes and dyes within the permitted variations. The notification shall indicate the exact composition, trade name and suffix to the authorisation number. In the case of a Union authorisation, the authorisation holder shall notify the Agency and the Commission.
Amendment 167 #
Council position
Article 18 – paragraph 1 – point e a (new)
Article 18 – paragraph 1 – point e a (new)
Amendment 171 #
Council position
Article 18 – paragraph 5
Article 18 – paragraph 5
5. Notwithstanding paragraphs 1 and 4, a biocidal product may be authorised when the conditions laid down in paragraph 1(b)(iii) and (iv) are not fully met, or may be authorised for making available on the market for use by the general public when the criteria referred to in paragraph 4(c) are met, where notwhere it is shown by evidence that the biocidal product is necessary to prevent or control a serious danger to public or animal health or to the environment, to food and feed or to the public interest and that there are no effective alternative products or technologies available. The use of any biocidal product authorised pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment is minimised. A Member State authorising thea biocidal product would result in disproportionate negative impacts for society when compared to the risks to human or animal health or to the environment arising from tauthorised pursuant to this paragraph shall draw up a substitution plan concerning the control of the serious danger by other means including non- chemical methods, which are as effective as the biocidal product concerned and shall without delay transmit that plan to the Commission. The use of theany biocidal product under the conditions laid down in the authorisationauthorised pursuant to this paragraph shall be restricted to those Member States where the serious danger has to be prevented or, if it occurs, controlled.
Amendment 179 #
Proposal for a regulation
Article 5 – paragraph 2 – point d a (new)
Article 5 – paragraph 2 – point d a (new)
da) active substances which have developmental neurotoxic or immunotoxic effects.
Amendment 186 #
Proposal for a regulation
Article 54 – paragraph 4 a (new)
Article 54 – paragraph 4 a (new)
4a. No later than 2 years after the entry into force of this regulation, the Commission shall submit a report on the assessment of the risks to human health and the environment presented by nano- active and nano-biocidal substances and on the specific measures which should, if appropriate, be taken with regard to them.
Amendment 192 #
Council position
Article 24 – paragraph 1 – point b a (new)
Article 24 – paragraph 1 – point b a (new)
Amendment 194 #
Proposal for a regulation
Article 58 – paragraph 3 a (new)
Article 58 – paragraph 3 a (new)
3a. Biocidal products which include nanomaterials or which have been manufactured by means of the nanotechnology shall be clearly labelled as such.
Amendment 213 #
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
4. By way of derogation from Article 10(3), the inclusion of an active substance in Annex I that is considered as a candidate for substitution shall be renewed for a period not exceeding tenfive years.
Amendment 215 #
Council position
Article 36 – paragraph 1 – subparagraph 1 – introductory part
Article 36 – paragraph 1 – subparagraph 1 – introductory part
By way of derogation from Article 31(2), any of the Member States concerned may propose to refuse to grant an authorisation or to adjust the terms and conditions of the authorisation to be granted, provided that such a measure can be justified on grounds of: Or. en (Amendment to be coherent with amendment 342 from first reading.)
Amendment 216 #
Council position
Article 36 – paragraph 1 – subparagraph 1 – point c
Article 36 – paragraph 1 – subparagraph 1 – point c
(c) the protection of health and life of humans, animals or plants; particularly of vulnerable groups, or of animals or plants; Or. en (Partial reinstatement of amendment 343 from first reading)
Amendment 220 #
Council position
Article 36 – paragraph 1 – subparagraph 2
Article 36 – paragraph 1 – subparagraph 2
Any of the Member States concerned may, in particular, propose in accordance with the first subparagraph to, refuse to grant an authorisation or to adjust the terms and conditions of the authorisation to be granted for a biocidal product containing an active substance to which Article 5(2) or 10(1) applies. Or. en (Amendment to be coherent with amendment 342 from first reading.)
Amendment 223 #
Council position
Article 36 – paragraph 2 – subparagraph 2 – introductory part
Article 36 – paragraph 2 – subparagraph 2 – introductory part
If the Member State concerned is unable to reach agreement with the applicant or receives no reply from the applicant within 60 days of that communication it shall without delay inform othe Commission. In that case, the Commission: (Reinstatement of amendment 342 from first reading. Linked to the deletion of the rest of thisr Member States and the Commission of any decision taken in this respect and its justification. Or. en paragraph)
Amendment 224 #
Council position
Article 36 – paragraph 2 – subparagraph 2 – point a
Article 36 – paragraph 2 – subparagraph 2 – point a
Amendment 226 #
Council position
Article 36 – paragraph 2 – subparagraph 2 – point b
Article 36 – paragraph 2 – subparagraph 2 – point b
Amendment 228 #
Council position
Article 36 – paragraph 2 – subparagraph 3
Article 36 – paragraph 2 – subparagraph 3
Amendment 235 #
Council position
Article 41 – paragraph 1 – introductory part
Article 41 – paragraph 1 – introductory part
1. Applicants may apply for Union authorisation for biocidal products which have similar conditions of use across the Union and which fall within the following categories of biocidal products: (Partial reinstatement of amendment of am 359 from first reading , except any product that contains active substances that fall under Article 5 or 10: Or. en view to find a modified way with acompromise with Council.)
Amendment 239 #
Council position
Article 41 – paragraph 2 a (new)
Article 41 – paragraph 2 a (new)
Amendment 239 #
Proposal for a regulation
Article 16 – paragraph 1 – point b – subpoint iii
Article 16 – paragraph 1 – point b – subpoint iii
iii) it has no immediate or delayed unacceptable effects itself or as a result of its residues, directly or indirectly, on human or animal health, taking into account vulnerable groups;
Amendment 248 #
Proposal for a regulation
Article 16 – paragraph 5 – point b a (new)
Article 16 – paragraph 5 – point b a (new)
ba) developmental neurotoxic or immunotoxic effects.
Amendment 257 #
Council position
Article 57 – paragraph 2 a (new)
Article 57 – paragraph 2 a (new)
2 a. Member States, or where appropriate the Commission, may prohibit or restrict the making available on the market or the use of a treated article if an active substance contained in the biocidal product that it was treated with or incorporates is a candidate for substitution in accordance with Article 10(1).
Amendment 259 #
Council position
Article 57 – paragraph 3 – introductory part
Article 57 – paragraph 3 – introductory part
3. Where the release of the active substances contained in the biocidal products with which a treated article was treated or which it incorporates, is intended or expected under normal or reasonably foreseeable conditions of use, or where the active substance contained in the biocidal product with which a treated article was treated, or which it incorporates, is classified or meets the criteria for classification in accordance with Regulation (EC) No 1272/2008, or meets the criteria of Article 5(1)(d) or (e), the person responsible for the placing on the market of that treated article shall ensure that the label provides the following information: Or. en (Attempt to find a compromise between Council and Parliament.)
Amendment 260 #
Council position
Article 57 – paragraph 3 – point c a (new)
Article 57 – paragraph 3 – point c a (new)
Amendment 262 #
Council position
Article 57 – paragraph 4
Article 57 – paragraph 4
Amendment 269 #
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
Amendment 272 #
Council position
Article 64 – paragraph 3 – subparagraph 1 – introductory part
Article 64 – paragraph 3 – subparagraph 1 – introductory part
Every three years, from …47 , Member States shall submit to the Commission a report on the implementation of this Regulation in their respective territories. The report shall include: implementation reports shall be published annually on the relevant website of the Commission. The report shall include: Or. en (Reinstatement of amendment 199 from first reading.)
Amendment 273 #
Council position
Article 64 – paragraph 3 – subparagraph 1 – point b
Article 64 – paragraph 3 – subparagraph 1 – point b
(b) information on any poisonings and, where available, occupational diseases involving biocidal products. , especially regarding vulnerable groups, and the actions undertaken to lower the risk of future cases. Or. en (Reinstatement of amendment 200 from first reading.)
Amendment 275 #
Council position
Article 64 – paragraph 3 – subparagraph 1 – point b a (new)
Article 64 – paragraph 3 – subparagraph 1 – point b a (new)
Amendment 276 #
Council position
Article 64 – paragraph 4
Article 64 – paragraph 4
4. The Commission shall draw up a report on the implementation of this Regulation, in particular Article 57, by 1 January 2020 and every three years thereafter. The Commission shall submit the report to the European Parliament and to the Council. Or. en (Partial reinstatement of amendment 350 from first reading.)
Amendment 278 #
Council position
Article 64 – paragraph 4 a (new)
Article 64 – paragraph 4 a (new)
Amendment 279 #
Council position
Article 64 – paragraph 4 a (new)
Article 64 – paragraph 4 a (new)
Amendment 294 #
Council position
Article 66 – paragraph 2 a (new)
Article 66 – paragraph 2 a (new)
Amendment 295 #
Council position
Article 66 – paragraph 2 b (new)
Article 66 – paragraph 2 b (new)
Amendment 298 #
Council position
Article 68 – paragraph 2 – subparagraph 1 – point aa (new)
Article 68 – paragraph 2 – subparagraph 1 – point aa (new)
Amendment 312 #
Council position
Article 89 – paragraph 2 – subparagraph 1
Article 89 – paragraph 2 – subparagraph 1
Amendment 318 #
Council position
Annex II – point 5
Annex II – point 5
5. Tests submitted for the purpose of authorisation shall be conducted according to the methods described in Commission Regulation (EC) No 440/2008 of 30 May 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)66 . Methods listed in Annex I do not cover nanomaterials, except where specifically mentioned. However, if a method is inappropriate or not described, other methods shall be used which are, whenever possible, internationally recognised and must be justified in the application. scientifically satisfactory and the validity of which must be justified in the application. Or. en (Reinstatement of amendment 346 from first reading)
Amendment 337 #
Council position
Annex III – point 5
Annex III – point 5
5. Tests submitted for the purpose of authorisation shall be conducted according to the methods described in Regulation (EC) No 440/2008. Methods listed in Annex I do not cover nanomaterials, except where specifically mentioned. However, if a method is inappropriate or not described, other methods shall be used which are, whenever possible, internationally recognised and scientifically appropriate and must be justified in the application. scientifically satisfactory and the validity of which must be justified in the application Or. en (Reinstatement of amendment 293 from first reading.)
Amendment 343 #
Proposal for a regulation
Article 33 – paragraph 2 – subparagraph 1
Article 33 – paragraph 2 – subparagraph 1
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 propose that the European Parliament and the Council add other categories of biocidal products in paragraph 1 of this Article. The European Parliament and the Council shall act pursuant to Article 294 of the Treaty.
Amendment 344 #
Proposal for a regulation
Article 33 – paragraph 2 – subparagraph 2
Article 33 – paragraph 2 – subparagraph 2
Amendment 355 #
Proposal for a regulation
Article 38 – paragraph 1 – point a
Article 38 – paragraph 1 – point a
a) new knowledge or information on the effects of the active substance or biocidal product for humans or the environment, especially those regarding vulnerable groups;
Amendment 400 #
Proposal for a regulation
Article 47 – paragraph 2 – point a a (new)
Article 47 – paragraph 2 – point a a (new)
(aa) the indication 'treated with biocidal products';
Amendment 410 #
Proposal for a regulation
Article 47 – paragraph 2 – point d
Article 47 – paragraph 2 – point d
d) any hazard statement or precautionary statement set out in the authorisation for the biocidal product, especially regarding vulnerable groups.
Amendment 413 #
Proposal for a regulation
Article 47 – paragraph 2 – subparagraph 3
Article 47 – paragraph 2 – subparagraph 3
Amendment 419 #
Proposal for a regulation
Article 54 – paragraph 2 a (new)
Article 54 – paragraph 2 a (new)
2 a. Within 4 years after entry into force of this Regulation action plans shall be established and implemented at national level in order to support the sustainable use of biocidal products. Action plans shall be reviewed every three years.
Amendment 422 #
Proposal for a regulation
Article 54 – paragraph 3 – point b
Article 54 – paragraph 3 – point b
b) information on any poisonings involving biocidal products, especially regarding vulnerable groups.
Amendment 423 #
Proposal for a regulation
Article 54 – paragraph 4 a (new)
Article 54 – paragraph 4 a (new)
4a. Two years, at the latest, after the entry into force of this Regulation, the Commission shall submit a report on the assessment of the risks to human health and the environment presented by the use of nanomaterials in biocidal products and on specific measures which should be taken with regard to them.
Amendment 424 #
Proposal for a regulation
Article 54 – paragraph 4 b (new)
Article 54 – paragraph 4 b (new)
4b. Within five years after the entry into force of this Regulation, the Commission shall draw up a report on the impact of the spread of biocidal products in the environment. The Commission shall submit the report to the European Parliament and the Council.
Amendment 425 #
Proposal for a regulation
Article 54 – paragraph 4 c (new)
Article 54 – paragraph 4 c (new)
4c. Within two years after the entry into force of this Regulation, the Commission shall propose a revision of the Regulation so as to establish a simplified evaluation procedure for substances consisting of natural plant extracts whose toxicological profile does not give grounds for concern about human health.
Amendment 429 #
Proposal for a regulation
Article 55 – paragraph 2 – subparagraph 2
Article 55 – paragraph 2 – subparagraph 2
However, where urgent action is essential to protect human health, safety or the environment, the Agency or the competent authorities mayshall take the necessary measures to disclose the information referred to in this paragraph.
Amendment 435 #
Proposal for a regulation
Article 57 – paragraph 1
Article 57 – paragraph 1
1. Producers, importers and professional users of biocidal products shall keep records of the biocidal products they produce, place on the market or use for at least threen years. They shall make available the relevant information contained in these records to the competent authority on request.
Amendment 438 #
Proposal for a regulation
Article 58 – paragraph 2 – point b a (new)
Article 58 – paragraph 2 – point b a (new)
(ba) where appropriate, whether the product contains nanomaterials and any specific risks;
Amendment 441 #
Proposal for a regulation
Article 58 – paragraph 2 – point g
Article 58 – paragraph 2 – point g
g) if accompanied by a leaflet, the sentence "Read attached instructions before use" and where applicable warnings for vulnerable groups;
Amendment 443 #
Proposal for a regulation
Article 58 – paragraph 3
Article 58 – paragraph 3
3. Member States may require that bBiocidal products placed on the market of their territories arof the Member States shall be labelled in their national language or languages of the country where they are marketed.
Amendment 448 #
Proposal for a regulation
Article 66 – paragraph 2 – point i a (new)
Article 66 – paragraph 2 – point i a (new)
(ia) providing guidance and tools for the use phase, particularly: - measures for integrated pest management, for specified vermin, - monitoring biocidal product use - best practice of biocidal product use to limit use of such products to the minimum necessary dose, - pest management in sensitive areas like schools, workplaces, kindergartens, public spaces, lake, canal and river sides, geriatric care centres, - technical equipment for of biocidal product application and its inspection.
Amendment 451 #
Proposal for a regulation
Article 70 – paragraph 2 – point b a (new)
Article 70 – paragraph 2 – point b a (new)
(ba) the fee structure shall take into account the fact that the product submitted for authorisation complies with the criteria for a low-risk product;
Amendment 574 #
Proposal for a regulation
Annex VI – evaluation – point 20 – indent 9 a (new)
Annex VI – evaluation – point 20 – indent 9 a (new)
– – immunotoxicity