委员会实施条例(EU) No 438/2014,批准环唑醇用于生物杀灭剂产品类型8中现有活性物质的申请

技术法规类型:欧盟Eurlex法规 来源:tbtmap

EURLEX ID:32014R0438

OJ编号:OJ L 128, 30.4.2014, p. 68-71

中文标题:委员会实施条例(EU) No 438/2014,批准环唑醇用于生物杀灭剂产品类型8中现有活性物质的申请

原文标题:Commission Implementing Regulation (EU) No 438/2014 of 29 April 2014 approving cyproconazole as an existing active substance for use in biocidal products for product-type 8 Text with EEA relevance

分类:03.50.20_植物健康

文件类型:二级立法 Regulation|条例

生效日期:2014-05-20

废止日期:2058-12-31

法规全文:查看欧盟官方文件

L_2014128EN.01006801.xml

30.4.2014

EN

Official Journal of the European Union

L 128/68


COMMISSION IMPLEMENTING REGULATION (EU) No 438/2014

of 29 April 2014

approving cyproconazole as an existing active substance for use in biocidal products for product-type 8

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the third subparagraph of Article 89(1) thereof,

Whereas:

(1)

Commission Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes cyproconazole.

(2)

Cyproconazole has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 8, wood preservatives, as defined in Annex V to that Directive, which corresponds to product-type 8 as defined in Annex V to Regulation (EU) No 528/2012.

(3)

Ireland was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 30 May 2012 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

(4)

The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated in an assessment report reviewed within the Standing Committee on Biocidal Products on 13 March 2014.

(5)

According to that assessment report, biocidal products used for product-type 8 and containing cyproconazole may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC provided that certain specifications and conditions relating to its use are satisfied.

(6)

It is therefore appropriate to approve cyproconazole for use in biocidal products for product-type 8 subject to compliance with such specifications and conditions.

(7)

Since the evaluation did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.

(8)

The report concludes that cyproconazole meets the criteria for being classified as toxic for reproduction category 1B in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (4), and for being very persistent (vP) and toxic (T) according to Annex XIII to Regulation (EC) No 1907/2006. Notwithstanding the fact that the existing harmonised classification of cyproconazole should be revised pursuant to Article 37 of Regulation (EC) No 1272/2008, those intrinsic properties should be taken into account for the purpose of determining the period of approval.

(9)

Since the conditions of the first subparagraph of Article 90(2) of Regulation (EU) No 528/2012 are not met, the current practice under Directive 98/8/EC should be followed. The period of approval should therefore be five years.

(10)

However, for the purpose of authorising products in accordance with Article 23 of Regulation (EU) No 528/2012, cyproconazole shall be considered as a candidate for substitution pursuant to Article 10(1)(a) and (d) of that Regulation.

(11)

A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements laid down.

(12)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

Cyproconazole shall be approved as an active substance for use in biocidal products for product-type 8, subject to the specifications and conditions set out in the Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 29 April 2014.

For the Commission

The President

José Manuel BARROSO


(1) OJ L 167, 27.6.2012, p. 1.

(2) Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).

(3) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).

(4) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).


ANNEX

Common name

IUPAC name

Identification numbers

Minimum degree of purity of the active substance (1)

Date of approval

Expiry date of approval

Product type

Specific conditions (2)

Cyproconazole

IUPAC Name:

(2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol

EC No: N/A

CAS No: 94361-06-5

Cyproconazole has two diastereomers.

Diastereomer A: enantiomeric pair, where the 2-hydroxy group and the 3-hydrogen are located on the same side (2S, 3S and 2R, 3R).

Diastereomer B: enantiomeric pair, where the 2-hydroxy group and 3-hydrogen are located on opposite sides (2R, 3S and 2S, 3R).

Technical cyproconazole is ca 1:1 mixture of the two diasteriomers, each of which is exactly a 1:1 mixture of the enantiomers.

940 g/kg

Cyproconazole has two diastereomers

(Diastereoisomer A: 430-500 g/kg,

Diastereoisomer B: 470-550 g/kg).

1 November 2015

31 October 2020

8

Cyproconazole is considered a candidate for substitution in accordance with Article 10(1)(a) and (d) of Regulation (EU) No 528/2012.

The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.

Authorisations are subject to the following conditions:

(1)

For industrial users, safe operational procedures and appropriate organizational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment.

(2)

Products shall not be authorised for industrial use by double vacuum impregnation, unless data is submitted to demonstrate that the product will not present unacceptable risks, if necessary by the application of appropriate mitigation measures.

(3)

Appropriate risk mitigation measures shall be taken to protect the soil and aquatic compartments. In particular:

a.

Labels and, where provided, safety data sheets of products authorised shall indicate that industrial application shall be conducted within a contained area or on impermeable hard standing with bunding, that freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal.

b.

Products shall not be authorised for industrial treatment of wood that will be exposed to weathering, or for treatment of wood that will be used for outdoor constructions, unless data is submitted to demonstrate that the product will not present unacceptable risks, if necessary by the application of appropriate mitigation measures.


(1) The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.

(2) For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm.


附件:

P020171219533753321999.pdf

托管标准,您可以接收以下服务:

1 标准定期系统查新,若有最新版本,会以站内短信或邮件的形式通知用户;

2 随时在标准托管页面中查看到该条标准的最新状态;

3 若用户有在学习和科研中的需要,可以在标准托管页面中试阅标准;

4 企业如果需要上新产品,我院及时提供标准查询、采购等方面的支持;

5 为企业在标准制修订、企业良好行为创建以及标准化试点过程中遇到的困难,可联系我院指定相关专家负责进行指导帮助、提供政策咨询;

6 为企业提供标准化政策的解读、标准化知识的推广培训、标准自我公开声明、标准文献的免费查询、企业标准化体系建设等方面的标准化服务;

进入企业标准托管

您可以通过编辑查新模板,批量查询指定标准集的最新情况。我们会通过查询,向您展示您所查询标准的:

1. 准确的标准号及标准名称(我们通过人工智能技术对您提交的标准号进行自动纠正)

2. 标准的最新状态(现行、废止或未发布)

3. 若标准已废止并被新标准替代,会反馈被替代的标准

4. 若您已托管此标准,便可以实时跟踪这个标准的最新状态

标准查新 模板下载

您可以在这里检索全球超过140万条标准,支持上百个国内国际标准组织的标准查询。您也可以在这里检索国内各类国家、部委和地方的法律法规。

更多标准子库在持续建设中。

标准检索

标准资讯点击排行榜 全部

资讯标题点击

[[ n.title ]] [[ n.read ]]

大连标准化公共服务平台

版权:大连标准化研究院有限公司

地址:大连市中山区高原街56号

电话:0411-82740851

大连标准