欧盟生物杀灭产品法规- BPR

欧盟生物杀菌产品法规528/2012 (BPR)涉及欧盟生物杀菌活性物质和产品的市场准入和使用. 的 regulation covers a very diverse group of product types including disinfectants, 防腐剂, 虫害控制, 防污防腐产品.

杀生的产品监管 于2013年9月生效,修订和取代BPD(指令98/8/EC),并为在欧盟内供应活性物质和将生物杀灭产品投放市场制定规则和程序.

该法规制定了欧盟级别活性物质的全面指导和批准标准,以及通过欧盟或国家授权框架进行生物杀灭产品评估的程序. It also provides the basis for the renewal of existing approved active substances. Whilst the approval of active substances is done at EU level, the authorisation of biocidal products is done at EU Member State level, 工会授权除外. Despite ongoing efforts at harmonisation 和 mutual recognition procedures, some Member States maintain different administrative or data requirements. 这些要求及其不断变化对希望将其生物杀灭产品投放到欧盟市场的公司来说是一个挑战.

AG8大厅登录可以帮助

  • AG8大厅登录的多学科科学家和注册专家团队拥有多年的经验,在欧盟和其他地区为生物杀灭活性物质和产品授权或注册获得生物杀灭产品的批准, 最近, 支持根据 GB生物杀菌剂条例
  • AG8大厅登录咨询可以代表欧盟第95条清单上的GB公司,也可以代表欧盟第95条清单上的欧盟公司
  • We work with both major chemical 公司 和 small suppliers, 针对每个公司的特定需求提供服务
  • We have wide-ranging expertise from working in industry, 监管当局, 和研究设施
  • AG8大厅登录相信积极主动的项目管理对于确保AG8大厅登录的客户的需求被及时发现和满足是至关重要的
  • AG8大厅登录拥有全面的泛欧洲基础设施,以应对欧盟各国不同要求带来的挑战,AG8大厅登录在法国设有办事处, 西班牙, 德国, 以及聚焦于英国发行, 本地注册支持
  • AG8大厅登录可以 provide support for non-EU 欧洲an countries including Switzerl和 和 Norway
  • AG8大厅登录有准备联盟授权提交文件的经验,并通过成员国评估和同行审查程序(包括生物杀灭产品委员会(BPC)会议)成功管理这些文件
  • AG8大厅登录可以帮助您理解新的生物杀灭剂产品系列指导,并可以建立您的产品系列,并确保您的产品系列战略有充分的理由
  • AG8大厅登录可以 support clients with endocrine disruptor data searches, 出版和监管数据的整理, 和 a full assessment according to the ECHA/EFSA guidance of June 2018

Need guidance building your biocide product family strategy?

为什么AG8大厅登录

AG8大厅登录 provides 公司 with high-quality regulatory 和 scientific consulting services. We aim to underst和 our clients' goals 和 objectives, 了解项目的科学和技术方面,并预见合规方面的挑战,以规划前进的战略路径. AG8大厅登录's team of experts is deadline-focused, responsive 和 committed to professionalism. We have the utmost respect for the confidentiality of our work, 较强的项目管理能力, 和 take great measure to cultivate long-term partnerships with clients.

AG8大厅登录的专业人员

AG8大厅登录 has a team of specialized biocides regulatory 咨询顾问 drawn from industry, 监管当局 和 contract research who manage all aspects of biocidal active substance approval, biocidal product authorisation/registration 和 战略规划. 由 艾米洞穴生物杀灭部主管 & Cosmetics, key professional working in the sector include 萨曼莎沃克, 菲利帕,马路, Severine Macke伊恩·尼科尔斯.

有用的信息

常见问题

ECHA将杀菌剂定义为:

——任何物质或混合物, 以提供给用户的形式, 组成的, 含有或产生一种或多种活性物质的, 意图破坏, 阻止, 呈现无害的, 阻止…的行动, 或以其他方式对…施加控制作用, any harmful organism by any means other than mere physical or mechanical action,

-任何物质或混合物, generated from substances or mixtures which do not themselves fall under the first indent, 以破坏为目的而使用, 阻止, 呈现无害的, 阻止…的行动, 或以其他方式对…施加控制作用, any harmful organism by any means other than mere physical or mechanical action.”

的 杀生的产品监管 (528/2012) classifies biocides into 22 product types (‘PTs’). 它们主要分为四大类:

Group 1 – Disinfectants (human hygiene; disinfectants 和 algaecides not intended for direct application to humans or animals; veterinary hygiene; food 和 feed areas; drinking water)

Group 2 – Preservatives (防腐剂 for products during storage; film 防腐剂; wood 防腐剂; fibre, 皮革, rubber 和 polymerised materials 防腐剂; construction material 防腐剂; 防腐剂 for liquid-cooling 和 processing systems; slimicides; working or cutting fluid 防腐剂)

Group 3 – Pest control (rodenticides; avicides; molluscicides, vermicides 和 products to control other vertebrates; piscicides; insecticides, acaricides 和 products to control other arthropods; repellents or attractants; control of other vertebrates)

Group 4 – 其他 biocidal products (antifouling products; embalming or taxidermist fluids)

No, 一个通知, 在您希望销售该产品的每个国家,通常都需要对该生物杀灭剂产品进行注册或授权.

产品注册/授权所需的数据要求取决于一些因素,例如建议的产品类型(PT), 特定产品使用, intended user (professional/non-professional) 和 country. 建议产品的配方类型和有效成分也会影响所需数据类型. T在这里 are many ways the data requirements can be addressed such as data references, 豁免和实验室世代. AG8大厅登录可以通过产品战略评估文档和/或数据差距分析,为您的建议产品提供特定的数据需求列表.

Article 3 of the 监管 (EU) No 528/2012 (EU BPR) defines a treated article as “any substance, 经过处理的混合物或物品, 或者故意了, 一种或多种生物杀灭产品."

W在这里 the primary function of a treated article is biocidal, the treated article will be treated as a biocidal product rather than a treated article.

Treated Articles must comply with the requirements in Article 58 of EU 杀虫剂 监管 528/2012.

潜在的,是的. A biocidal product family can be submitted if t在这里 are similar formula compositions, uses 和 levels of risk 和 efficacy a交叉 all the products. 有新的指导意见(CA-July19-Doc).4.2: 2019年7月达成的指导说明)关于产品族的说明,详细说明需要满足哪些条件. AG8大厅登录可以帮助评估您的产品是否适合某个产品系列,并确保您的产品系列战略有充分的理由.

在BPR, certain biocidal products can be authorised at Union level, allowing 公司 to place their biocidal products on the market throughout the entire 欧洲an Union, without the need to obtain a specific national authorisation in each country.

联盟授权将给予所有会员国与国家授权相同的权利和义务.

Union authorisation can be granted to biocidal products with similar conditions of use a交叉 the Union, 尽管有一些排除.

AG8大厅登录可以就哪些原料药可以包含在联盟授权申请中提出建议, as well as support clients in preparing Union authorisation submissions, managing them through the Member State evaluation 和 peer review processes.

计划在一个欧盟成员国销售生物杀灭剂产品的公司,必须在该国申请产品授权(国家授权). If a 公司 wishes to extend the national product authorisation to other markets within the EU, it can ask other Member States to recognise it through a process called mutual recognition. Applications for mutual recognition can either be made in sequence, or in parallel. AG体育平台 can advise on the most appropriate route for your 公司 to take, as well as support you through the mutual recognition process.

内分泌干扰物是在一定条件下会对人和动物的激素系统产生影响的化学物质. 必须对进入欧盟市场的生物杀灭产品中的每一种活性物质和共同制剂进行内分泌干扰物评估. 欧洲化学品署(ECHA)和欧洲食品安全局(EFSA)于2018年6月发布了关于如何对内分泌干扰物进行生物杀灭剂(和植物保护产品)评估的指南. Whilst the document aimed to 帮助 users comply with their obligations under the BPR, many questions remain as to what exactly is required of 公司, 由于欧洲主管当局对评估过程采取了不同的方法,这一过程远非简单. AG体育平台 supports 公司 in navigating the many nuances of biocides product legislation, 提供内分泌干扰物数据搜索, 根据ECHA/EFSA 2018年6月指南,整理来自已发表来源和监管研究的数据,并详细分析和证据权重报告.

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