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The 博e乐官方 博e乐官方 博e乐官方 (博e乐官方) refers to 博e乐官方 (博e乐官方) 528/2012 concerning the placing on the market and use of biocidal products. The 博e乐官方 came into force on September 1, 2013, and covers the responsibilities of biocidal product manufacturers and importers. Article producers who use biocidal products to treat their products are also regulated.

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1. Active substance: A substance or a micro-organism that has an effect or action on or against harmful organisms.

2. 博e乐官方 product: Any substance or mixture, consisting of, containing, or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.

3. Treated article: Articles that have been treated with, or intentionally incorporated, one or more biocidal product.

Under the 博e乐官方-博e乐官方 博e乐官方, there are four main groups and 22 product types for the classification of 博e乐官方 products, which are listed in the table below:

*Note: A treated article that has a primary biocidal function should be considered a biocidal product.

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It is required that only biocidal products that contain an approved active substance can be sold and used on the 博e乐官方 market. The approved active substance list can be found in the below link:

• Approved active substance list – ECHA

There are two special conditions that allow companies to put biocidal products containing active substances that are not listed in the Approved active substance list on the 博e乐官方 market:

• The transitional provisions laid down in Article 89 of 博e乐官方 (博e乐官方) No 528/2012 allow biocidal products containing an active substance included in the Review Programme (for a given product type) to be made available on the market and used, subject to national rules, until three years after the date of their approval (shorter timeframes apply in case of non-approval).
• 博e乐官方 products containing new active substances that are still under assessment may also be allowed to be put on the 博e乐官方 market where provisional authorization is granted.

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A biocidal product is not able to be placed on the 博e乐官方 market if the active substance supplier or product supplier is not listed in the active substances suppliers list, which is also called Article 95 list.

The purpose of Article 95 is to make sure that the total costs of acquiring the data on active substances are shared fairly. Suppliers of active substances or biocidal products will only be included in Article 95 after they have applied and submitted the required information for inclusion in the active substances supplier list.

ECHA will update Article 95 periodically. Non-博e乐官方 companies can appoint an 博e乐官方-based representative to apply for inclusion in Article 95. The list can be found in the below link:

• Article 95 List – ECHA

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The 博e乐官方 requires that articles only be treated with biocidal products containing active substances that have been approved in the 博e乐官方. This also applies to imported articles. Companies are also required to provide consumers with information about the biocidal treatment of the article they are selling in the 博e乐官方 market. If a consumer requests information about a treated article, the supplier must provide it free of charge within 45 days.

The 博e乐官方 requires manufacturers and importers of treated articles to label the treated articles when:

• a claim that the treated article has biocidal properties is made.

• it is required in the conditions of the approval of the active substance contained in the biocidal product used to treat the article.

The labeling of treated articles must be done according to both the Classification, Labeling and Packaging of Substances and Mixtures (CLP) regulation and the additional requirements in the 博e乐官方-博e乐官方.

Obligations

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• Check whether their products are covered by 博e乐官方 regulation.
• Check whether their active substances have been approved by ECHA in the 博e乐官方.
• Apply for inclusion in Article 95 List.
• Apply for approval of new active substance (if necessary).

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• Check whether the active substances have been approved.
• Check whether the supplier of the active substance is listed in Article 95.
• Apply for product authorization.

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• Check whether the article needs to be treated with a biocidal product; if yes, only use approved active substances to treat articles.
• Check if any claim is made regarding the biocidal properties or functions of the treated article; if yes, label the treated article accordingly.
• Provide information on the biocidal treatment of the article to the downstream users.

Only Representative

If a non-博e乐官方 manufacturer or supplier of the active substance or biocidal product can not get the support of 博e乐官方-博e乐官方 compliance from their 博e乐官方 importers, they can appoint an Only Representative (OR) to submit the registration or materials on behalf of them to fulfill the obligations under 博e乐官方-博e乐官方.

Our Services:

• Only representative under 博e乐官方-博e乐官方;
• Active substance authorization approval;
• Biocide product authorization approval;
• Apply for inclusion of suppliers into Article 95.