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1.
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Notifying
Member: EUROPEAN UNION
If applicable, name of local government involved (Article 3.2 and
7.2):
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2.
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Agency
responsible:
European
Commission
Name and address (including telephone and fax numbers, email and
website addresses, if available) of agency or authority designated to handle
comments regarding the notification shall be indicated if different from
above:
European Commission,
EU-TBT Enquiry Point,
Fax: +(32) 2 299 80 43,
E-mail: grow-eu-tbt@ec.europa.eu
Website:
http://ec.europa.eu/growth/tools-databases/tbt/
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3.
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Notified
under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ],
other:
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4.
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Products
covered (HS or CCCN where applicable, otherwise national tariff heading. ICS
numbers may be provided in addition, where applicable): Biocidal products
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5.
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Title,
number of pages and language(s) of the notified document: Draft Commission Implementing Decision not approving ethylene
oxide as an existing active substance for use in biocidal products of
product-type 2 in accordance with Regulation (EU) No 528/2012 of the European
Parliament and of the Council; (5 page(s), in English)
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6.
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Description
of content: This draft Commission
Implementing Decision does not approve ethylene oxide as an existing active
substance for use in biocidal products of product-type 2.
The
Commission services concluded that none of the uses of ethylene oxide that
the applicant included in the application for approval under the Regulation
(EU) No 528/2012 (the BPR), or mentioned as further intended uses in their
communication with the Commission, are covered by the scope of the BPR, but
instead fall within the scope of the Union legislation on medicinal products
or on medical devices.
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7.
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Objective
and rationale, including the nature of urgent problems where applicable: Protection of public health and of the environment. Harmonisation
of the EU market on biocidal products.; Protection of human health or safety;
Protection of the environment; Harmonization
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8.
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Relevant
documents:
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
(OJ L 167, 27.6.2012, p. 1.). Available in all EU languages.
EUR-Lex - 32012R0528 - EN - EUR-Lex (europa.eu)
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9.
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Proposed
date of adoption: February 2025
Proposed date of entry into force: 20 days from publication in the Official Journal of the EU
(Application 12 months after adoption)
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10.
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Final
date for comments: 60 days from
date of notification
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11.
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Texts available from: National enquiry
point [ ] or address, telephone and fax numbers and email and website
addresses, if available, of other body:
European Commission,
EU-TBT Enquiry Point,
Fax: + (32) 2 299 80 43,
E-mail: grow-eu-tbt@ec.europa.eu
https://members.wto.org/crnattachments/2024/TBT/EEC/24_07908_00_e.pdf
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