Notification Detail

Regulations amending the Swedish Chemicals Agency’s regulations (KIFS 2017:5) on chemical products and biotechnological organisms

Notification Number: 2017/227/S (Sweden)
Date received: 07/06/2017
End of Standstill: 08/09/2017

Issue of comments by: Austria,Commission
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Message 002

Communication from the Commission - TRIS/(2017) 01398
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2017/0227/S

No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.

(MSG: 201701398.EN)

1. Structured Information Line
MSG 002 IND 2017 0227 S EN 07-06-2017 S NOTIF


2. Member State
S


3. Department Responsible
Kommerskollegium
Box 6803, 113 86 Stockholm
Sverige
Tel: 08-690 48 00, Fax: 08-30 67 59
epost: 9834@kommers.se


3. Originating Department
Kemikalieinspektionen
Box 2; SE 172 13 Sundbyberg
Tel: 08-51941399
Christopher.kellner@kemi.se


4. Notification Number
2017/0227/S - C00C


5. Title
Regulations amending the Swedish Chemicals Agency’s regulations (KIFS 2017:5) on chemical products and biotechnological organisms


6. Products Concerned
Chemical products


7. Notification Under Another Act
- The basic regulations of the notified draft have not yet been adopted, but the plan is for them to be adopted on 14 June 2017. Once the concerned notification procedure has been completed, the rules on nano notification in the notified draft will be adopted in the form of a special amendment regulation to KIFS 2017:5.


8. Main Content
There are currently certain information requirements for those who notify products to the Swedish Chemicals Agency’s product register. The notified draft in question concerns the introduction of a requirement that the notifier – in addition to the information presently registered – also provide information on nanomaterial(s) contained in the product. It is proposed that this shall apply to nanomaterials which have been intentionally added to the product, regardless of the concentration of the nanomaterial(s).

It is proposed that the definition of nanomaterial shall reflect the European Commission’s recommended definition. Under this draft, however, nanomaterials that are natural or incidental shall not be notified to the product register. Exemption from the notification obligation is proposed for nanopigments and for entities with an annual turnover of less than SEK 5 million. Those covered by the exemption shall only provide information as to whether or not a component is a nanomaterial. Other information may be provided on a voluntary basis. It is proposed that these exceptions shall be valid for an evaluation period of three years. Under this draft, those product groups which are already exempt from the required registration in the product register will remain exempt. This is the case for waste, foodstuffs and animal feed, medicinal products, cosmetics and tattoo inks. The draft does not entail a registration obligation for nanomaterials in goods.


9. Brief Statement of Grounds
The aim of the draft is to establish an overview of the nanomaterials that are used in Sweden. The collected information will be usable for the identification of nanomaterials and, in turn, the keeping of statistics on nanomaterial usage. Such statistics can be used in, for example, oversight or as a basis for future regulatory development in the fields of health, the environment and occupational health and safety. They can also be used in trend analyses, the development of indicators, and follow-ups on environmental objectives and research.


10. Reference Documents - Basic Texts
Reference(s) to basic text(s): Ordinance (2008:245) on chemical products and biotechnological organisms.
Swedish Chemicals Agency's regulations (KIFS 2017:5) on chemical products and biotechnological organisms (planned date of adoption: 14 June 2017). These new basic regulations will eventually replace the current KIFS 2008:2. They shall enter into force on 1 September 2017. As regards the rules on notification of nanomaterials to the product register, specifically, the plan is for them to enter into force on 1 January 2018. The new rules on nano notification will be adopted in the form of a special amendment regulation to KIFS 2017:5, which will take place following completion of this EU legal procedure. This means that information on the presence of nanomaterials shall be reported to the Swedish Chemicals Agency’s product register, starting with the reporting that is to take place in February 2019.


11. Invocation of the Emergency Procedure
No


12. Grounds for the Emergency
-


13. Confidentiality
No


14. Fiscal measures
No


15. Impact assessment
Yes


16. TBT and SPS aspects
TBT aspect

No - the project has no significant impact on international trade.

SPS aspect

No - the draft is neither a sanitary nor phytosanitary measure.

**********
European Commission

Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
email: grow-dir83-189-central@ec.europa.eu

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