Issue of comments by: UNITED KINGDOM, ÉIRE/IRELAND
Issue of a detailed opinion by: CESK´A REPUBLIKA, COMMISSION, ITALIA
The issue of a detailed opinion extends the standstill period.
Draft Text :
To consult the full text of the draft proposal, please click on one of the language links below :
Impact assessment :
please click on one of the language links below :
Final Text :
To consult the information concerning the final text, please click on one of the language links below :
Notification Message Text :
To consult the notification text in another language, please click on one of the language links below :
Communication from the Commission - TRIS/(2013) 01751
Translation of the message 001
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 - Nao 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.
1. Structured Information Line
MSG 002 IND 2013 0369 B EN 04-07-2013 B NOTIF
2. Member State
3. Department Responsible
SPF Economie, PME, Classes moyennes et Energie
Direction générale Qualité et Sécurité - Service Normalisation et Compétitivité - BELNotif
NG III – 5ème étage
Boulevard du Roi Albert II, 16
B - 1000 Bruxelles
3. Originating Department
SPF Santé publique, Sécurité de la Chaine alimentaire et Environnement
Service MRB Chemicals
Place Victor Horta, 10
Tel.: 02.524.96.07 (Gwennaëlle Maes, juriste) ou 02.524.96.72 (Juan Pineros, pilote du projet)
4. Notification Number
2013/0369/B - C00C
Royal Decree on the market placement of substances manufactured at the nanoscale
6. Products Concerned
Substances manufactured at the nanoscale, preparations containing such substances and articles incorporating these substances.
Substances manufactured at the nanoscale included in the scope of the legislation: a nanomaterial as defined in § 2 of the Commission recommendation of 18 October 2011 on the definition of nanomaterials, including the assimilation of fullerenes, graphene flakes and carbon nanotubes, but with the exception of non-chemically-modified natural substances, substances produced accidentally and substances whose fraction between one nanometer and one hundred nanometres is a by-product of human activity. Furthermore, pigments and - concerning the declaration of articles - carbon black, synthetic amorphous silica and precipitated calcium carbonate used as fillers are excluded from the scope of the legislation in question.
Finally, products which are already subject to regulations concerning nanomaterials are excluded from the scope of the draft legislation (example: biocides, foodstuffs, etc.).
7. Notification Under Another Act
8. Main Content
The draft legislation implements a register of substances manufactured at the nanoscale based on declarations of products containing such substances by the parties placing these products on the market.
To this end, the draft legislation mandates that substances manufactured at the nanoscale, and preparations containing them, be declared if more than 100 grams of these substances are placed on the market per year (the declaration covers the characteristics of the substances, the quantity of substances manufactured at the nanoscale placed on the market, the use of the preparation or substance concerned and the identity of professional purchasers and users).
The draft legislation also lays down an obligation to make a simplified declaration for articles incorporating a substance or substances manufactured at the nanoscale, as long as more than 100 grams are placed on the market per year and the article emits more than 0.1% of substances manufactured at the nanoscale when in use (only a reduced list is required of the characteristics of the substances manufactured at the nanoscale).
Provisions are laid down concerning data protection and confidentiality, as well as concerning research and development activities.
The draft additionally covers the mutual recognition of the numbers of any declarations made by non-Member States, thus reducing the impact of the draft legislation on the free movement of the products concerned.
9. Brief Statement of Grounds
This register is being set up with the aim of:
1° improving knowledge of the market, the characteristics of nanomaterials and the potential risks to humans of exposure to these substances;
2° ensuring transparency and boosting the public's and workers' confidence regarding these substances;
3° ensuring traceability and thus enabling authorities to intervene in the event of any risk to public health or worker safety;
4° implementing a knowledge base which might prove necessary to future European and national regulatory developments concerning these substances;
5° ensuring that this innovative technology develops in tune with the interests of health and safety.
10. Reference Documents - Basic Texts
References to basic texts: The Belgian Law of 21 December 1998 on product standards aimed at promoting sustainable production and consumption, environmental protection and health and safety
11. Invocation of the Emergency Prodecure
12. Grounds for the Emergency
14. Fiscal measures
16. TBT aspect
No - the draft is not a technical provision or a conformity assessment procedure.
No - the draft is not a sanitary or phytosanitary measure.
Contact point Directive 98/34
Fax: +32 229 98043
[HOME] [98/34 PROCEDURE] [WHO'S WHO] [DATABASE] [HELP] [LINKS]