SNV

Neue Technische Vorschriften in der Vernehmlassung

Im Rahmen des Notifikationsverfahrens der EU/EFTA und der WTO/TBT informieren wir Sie über neu geplante technische Vorschriften. Wenn Sie der Auffassung sind, dass diese zu Schranken im grenzüberschreitenden Handel führen könnten, erhalten Sie hiermit Gelegenheit, dazu in englischer Sprache bis zu den angegebenen Fristen Stellung zu nehmen.

Stellungnahmen sind an folgende Adresse zu richten: Staatssekretariat für Wirtschaft (SECO), Aussenwirtschaftlicher Fachdienst Nichttarifarische Massnahmen (AFNT), Effingerstrasse 1, 3003 Bern.

Der vollständige Notifikationstext kann in der verfügbaren Sprache bei der SNV-Geschäftsstelle bezogen werden:
E-Mail: switecsnv.ch, Tel.: +41 52 224 54 55.

Die über 3000 jährlich publizierten Notifikationen finden Sie in unserer laufend aktualisierten Datenbank. Das SNV-News-Redaktionsteam möchte diesen Monat vor allem auf folgende neue Vorschriften hinweisen:

Nummer/Land Titel Inhalt Einspruchsfrist
BRA/440 Brazil Draft Resolution nº 34, June 28th 2011 – Used, refurbished, rented and lent medical devices (6 pages, Portuguese) This draft resolution regulates used, refurbished, rented and lent medical devices that must be registered at Anvisa according to Resolutions RDC 185/2001 and RDC 24/2009. Medical devices that are covered by this Resolution are, including their parts and accessories: - devices used for medical, dental, laboratorial and physical therapeutic purposes, directly or indirectly used for diagnosis, treatment, rehabilitation and humans monitoring. - devices used for beauty and esthetic purposes. Import, marketing, commercialization, exchange, donation and sale of used medical devices are forbidden in Brazilian territory, unless the medical devices have been through a process of reconditioning, according to the criteria established in this Technical Regulation. This resolution will revoke resolution RDC nº 25, 15 February 2001. 2011-09-01
EEC/383
European Union

 Draft Commission Regulation laying down common airspace usage requirements and operating procedures for airborne collision avoidance (7 pages, in English). The objective of this proposal is to increase significantly the safety of flights and to protect human lives. The draft regulation imposes common safety requirements both on EU registered aircraft and third country aircraft operated in the EU by introducing a new software version of the airborne collision avoidance system (ACAS II) to avoid mid-air collision to all aircraft flying to, within and out of the airspace to which the draft regulation applies. 2011-08-29
EEC/384
European Union
 Proposal for a Regulation of the European Parliament and of the Council on food intended for infants and young children and on food for special medical purposes (28 pages, in English). The proposal revises the legislation on foodstuffs for particular nutritional uses (dietetic foods). The proposal repeals Directive 2009/39/EC and abolishes the concept of dietetic foods. A number of the categories of foods currently covered by Directive 2009/39/EC will be in the future solely covered by other already existing pieces of food legislation. However, for foods intended to vulnerable groups of the population who need particular protection –namely infants and young children up to three years old and people with specific medical conditions, the proposal strengthens and clarifies the current provisions applying to these foods. It does so by maintaining the existing composition and labelling rules applicable to infant-formulae, follow-on formulae, processed-cereal based foods and other baby foods and foods for special medical purposes. Further, the proposal establishes a single EU list of substances (vitamins, minerals and other substances), instead of three, that can be added to these foods. The new framework will result in less administrative burden, more clarity and consistency within the EU and consequently allow for more flexibility for the evolving, innovative food market. No products will have to be withdrawn from the market, only the re-labelling of certain products might be necessary. A two-year transitional period is foreseen to reduce potential associated costs. 2011-10-20
EEC/381
European Union
 Draft Commission Regulation on electronic instructions for use of medical devices. The draft Regulation sets out conditions according to which instructions for use in paper form may be replaced by electronic instructions for use. It limits the possibility of providing instructions for use in electronic form to defined medical devices and accessories intended to be used in specific conditions. Furthermore, it contains a range of procedural safeguards. Thus instructions for use have to be provided in paper form on request, and a specific risk assessment by the manufacturer and information on how to access to the instructions for use is needed.
The draft Regulation also sets up a few basic safety requirements for:
- Instructions for use in electronic form which are provided in addition to complete instructions for use in paper form, and
- Websites containing such instructions for use.
 2011-08-08
EEC/385
European Union
 Draft Commission Regulation implementing Directive 2009/125/EC of the European Parliament and of the Council with regard to ecodesign requirements for household tumble driers (14 pages, in English). This draft Commission Regulation sets minimum energy performance, condensation efficiency and information requirements for household tumble driers. In accordance with the framework Directive 2009/125/EC, products not meeting these requirements will not be allowed to be placed on the EU market.
The draft Regulation is based on the findings of a technical, environmental and economic study which has been carried out with stakeholders from around the world.
 2011-09-20
EEC/386
European Union
 Draft Commission Delegated Regulation supplementing Directive 2010/30/EU of the European Parliament and of the Council with regard to energy labelling of household tumble driers (23 pages, in English). The draft Commission Delegated Regulation establishes requirements for the energy labelling and the provision of product information of household electric and gas fired tumble driers. It will repeal Commission Directive 95/13/EC of 23 May 1995 implementing Council Directive 92/75/EEC (revised by 2010/30/EU) with regard to energy labelling of household electric tumble driers. 2011-09-20
EEC/390
European Union

 Draft Commission Regulation amending Annex XIV of Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (8 pages, in English). This draft Commission Regulation aims at amending Annex XIV of the REACH Regulation. Annex XIV lists the substances which are subject to the authorisation requirement laid down in Title VII of the Regulation. The draft proposes to include eight additional substances in that Annex, namely diisobutyl phthalate, diarsenic trioxide, diarsenic pentaoxide, lead chromate, lead sulfochromate yellow, lead chromate molybdate sulphate red, tris (2-chloroethyl) phosphate and 2,4-dinitrotoluene. Once the regulation is adopted and enters into force, the placing on the market and the use of those substances in the EU will only be possible, after the date specified for each substance ("sunset date"), for those operators who have been granted an authorisation in accordance with Articles 60-64 of REACH, and for those who have submitted an application for authorisation before a given date ("latest application date") but a decision has not yet been adopted. 2011-09-27
KOR/314
Republic of KOREA
 Amendment of the Cosmetic Act (13 pages, in Korean). Amendment of labelling requirements:
- to determine mandatory information to be presented on the primary or secondary package of cosmetic products, and
- to require cosmetic product manufacturers to inscribe the name of the product, name of the manufacturer and the marketing authorization holder, manufacturing lot number, and the date of minimum durability or the period of time after opening (if this is the case, date of manufacture should be marked in parallel) on the primary package
 2011-09-15

Technische Vorschriften als PDF-Download