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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
2011/0284/B
Belgium		 Technical requirements for registered cash register systems (cash register system and peripheral control module) for use in hospitality establishments where meals are commonly consumed on site. From 1 January 2013, establishments where meals are provided must issue a VAT cash receipt produced by a registered cash register system. To guarantee the integrity and tamper-proofness of transaction data, such cash register systems shall be fitted with a peripheral control module, which stores and encrypts the relevant transaction data from the cash register system.
Requirements shall be imposed on the cash register system proper (including both mandatory and prohibited functionalities, mandatory layout of certain cash receipts); these requirements are largely within the parameter range of current systems, or else can be developed with relative ease.
The control module is a new product which does not exist yet, and will also be subject to strict technical requirements.		 2011-09-16
CHN/821
China
 Guidance for Application and Evaluation of New Cosmetic Ingredients. This guidance specifies the requirements for application and evaluation of new cosmetic ingredients. 2011-08-08
CHN/826
China
 National Standard of the P.R.C., Information Technology Equipment - Safety-Part 1: General Requirements. This standard applies to the information technology equipment with rated voltage not more than 600V for grid or battery power supply, including electrical affairs equipment and related equipments. 2011-08-16
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
2011/0280/D
Germany
 Assessment of substances with a specific technological function and low required quantities relating to the formulation review in accordance with the guidelines of the Federal Environment Agency on the hygienic assessment of organic materials in contact with drinking water (De Minimis Guideline). In the construction or maintenance of installations for the production or distribution of water destined for human use, only those materials may be used which do not release substances into the water in higher concentrations than those considered inevitable according to generally accepted technical standards, or which directly or indirectly affect the protection of human health or modify the smell or taste of the water. The proposed draft specifies these requirements. Substances not included in the whitelist shall be subject to requirements regarding the substances used as well as the products. 2011-09-12
PER/34
Peru
 Sanitary Directive governing the submission of the technical information on effectiveness and safety required for the registration of medicines classified under point 2 and the re registration of medicines classified under points 2 and 3 of Article 10 of Law No. 29459 The notified Directive contains eight sections. It establishes and defines the technical criteria for the technical information on effectiveness and safety required for the registration of category 2 medicines and the re registration of category 2 and 3 medicines, as provided for in Article 10 of Law No. 29459 on Pharmaceutical products, medical devices and sanitary products. 2011-08-29
PER/35
Peru
 Sanitary Directive governing the submission of the studies and other documents that substantiate the effectiveness and safety of products classified under point 3 of Article 10 of Law No. 29459 The notified Directive contains nine sections and an Annex. It establishes and defines technical criteria for the submission of the studies and other documents that substantiate the effectiveness and safety of medicines classified as category 3 under Article 10 of Law No. 29459 "Pharmaceutical products, medical devices and sanitary products" that are seeking to obtain sanitary registration. 2011-08-29

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