| Italy |
ITA/24 |
Gemmological materials
Italy
Gemmological materials
The proposed act comprises 17 Articles divided into five Chapters. Chapter I - "Definitions" identifies the area of application of the act, as well as the definitions and terms used, prescriptions, prohibitions and forms of use of names. Chapter II - "General provisions" lays down the prohibition of importing, exporting, holding for sale, selling or distributing gratuitously the materials and products listed in Chapter I under a different name than those prescribed. Chapter III - "Operator responsibility, disputes, testing laboratories" imposes an obligation on sellers to issue a statement, at the purchaser's request, regarding the materials sold, the content of which is to be established in the act's implementing regulation; to describe the procedures for resolving disputes, including recourse to registered test laboratories included on a list held by the Chamber of Commerce with jurisdiction. Chapter
IV identifies offences punishable by a fine and the amount of such fines, which are multiplied by ten in the case of remote sales or sales outside commercial businesses, as well as suspension from operation of the business for fifteen days to six months in the event of repeated violations. Chapter V contains a mutual recognition clause, describes the nature and terms for adopting the act's implementing regulation and states that the act shall take effect sixty days from its publication in the Official Gazette of the Italian Republic. |
1/13/2012 |
2/20/2012 |
| Ukraine |
UKR/68 |
Food products containing or not containing genetically modified organisms, or produced with their use, do not contain GMOs
Ukraine
Food products containing or not containing genetically modified organisms, or produced with their use, do not contain GMOs
Draft Resolution foresees the labelling of inscription on the presence or absence of GMOs in the foodstuff. This Resolution will replace the Decree of the Cabinet of Ministers of Ukraine as of 13 May 2009 No 468 "On approval of the order of labelling (marking) of foodstuff which contain genetically modified organisms or produced with their use and put into circulation" and sets as invalid the Decree No 468 (Notification G/TBT/N/UKR/39).
Labelling (marking) of foodstuff containing GMOs or produced with their use, is done by the manufacturer (supplier) with the statement of relevant information.
In the list of foodstuff ingredients after each component containing GMOs or produced with their use, should be made the inscription "(with GMO)", indicating the name of the organism or to each such ingredient should be made the corresponding footnote. The inscription is done in the same font print as the list of ingredients.
Labelling (marking) of foodstuff containing GMOs or produced using GMOs and sold
without packaging or with packaging, the largest surface area of which is less than 10 square centimetres, is done by the seller by applying an appropriate text likewise on the labels next to the title of the foodstuff or on the packaging material by the font print with the size not less than 2 millimeters.
Labelling (marking) of foodstuff that do not contain GMOs and produced using agricultural products that do not contain GMOs is done by applying the inscription "GMO-free" by the font print with the size not less than 2 millimeters.
This Draft also sets that entities still can use packing materials and labels which are not in compliance with the requirements of resolution within 24 months from the date of enactment of this Resolution. |
1/23/2012 |
2/28/2012 |
| Switzerland |
CHE/140 |
Human and veterinary medicines
Switzerland
Human and veterinary medicines
Partial revision of the Ordinance on the simplified authorization procedure and the reporting obligation for medicines (VAZV). The VAZV contains the essential implementation instructions for Art. 14 let. f of the Law on Therapeutic Products (LTP). The VAZV includes rules regarding admission and simplified authorization of medicines as so-called orphan drugs (important drugs for rare diseases: Art. 14 para. 1 let. f LTP). It also outlines rules on the simplified authorization procedure for medicines with known active ingredients, hospital preparations, and drugs that are manufactured using a formula recognized by the Agency.
Major proposed revisions are as follows:
To introduce a few minor adjustments to the criteria for the designation of a medicinal product as an orphan medicinal product;
To maintain alignment with the latest revision of the LTP entered in force on 1 October 2010
To establish rules on the simplified authorization procedure for radiopharmaceuticals with well-established use. |
12/20/2011 |
3/1/2012 |
| Switzerland |
CHE/141 |
Human and veterinary medicines
Switzerland
Human and veterinary medicines
Partial revision of the Ordinance on the medicines authorization (AMZV). In the AMZV the Agency describes in detail the information and documentation that must be provided as part of an authorization application. The ordinance applies both to human and to veterinary medicines and outlines the elements of the authorization that need to be supported by scientific evidence. It also describes the requirements for labelling and package inserts.
Major proposed revisions are as follows:
- To introduce a legal basis for the requirement of safety features on the package of medicines. Those safety features should allow verification of the authenticity and identification of individual packages, and provide evidence in case of tampering.
- To introduce a legal basis for imposing measures of improvement to pharmaceutical companies with regard to the prevention of medication errors in hospitals and home- care settings (clear and legible labelling of medicines; use of techniques such as "tall man" -lettering to reduce the potential for error due to confounding drug names; etc.). |
1/10/2012 |
3/1/2012 |
| Ukraine |
UKR/67 |
Items and materials, including active and intelligent materials and articles intended for the contact with foodstuff
Ukraine
Items and materials, including active and intelligent materials and articles intended for the contact with foodstuff
Draft Law establishes a legal framework and harmonizes the legislation of Ukraine with EU in order to ensure effective functioning of the market for items and materials that directly or indirectly contact with foodstuff, and at the same time provides a basis for provision a high level of protection of the health and consumers interests in foodstuff safety. The bill sets general and specific requirements for the circulation of items and materials which contact with foodstuff, including active and intelligent materials and articles; creates organizational measures to ensure effective cooperation of all stakeholders in food safety sphere (consumers, the competent government authorities and operators of foodstuff market) and adequate protection of consumers health and interests. The draft Law introduces a list of substances permitted for use in the production of objects and materials and sets the procedure for inclusion and exclusion of substances from the following list, and requirements for labelling of the items and materials which contact with food, identical to the requirements of the European Union.
Draft Law doesn't apply to: items and materials that are supplied as antiques; shells or protective materials, including materials covering cheese crust, meat semi-manufactured products or fruits, which are the parts of foodstuff and can be consumed with it; fixed installations for centralized or private water supply. |
1/23/2012 |
3/1/2012 |
| Italy |
ITA/25 |
Wheel-tyre systems for cars
Italy
Wheel-tyre systems for cars
The draft decree consists of ten articles and five annexes.
- Articles 1 and 2 identify its scope and set out the definitions used in the decree.
- Article 3 provides for approval of the systems and describes the methods and procedures to be implemented to obtain it.
- Articles 4 to 8 set out requirements relating to: general characteristics of the systems; their construction and marking; installation on vehicles and subsequent updating of the logbook; checking the production conformity verification system applied at the manufacturing plants for the systems.
- Article 9 sets out the conditions and methods for the acknowledgement of systems approved by Member States of the European Union, Turkey or parties to the European Economic Area Agreement.
- Article 10 makes reference to provisions to be issued by the Directorate-General for Road Traffic to define the procedures for updating vehicle logbooks of specific vehicle types, for which the manufacturer has issued specific clearance for the installation of tyre sizes not provided for in the approval process, and establishes that existing provisions shall apply to any delays in adopting such measure.
The annexes are models relating to:
A. Approval of a wheel-tyre system;
B. Approval certificate;
C. Procedure for checking the suitability of a system for approval purposes;
D. Marking of the wheel;
E. Declaration of installation of the system on a vehicle. |
1/13/2012 |
3/2/2012 |
| Albania |
ALB/49 |
Energy labeling of household washing machines
Albania
Energy labeling of household washing machines
This Technical Regulation establishes requirements for the labelling of and the provision of supplementary product information on electric mains-operated household washing machines and electric mains-operated household washing machines that can also be powered by batteries, including those sold for non-household use and built-in household washing machines. This Technical Regulation shall not apply to household combined washer-driers. |
1/6/2012 |
3/6/2012 |
| United Kingdom |
GBR/23 |
Articles of precious metal
United Kingdom
Articles of precious metal
The key provision in the Order will amend the Hallmarking Act 1973 so as to widen the scope of the hallmarking operations of the UK Assay Offices to as to enable the setting up of overseas operations. The Offices will thus have the opportunity, currently denied them, to hallmark in locations other than in the UK.
We are therefore proposing to amend section 2(1) of the Hallmarking Act which defines the meaning of approved hallmarks by adding a further alternative in relation to marks struck outside the United Kingdom by an Assay Office. These marks are to be struck in the same manner as if carried out in the UK but with an assay office mark approved by the BHC. This will enable the Assay offices to mark offshore if they so wish.
We are also proposing to make related changes to the Hallmarking Act as follows:
- providing sponsors and manufacturers with a wider choice of sponsors' marks than the 1973 Act currently allows (Section 3(3));
- permitting articles of silver, gold and platinum to be coated with platinum without having to obtain the consent in writing of the relevant Assay Office (Section 5(5));
- making provision for the British Hallmarking Council to authorise an Assay Office to carry on its business outside the UK (Section 13(2)(e)). |
12/9/2011 |
3/9/2012 |
| Albania |
ALB/50 |
Footwear
Albania
Footwear
This Technical Regulation shall apply to the labelling of the materials used in the main components of footwear for sale to the consumer. |
1/24/2012 |
3/24/2012 |
| Albania |
ALB/51 |
Crystal glass
Albania
Crystal glass
This Technical Regulation establishes the standard methods of determination of chemical and physical properties, specific properties depending on Pb content, terminology and labelling possibilities. |
1/24/2012 |
3/24/2012 |
| Ukraine |
UKR/69 |
Organic products and raw materials
Ukraine
Organic products and raw materials
Draft Law sets main definitions, objectives of the state policy on organic production, measures on the implementation of the state policy on organic production, principles of organic production (general and specific), and authorities of central bodies in the sphere of organic production.
The draft law also determines basis for organic production, transition period, general requirements for the sale of organic products (raw materials), general requirements for the labelling of organic products (raw materials), certification of organic production, scientific and methodological support of organic production, international cooperation in the field of organic production. |
2/7/2012 |
3/26/2012 |
| Albania |
ALB/52 |
Labelling of household electric refrigerators
Albania
Labelling of household electric refrigerators
This Regulation establishes requirements for the labelling of and the provision of supplementary product information on electric mains-operated household refrigerating appliances with a storage volume between 10 and 1 500 litres. It shall apply to electric mains-operated household refrigerating appliances, including those sold for non-household use or for the refrigeration of items other than foodstuffs and including built-in appliances. |
1/27/2012 |
3/27/2012 |
| Czech Republic |
CZE/154 |
Road motor vehicle tyre pressure gauges, except for pressure gauges used exclusively for the measurement of tyre pressure by motor vehicle users
Czech Republic
Road motor vehicle tyre pressure gauges, except for pressure gauges used exclusively for the measurement of tyre pressure by motor vehicle users
This measure of a general nature stipulates metrological and technical requirements for specified measuring devices, including test methods for verifying specified measuring devices, which in this case are road motor vehicle tyre pressure gauges, except for pressure gauges used exclusively for the measurement of tyre pressure by motor vehicle users. |
12/21/2011 |
3/31/2012 |
| Czech Republic |
CZE/153 |
Laboratory measurement devices for the flow quantity of gas
Czech Republic
Laboratory measurement devices for the flow quantity of gas
General measure establishing metrological and technical requirements for specified measurement devices, including testing methods for validating the specified measurement devices, which in this case are laboratory measurement devices for the flow quantity of gas. |
12/21/2011 |
3/31/2012 |
| Czech Republic |
CZE/152 |
Electricity meters for measuring energy
Czech Republic
Electricity meters for measuring energy
This measure of a general nature stipulates metrological and technical requirements for specified measuring devices, including test methods for verifying specified measuring devices, which in this case are electricity meters. |
12/21/2011 |
3/31/2012 |
| Switzerland |
CHE/142 |
Telecommunication equipment: radio equipment and telecommunication terminal equipment
Switzerland
Telecommunication equipment: radio equipment and telecommunication terminal equipment
Partial revision of the Decree of the Federal Office for Communications on telecommunications installations (OOIT). Some radio interface regulations have also been updated to take in account changes occurred in the spectrum management. The term IMT-2000/UMTS has been replaced by MFCN (Mobile/Fixed Communications Networks) in some radio interface regulations. The radio interface regulation for point to multipoint applications in the frequency band 24.500 - 26.500 GHz has been withdrawn as foreseen. The 12750 - 13250 MHz frequency band may be used for point to point applications; the Satellite News Gathering (SNG) band 12.75 - 13.25 GHz, the Satellite interactive terminals (SIT), Very small aperture terminals (VSAT) and Mobile-satellite stations with RX band 10.70 - 11.70 GHz, the Satellite user terminals (SUT) RX band 17.70 - 19.70 GHz have a co-primary status with the fixed satellite service under the terms of sufficient geographical separation. The minimum link distance for point to point fixed links application operated in a defined region south of the Alps in the frequency bands 17.7 - 19.7 GHz, 27.9405 - 29.4525 GHz has been reduced. Conditions for the operation of PMR applications in shielded rooms (as production studios) have been defined in the
frequency band 470 - 518 MHz. Beside the maximum output power inside the shielded room, the maximum radiated power outside the shielded room has also been defined. A license is mandatory. New, AIS maritime equipment may be used with a license in Switzerland on the Rhine between Rheinfelden and Kembs. The use of such equipment remains forbidden in the rest of the country. According the revised annex 12 of the ERC/REC 70-03, the frequency band 2483.5 - 2500 MHz can be used for low power active medical implants (LP-AMI) and associated peripherals. The use is license free. The reference to the ECC decision ECC/DEC/(06)12 for UWB devices in the frequency band 1600 - 10600 MHz for communication applications has been deleted because this decision has been replaced by ECC/DEC/(06)04 that was already mentioned. |
1/27/2012 |
4/1/2012 |
| France |
FRA/133 |
Alcohol breath-testing devices (breathalyzers)
France
Alcohol breath-testing devices (breathalyzers)
The notified draft Order updates existing regulations so as to take into account standards-related developments concerning breathalyzers. |
1/26/2012 |
4/11/2012 |
| Switzerland |
CHE/143 |
Receptacles for the transport of dangerous goods by road, rail and cableway
Switzerland
Receptacles for the transport of dangerous goods by road, rail and cableway
The ordinance: (1) regulates the placing on the market, the conformity assessment, the reassessment of conformity, periodic and intermediate inspections, exceptional checks and the market surveillance of dangerous goods receptacles. The term receptacles stands for all packaging, containers, tanks etc. which are allowed to be used for the transport of dangerous goods according to the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) and the Regulations concerning the International Carriage of Dangerous Goods by Rail (RID). With regard to "transportable pressure equipment" (definition according to Directive 2010/35/EU) the ordinance follows closely the European Directive 2010/35/EU. With respect to the other dangerous goods receptacles the principles of the Directive 2010/35/EU are applied to type approval, supervision of manufacture, initial inspection and tests, periodic inspection in accordance with the European Directive 2008/68/EC and ADR/RID respectively.
The ordinances (2) and (3) have to be revised to determine the notifying authorities and the competent authority for the market surveillance. Ordinance (2) is fully revised; Ordinance (3) is partially revised.
With the new ordinance (1) and the two revised ordinances (2) and (3) equivalent legislation between Switzerland and the EU is created within the scope of the Directive 2010/35/EU |
2/6/2012 |
5/31/2012 |
| Ukraine |
UKR/51 |
Machinery of all types, in particular - replaceable parts, replaceable parts of transmission, unaccomplished machinery, lifting machines, safety devices.
Ukraine
Machinery of all types, in particular - replaceable parts, replaceable parts of transmission, unaccomplished machinery, lifting machines, safety devices.
The proposed Technical Regulation establishes general requirements for machinery and equipment in order to protect human health and environment as well as the procedure of conformity of machinery and equipment and their maintenance. |
12/15/2010 |
6/1/2012 |
| European Communities |
EEC/412 |
Inland waterway vessels
European Communities
Inland waterway vessels
This draft Commission Directive amending technical requirements for inland waterway vessels aims at revising and clarifying requirements about railings, stability and transitional provisions. It also contains provisions modernizing radar specifications. A series of new or revised administrative instructions on various subjects give clarification on how to interpret the regulations. More specifically:
In Annex II the draft measure incorporates revised requirements in chapter 7, reduction on regulations for navigation lights by referring to a standard, chapter 10.03 on fire extinguishers, chapter 11: safety at workstations provided by railings and on safe operations with cranes, chapter 14 on liquefied gas installations, chapter 15 on stability and fire-protection subject to passenger vessels, chapter 22a on the stability of crafts longer than 110 m and as result of changes a adaption of chapters 24 resp. 24a regarding transitional provisions.
The Appendix I of Annex II is amended with a new symbol for wearing a life jacket.
The Appendix II of Annex II is extended with several administrative instructions to inspection bodies for a proper interpretation of the regulations.
The Annex IX is revised since the parts on navigation lights are deleted and the parts on radar and rate-of-turn indicators is modernized. |
10/28/2011 |
12/28/2012 |
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