ISSN 1977-0677
doi:10.3000/19770677.L_2013.065.eng
Official Journal
of the European Union
L 65
English edition
Legislation
Volume 56
8 March 2013
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ISSN 1977-0677 doi:10.3000/19770677.L_2013.065.eng |
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Official Journal of the European Union |
L 65 |
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English edition |
Legislation |
Volume 56 |
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(1) Text with EEA relevance |
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EN |
Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period. The titles of all other Acts are printed in bold type and preceded by an asterisk. |
II Non-legislative acts
REGULATIONS
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8.3.2013 |
EN |
Official Journal of the European Union |
L 65/1 |
COMMISSION REGULATION (EU) No 195/2013
of 7 March 2013
amending Directive 2007/46/EC of the European Parliament and of the Council and Commission Regulation (EC) No 692/2008 as concerns innovative technologies for reducing CO2 emissions from light passenger and commercial vehicles
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information (1), and in particular Article 4(4), Article 5(3), and Article 8 thereof,
Having regard to Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive) (2), and in particular Article 39(2) thereof,
Whereas:
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(1) |
By Regulation (EU) No 171/2013 (3), the Commission amended Directive 2007/46/EC and Commission Regulation (EC) No 692/2008 of 18 July 2008 implementing and amending Regulation (EC) No 715/2007 of the European Parliament and of the Council on type-approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information (4) as concerns innovative technologies for reducing CO2 emissions from light passenger and commercial vehicles. That Regulation amended the models of the relevant documents used in the type-approval process. As a result, it is necessary to provide the Member States with an adequate period to adapt the corresponding forms. For reasons of legal certainty and clarity, it is appropriate to replace Regulation (EC) No 171/2013. |
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(2) |
Regulation (EC) No 715/2007 establishes common technical requirements for the type-approval of motor vehicles and replacement parts with regard to their emissions and lays down rules for in-service conformity, durability of pollution control devices, on-board diagnostic (OBD) systems, measurement of fuel consumption and accessibility of vehicle repair and maintenance information. |
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(3) |
Regulation (EC) No 692/2008 lays down the administrative provisions for checking the conformity of the vehicles for CO2 emissions and the requirements for the measurement of CO2 emissions and fuel consumption of such vehicles. |
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(4) |
Regulation (EC) No 443/2009 of the European Parliament and of the Council (5) sets emission performance standards for new passenger cars as part of the integrated approach of the Union to reduce CO2 emissions from light-duty vehicles and Commission Implementing Regulation (EU) No 725/2011 (6) establishes a procedure for the approval and certification of innovative technologies for reducing CO2 emissions from such new passenger cars. |
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(5) |
In order to take account of the CO2 savings achieved through the use of innovative technologies for the calculation of each manufacturer’s specific emissions target of CO2 pursuant to Article 12(1) of Regulation (EC) No 443/2009, and in order to ensure efficient monitoring of the specific savings for individual vehicles, vehicles fitted with eco-innovations should be certified as part of the type-approval of a vehicle and the total savings should be entered into the certificate of conformity. |
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(6) |
To that end, it is necessary to provide the approval authorities with the adequate data for certifying vehicles fitted with eco-innovations and to integrate the CO2 savings of the eco-innovations as part of the representative information of a specific type, variant or version of vehicle. |
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(7) |
It is therefore necessary to amend the models of the relevant documents used in the type-approval process. |
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(8) |
Regulation (EC) No 715/2007 and Regulation (EC) No 595/2009 of the European Parliament and of the Council of 18 June 2009 on type-approval of motor vehicles and engines with respect to emissions from heavy duty vehicles (Euro VI) and on access to vehicle repair and maintenance information and amending Regulation (EC) No 715/2007 and Directive 2007/46/EC and repealing Directives 80/1269/EEC, 2005/55/EC and 2005/78/EC (7) introduced new requirements on information about pollutant emissions testing. Therefore, the necessary information should be incorporated in the system set up by Directive 2007/46/EC. |
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(9) |
Directive 2007/46/EC and Regulation (EC) No 692/2008 should therefore be amended accordingly. |
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(10) |
The measures provided for in this Regulation are in accordance with the opinion of the Technical Committee — Motor Vehicles, |
HAS ADOPTED THIS REGULATION:
Article 1
1. Annexes I and IX to Directive 2007/46/EC are amended in accordance with Annex I to this Regulation.
2. Annex VIII to Directive 2007/46/EC is replaced by the text set out in Annex II to this Regulation.
Article 2
Annexes I and XII to Regulation (EC) No 692/2008 are amended in accordance with Annex III to this Regulation.
Article 3
Regulation (EU) No 171/2013 is repealed.
Article 4
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 July 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 March 2013.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 171, 29.6.2007, p. 1.
(2) OJ L 263, 9.10.2007, p. 1.
(4) OJ L 199, 28.7.2008, p. 1.
ANNEX I
Annexes I and IX to Directive 2007/46/EC are amended as follows:
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(1) |
Annex I is amended as follows:
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(2) |
Annex IX is amended as follows:
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ANNEX II
‘ANNEX VIII
TEST RESULTS
(To be completed by the type-approval authority and attached to the vehicle EC type-approval certificate)
In each case, the information must make clear to which variant and version it is applicable. One version may not have more than one result. However, a combination of several results per version indicating the worst case is permissible. In the latter case, a note shall state that for items marked (*) only worst case results are given.
1. Results of the sound level tests
Number of the base regulatory act and latest amending regulatory act applicable to the approval. In case of a regulatory act with two or more implementation stages, indicate also the implementation stage:
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Variant/Version: |
… |
… |
… |
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Moving (dB(A)/E): |
… |
… |
… |
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Stationary (dB(A)/E): |
… |
… |
… |
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at (min– 1): |
… |
… |
… |
2. Results of the exhaust emission tests
2.1. Emissions from motor vehicles tested under the test procedure for light-duty vehicles
Indicate the latest amending regulatory act applicable to the approval. In case the regulatory act has two or more implementation stages, indicate also the implementation stage:
Fuel(s) (1) … (diesel, petrol, LPG, NG, Bi-fuel: petrol/NG, LPG, Flex-fuel: petrol/ethanol, NG/H2NG…)
2.1.1. Type 1 test (2) (3) (vehicle emissions in the test cycle after a cold start)
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Variant/Version: |
… |
… |
… |
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CO (mg/km) |
… |
… |
… |
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THC (mg/km) |
… |
… |
… |
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NMHC (mg/km) |
… |
… |
… |
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NOx (mg/km) |
… |
… |
… |
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THC + NOx (mg/km) |
… |
… |
… |
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Mass of particulate matter (PM) (mg/km) |
… |
… |
… |
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Number of particles (P) (#/km) (1) |
… |
… |
… |
2.1.2. Type 2 test (2) (3) (emissions data required at type-approval for roadworthiness purposes)
Type 2, low idle test:
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Variant/Version: |
… |
… |
… |
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CO (% vol.) |
… |
… |
… |
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Engine speed (min– 1) |
… |
… |
… |
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Engine oil temperature (°C) |
… |
… |
… |
Type 2, high idle test:
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Variant/Version: |
… |
… |
… |
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CO (% vol.) |
… |
… |
… |
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Lambda Value |
… |
… |
… |
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Engine speed (min– 1) |
… |
… |
… |
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Engine oil temperature (°C) |
… |
… |
… |
2.1.3. Type 3 test (emissions of crankcase gases): …
2.1.4. Type 4 test (evaporative emissions): …g/test
2.1.5. Type 5 test (durability of anti-pollution control devices):
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— |
Ageing distance covered (km)(e.g. 160 000 km): … |
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— |
Deterioration factor DF: calculated/fixed (1) |
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— |
Values:
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2.1.6. Type 6 test (average emissions at low ambient temperatures):
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Variant/Version: |
… |
… |
… |
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CO (g/km) |
… |
… |
… |
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THC (g/km) |
… |
… |
… |
2.1.7. OBD: yes/no (1)
2.2. Emissions from engines tested under the test procedure for heavy-duty vehicles.
Indicate the latest amending regulatory act applicable to the approval. In case the regulatory act has two or more implementation stages, indicate also the implementation stage:…
Fuel(s) (1) … (diesel, petrol, LPG, NG, ethanol …)
2.2.1. Results of the ESC test (2) (4) (5)
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Variant/Version: |
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… |
… |
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CO (mg/kWh) |
… |
… |
… |
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THC (mg/kWh) |
… |
… |
… |
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NOx (mg/kWh) |
… |
… |
… |
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NH3 (ppm) (1) |
… |
… |
… |
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PM mass (mg/kWh) |
… |
… |
… |
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PM number (#/kWh) (1) |
… |
… |
… |
2.2.2. Result of the ELR test (2)
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Variant/Version: |
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… |
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Smoke value:…m– 1 |
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… |
… |
2.2.3. Result of the ETC test (4) (5)
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Variant/Version: |
… |
… |
… |
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CO (mg/kWh) |
… |
… |
… |
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THC (mg/kWh) |
… |
… |
… |
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NMHC (mg/kWh) (1) |
… |
… |
… |
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CH4 (mg/kWh) (1) |
… |
… |
… |
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NOx (mg/kWh) |
… |
… |
… |
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NH3 (ppm) (1) |
… |
… |
… |
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PM mass (mg/kWh) |
… |
… |
… |
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PM number (#/kWh) (1) |
… |
… |
… |
2.2.4. Idle test (2)
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Variant/Version: |
… |
… |
… |
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CO (% vol.) |
… |
… |
… |
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Lambda Value (1) |
… |
… |
… |
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Engine speed (min– 1) |
… |
… |
… |
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Engine oil temperature (°C) |
… |
… |
… |
2.3. Diesel smoke
Indicate the latest amending regulatory act applicable to the approval. In case the regulatory act has two or more implementation stages, indicate also the implementation stage:
2.3.1. Results of the test under free acceleration
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Variant/Version: |
… |
… |
… |
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Corrected value of the absorption coefficient (m– 1) |
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… |
… |
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Normal engine idling speed |
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… |
… |
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Maximum engine speed |
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… |
… |
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Oil temperature (min./max.) |
… |
… |
… |
3. Results of the CO2 emission, fuel/electric energy consumption, and electric range tests
Number of the base regulatory act and the latest amending regulatory act applicable to the approval:
3.1. Internal combustion engines, including not externally chargeable hybrid electric vehicles (NOVC) (2) (6)
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Variant/Version: |
… |
… |
… |
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CO2 mass emission (urban conditions) (g/km) |
… |
… |
… |
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CO2 mass emission (extra-urban conditions) (g/km) |
… |
… |
… |
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CO2 mass emission (combined) (g/km) |
… |
… |
… |
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Fuel consumption (urban conditions) (l/100 km) (7) |
… |
… |
… |
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Fuel consumption (extra-urban conditions) (l/100 km) (7) |
… |
… |
… |
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Fuel consumption (combined) (l/100 km) (7) |
… |
… |
… |
3.2. Externally chargeable hybrid electric vehicles (OVC) (2)
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Variant/Version: |
… |
… |
… |
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CO2 mass emission (Condition A, combined) (g/km) |
… |
… |
… |
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CO2 mass emission (Condition B, combined) (g/km) |
… |
… |
… |
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CO2 mass emission (weighted, combined) (g/km) |
… |
… |
… |
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Fuel consumption (Condition A, combined) (l/100 km) (g) |
… |
… |
… |
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Fuel consumption (Condition B, combined) (l/100 km) (g) |
… |
… |
… |
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Fuel consumption (weighted, combined) (l/100 km) (g) |
… |
… |
… |
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Electric energy consumption (Condition A, combined) (Wh/km) |
… |
… |
… |
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Electric energy consumption (Condition B, combined) (Wh/km) |
… |
… |
… |
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Electric energy consumption (weighted and combined) (Wh/km) |
… |
… |
… |
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Pure electric range (km) |
… |
… |
… |
3.3. Pure electric vehicles (2)
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Variant/Version: |
… |
… |
… |
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Electric energy consumption (Wh/km) |
… |
… |
… |
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Range (km) |
… |
… |
… |
3.4. Hydrogen fuel cell vehicles (2)
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Variant/Version: |
… |
… |
… |
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Fuel consumption (kg/100 km) |
… |
… |
… |
4. Results of the tests for vehicles fitted with eco-innovation(s) (1) (2) (3)
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Variant/Version … |
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Decision approving the eco-innovation (4) |
Code of the eco-innovation (5) |
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CO2 emissions savings
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xxxx/201x |
… |
… |
… |
… |
… |
… |
… |
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… |
… |
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… |
… |
… |
… |
… |
… |
… |
… |
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Total CO2 emissions savings (g/km) (7) |
… |
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4.1. General code of the eco-innovation(s) (8)
Explanatory notes
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(h) |
Eco-innovations. |
(1) When restrictions for the fuel are applicable, indicate these restrictions (e.g. for natural gas the L range or the H range).
(2) For bi fuel vehicles, the table shall be repeated for both fuels.
(3) For flex fuel vehicles, when the test is to be performed on both fuels, according to Figure I.2.4 of Annex I to Regulation (EC) No 692/2008, and for vehicles running on LPG or NG/Biomethane, either bi-fuel or mono-fuel, the table shall be repeated for the different reference gases used in the test, and an additional table shall display the worst results obtained. When applicable, in accordance with sections 1.1.2.4 and 1.1.2.5 of Annex I to Regulation (EC) No 692/2008, it shall be shown if the results are measured or calculated.
(1) Delete where not applicable.
(2) If applicable.
(4) For Euro VI, ESC shall be understood as WHSC and ETC as WHTC.
(5) For Euro VI, if CNG and LPG fuelled engines are tested on different reference fuels, the table shall be reproduced for each reference fuel tested.
(6) Repeat the table for each reference fuel tested.
(7) The unit “l/100 km” is replaced by “m3/100 km” for vehicles fuelled with NG and H2NG, and by “kg/100 km” for vehicles fuelled with hydrogen.
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(h1) |
Repeat the table for each variant/version. |
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(h2) |
Repeat the table for each reference fuel tested |
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(h3) |
Expand the table if necessary, using one extra row per eco-innovation. |
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(h4) |
Number of the Commission Decision approving the eco-innovation. |
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(h5) |
Assigned in the Commission Decision approving the eco-innovation. |
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(h6) |
If a modelling methodology is applied instead of the type 1 test cycle, this value shall be the one provided by the modelling methodology. |
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(h7) |
Sum of the CO2 emissions savings of each individual eco-innovation. |
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(h8) |
The general code of the eco-innovation(s) shall consist of the following elements each separated by a blank space:
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ANNEX III
Annexes I and XII to Regulation (EC) No 692/2008 are amended as follows:
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(1) |
Annex I is amended as follows:
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(2) |
in Annex XII the following points 4, 4.1, 4.2, 4.3 and 4.4 are added: ‘4. TYPE-APPROVAL OF VEHICLES FITTED WITH ECO-INNOVATIONS 4.1. According to Article 11(1) of Implementing Regulation (EU) No 725/2011, a manufacturer wishing to benefit from a reduction of its average specific CO2 emissions, as result of the savings achieved by one or more eco-innovations fitted in a vehicle, shall apply to an approval authority for an EC type-approval certificate of the vehicle fitted with the eco-innovation. 4.2. The CO2 emissions savings from the vehicle fitted with an eco-innovation shall, for the purpose of type-approval, be determined using the procedure and testing methodology specified in the Commission Decision approving the eco-innovation, in accordance with Article 10 of Implementing Regulation (EU) No 725/2011. 4.3. The performance of the necessary tests for the determination of the CO2 emissions savings achieved by the eco-innovations shall be considered without prejudice to the demonstration of compliance of the eco-innovations with the technical prescriptions laid down in Directive 2007/46/EC, if applicable. 4.4. The type-approval shall not be granted if the eco-innovation vehicle does not show a minimum of 1 gCO2/km of emissions reduction with respect to the baseline vehicle, as referred to in Article 5 of Implementing Regulation (EU) No 725/2011.’. |
(*1) OJ L 140, 5.6.2009, p. 1.
(*2) OJ L 194, 26.7.2011, p. 19.’;
(*3) Delete where not applicable.
(*4) If applicable.
(*5) Repeat the table for each reference fuel tested.
(*6) Expand the table if necessary, using one extra row per eco-innovation.’;
(*7) Repeat the table for each reference fuel tested.
(*8) Expand the table if necessary, using one extra row per eco-innovation.
(*9) The general code of the eco-innovation(s) shall consist of the following elements, each separated by a blank space:’
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— |
Code of the type-approval authority as set out in Annex VII to Directive 2007/46/EC; |
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— |
Individual code of each eco-innovation fitted in the vehicle, indicated in chronological order of the Commission approval decisions. (E.g. the general code of three eco-innovations approved chronologically as 10, 15 and 16 and fitted to a vehicle certified by the German type approval authority should be: “e1 10 15 16”)’. |
(1) Number of the Commission Decision approving the eco-innovation.
(2) Assigned in the Commission Decision approving the eco-innovation.
(3) Under agreement of the type-approval authority, if modelling is applied instead of the type 1 test-cycle, this value shall be the one provided by the modelling methodology.
(4) Sum of the emissions saving of each individual eco-innovation.
(5) Number of the Commission Decision approving the eco-innovation.
(6) Assigned in the Commission Decision approving the eco-innovation.
(7) If modelling is applied instead of the type 1 test-cycle, this value shall be the one provided by the modelling methodology.
(8) Sum of the emissions saving of each individual eco-innovation.
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8.3.2013 |
EN |
Official Journal of the European Union |
L 65/13 |
COMMISSION IMPLEMENTING REGULATION (EU) No 196/2013
of 7 March 2013
amending Annex II to Regulation (EU) No 206/2010 as regards the new entry for Japan in the list of third countries or parts thereof from which imports into the European Union of certain fresh meat are authorised
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (1), and in particular the introductory phrase of Article 8, the first subparagraph of point (1) of Article 8 and point (4) of Article 8 thereof,
Whereas:
|
(1) |
Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (2) establishes sanitary conditions for the import of live animals and fresh meat thereof. According to Regulation (EU) No 206/2010 fresh meat intended for human consumption can only be imported if it comes from a territory of a third country or a part thereof listed in Part 1 of Annex II to that Regulation and meets the relevant requirements. |
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(2) |
Japan requested to be listed for the import of fresh bovine meat into the Union and the Commission audit on bovine meat in Japan in 2008 confirmed that the requirements were met. The listing was, however, postponed when foot-and-mouth disease occurred in Japan in 2010. |
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(3) |
Since then Japan eradicated the foot-and-mouth disease on its territory and was recognised as ‘free without vaccination’ for this disease by the World Organisation for Animal Health (OIE). |
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(4) |
Japan thus provides sufficient animal health guarantees and has asked again to be included in the list of third countries authorised for the import of fresh bovine meat into the Union. |
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(5) |
Japan should thus be allowed to import fresh bovine meat into the Union. |
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(6) |
Part 1 of Annex II to Regulation (EU) No 206/2010 should therefore be amended accordingly. |
|
(7) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
HAS ADOPTED THIS REGULATION:
Article 1
In Part 1 of Annex II to Regulation (EU) No 206/2010, the following entry for Japan is inserted after the entry for Iceland:
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 March 2013.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 18, 23.1.2003, p. 11.
(*1) Meat from animals slaughtered on or before the date set out in column 7 may be imported into the Union for 90 days from that date. Consignments carried on vessels on the high seas may be imported into the Union if certified before the date set out in column 7 for 40 days from that date. (N.B.: no date in column 7 means that there are no time restrictions).
(*2) Only meat from animals slaughtered on or after the date set out in column 8 may be imported into the Union (no date in column 8 means that there are no time restrictions).
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8.3.2013 |
EN |
Official Journal of the European Union |
L 65/15 |
COMMISSION IMPLEMENTING REGULATION (EU) No 197/2013
of 7 March 2013
amending Implementing Regulation (EU) No 80/2012 establishing the list of biological or chemical substances provided for in Article 53(1)(b) of Council Regulation (EC) No 1186/2009 setting up a Community system of reliefs from custom duty
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Regulation (EC) No 1186/2009 of 16 November 2009 setting up a Community system of reliefs from customs duty (1), and in particular Article 53(1)(b) thereof,
Whereas:
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(1) |
Commission Implementing Regulation (EU) No 80/2012 (2) sets out the list of biological or chemical substances provided for in Article 53(1)(b) of Regulation (EC) No 1186/2009. |
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(2) |
Implementing Regulation (EU) No 80/2012 should be amended in order to include in the list two substances for which there is at present no equivalent production within the customs territory of the Union. |
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(3) |
Moreover, it is no longer necessary to maintain in the list a substance which is currently listed in Annex 3 to Part Three of Annex I to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (3) concerning the pharmaceutical substances which are free of duty. |
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(4) |
Implementing Regulation (EU) No 80/2012 should therefore be amended accordingly. |
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(5) |
The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee, |
HAS ADOPTED THIS REGULATION:
Article 1
Annex I to Implementing Regulation (EU) No 80/2012 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 March 2013.
For the Commission
The President
José Manuel BARROSO
ANNEX
Annex I to Implementing Regulation (EU) No 80/2012 is amended as follows:
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(1) |
the following row is inserted after the row containing the CN code ex 2845 90 90 for (Oxygen-18) Water:
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(2) |
the following row is inserted after the row containing the CN code ex 2926 90 95 for 2-Naphtonitrile:
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(3) |
the following row is deleted:
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8.3.2013 |
EN |
Official Journal of the European Union |
L 65/17 |
COMMISSION IMPLEMENTING REGULATION (EU) No 198/2013
of 7 March 2013
on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (1), and in particular Article 23(4) thereof,
Whereas:
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(1) |
Some medicinal products for human use are authorised subject to additional monitoring for reasons of their specific safety profile. Pursuant to Article 23 of Regulation (EC) No 726/2004 this includes medicinal products with a new active substance, biological medicinal products and products for which post-authorisation data are required. |
|
(2) |
Patients and healthcare professionals should be able to easily identify medicinal products that are subject to additional monitoring in order to allow them to share with the competent authorities and the marketing authorisation holder any information they have from the use of the medicinal product and in particular to report suspected adverse reactions. |
|
(3) |
To ensure transparency, all medicinal products that are subject to additional monitoring are included in a list that is set up and maintained by the European Medicines Agency in accordance with Article 23(1) of Regulation (EC) No 726/2004. Additionally, they are labelled with a black symbol. |
|
(4) |
On 3 October 2012 the Pharmacovigilance Risk Assessment Committee adopted a recommendation stating that the black symbol should be an inverted equilateral black triangle. The recommendation took into account the views of patients and healthcare professionals as expressed by the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Group established by the European Medicines Agency. |
|
(5) |
Holders of marketing authorisations that were granted before 1 September 2013 should be given sufficient time to adapt the product information of the products concerned. |
|
(6) |
In addition, competent authorities should be given the possibility to grant a longer period of time for that adaptation where exceptional circumstances so require. |
|
(7) |
The introduction of the black symbol should not cause difficulties on the market and in the supply chain. In order to avoid any disruptions, marketing authorisation holders should not be obliged to recall or repackage products which have been already placed on the market, |
HAS ADOPTED THIS REGULATION:
Article 1
The black symbol referred to in Article 23(4) of Regulation (EC) No 726/2004 shall be an inverted equilateral triangle. It shall comply with the model and the dimensions set out in the Annex to this Regulation.
Article 2
1. Holders of marketing authorisations granted before 1 September 2013 which concern medicinal products for human use that are subject to additional monitoring shall include the black symbol in the summary of product characteristics and the package leaflet relating to these medicinal products by 31 December 2013.
2. By derogation from paragraph 1, holders of marketing authorisations granted before 1 September 2013 which concern medicinal products for human use that are subject to additional monitoring may request a longer period of time to be granted by the competent authorities, where they can demonstrate that compliance with the date referred to in paragraph 1 may unduly affect the appropriate and continued supply of the medicinal product.
Article 3
Stocks of human medicinal products produced, packaged and labelled before 1 January 2014, which do not include the black symbol in the package leaflet may continue to be placed on the market, distributed, dispensed, sold and used until stocks are exhausted.
Article 4
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 March 2013.
For the Commission
The President
José Manuel BARROSO
ANNEX
|
1. |
The black symbol referred to in Article 23(4) of Regulation (EC) No 726/2004 shall comply with the following model:
|
|
2. |
The black symbol shall be proportional to the font size of the subsequent standardised text and each side of the triangle shall have a minimum length of 5 mm. |
|
8.3.2013 |
EN |
Official Journal of the European Union |
L 65/19 |
COMMISSION IMPLEMENTING REGULATION (EU) No 199/2013
of 7 March 2013
establishing the standard import values for determining the entry price of certain fruit and vegetables
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),
Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
Whereas:
|
(1) |
Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto. |
|
(2) |
The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union, |
HAS ADOPTED THIS REGULATION:
Article 1
The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 March 2013.
For the Commission, On behalf of the President,
José Manuel SILVA RODRÍGUEZ
Director-General for Agriculture and Rural Development
ANNEX
Standard import values for determining the entry price of certain fruit and vegetables
|
(EUR/100 kg) |
||
|
CN code |
Third country code (1) |
Standard import value |
|
0702 00 00 |
IL |
82,8 |
|
MA |
59,1 |
|
|
TN |
68,1 |
|
|
TR |
103,8 |
|
|
ZZ |
78,5 |
|
|
0707 00 05 |
EG |
191,6 |
|
MA |
170,1 |
|
|
TR |
151,3 |
|
|
ZZ |
171,0 |
|
|
0709 91 00 |
EG |
82,2 |
|
ZZ |
82,2 |
|
|
0709 93 10 |
MA |
47,9 |
|
TR |
122,6 |
|
|
ZZ |
85,3 |
|
|
0805 10 20 |
EG |
49,9 |
|
IL |
71,4 |
|
|
MA |
50,1 |
|
|
TN |
63,1 |
|
|
TR |
62,2 |
|
|
ZZ |
59,3 |
|
|
0805 50 10 |
TR |
86,7 |
|
ZZ |
86,7 |
|
|
0808 10 80 |
AR |
116,3 |
|
BR |
91,4 |
|
|
CL |
115,2 |
|
|
CN |
77,3 |
|
|
MK |
28,7 |
|
|
US |
168,2 |
|
|
ZZ |
99,5 |
|
|
0808 30 90 |
AR |
112,8 |
|
CL |
115,4 |
|
|
TR |
171,6 |
|
|
US |
191,0 |
|
|
ZA |
101,2 |
|
|
ZZ |
138,4 |
|
(1) Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘ ZZ ’ stands for ‘of other origin’.
DECISIONS
|
8.3.2013 |
EN |
Official Journal of the European Union |
L 65/21 |
DECISION OF THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES
of 6 March 2013
appointing Judges to the General Court
(2013/119/EU)
THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES OF THE EUROPEAN UNION,
Having regard to the Treaty on European Union, and in particular Article 19 thereof,
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 254 and 255 thereof,
Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 106a(1) thereof,
Whereas:
|
(1) |
The terms of office of 13 Judges of the General Court are due to expire on 31 August 2013. Judges should therefore be appointed for the period from 1 September 2013 to 31 August 2019. |
|
(2) |
It has been proposed that the terms of office of Ms Mariyana KANCHEVA, Ms Ingrīda LABUCKA, Mr Alfred DITTRICH and Mr Nicholas James FORWOOD as Judges of the General Court should be renewed. |
|
(3) |
The panel set up by Article 255 of the Treaty on the Functioning of the European Union has given its opinion on the suitability of Ms Mariyana KANCHEVA, Ms Ingrīda LABUCKA, as well as of Mr Alfred DITTRICH and Mr Nicholas James FORWOOD to perform the duties of Judge of the General Court, |
HAVE ADOPTED THIS DECISION:
Article 1
The following are hereby appointed Judges to the General Court from 1 September 2013 to 31 August 2019:
|
— |
Mr Alfred DITTRICH, |
|
— |
Mr Nicholas James FORWOOD, |
|
— |
Ms Mariyana KANCHEVA, |
|
— |
Ms Ingrīda LABUCKA. |
Article 2
This Decision shall enter into force on the day following its publication in the Official Journal of the European Union.
Done at Brussels, 6 March 2013.
The President
R. MONTGOMERY
|
8.3.2013 |
EN |
Official Journal of the European Union |
L 65/22 |
DECISION OF THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES
of 6 March 2013
appointing a Judge to the General Court
(2013/120/EU)
THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES OF THE EUROPEAN UNION,
Having regard to the Treaty on European Union, and in particular Article 19 thereof,
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 254 and 255 thereof,
Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 106a(1) thereof,
Whereas:
|
(1) |
Under Articles 5 and 7 of the Protocol on the Statute of the Court of Justice of the European Union and following the resignation of Mr Nils WAHL, a Judge should be appointed to the General Court for the remainder of Mr Nils WAHL's term of office, which runs until 31 August 2013. |
|
(2) |
Mr Carl WETTER has been proposed for the vacant post. |
|
(3) |
The panel set up by Article 255 of the Treaty on the Functioning of the European Union has given its opinion on Mr Carl WETTER’s suitability to perform the duties of a Judge of the General Court, |
HAVE ADOPTED THIS DECISION:
Article 1
Mr Carl WETTER is hereby appointed Judge to the General Court for the period from the date of the entry into force of this Decision to 31 August 2013.
Article 2
This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union.
Done at Brussels, 6 March 2013.
The President
R. MONTGOMERY
|
8.3.2013 |
EN |
Official Journal of the European Union |
L 65/23 |
COMMISSION DECISION
of 7 March 2013
on the safety requirements to be met by European standards for certain seats for children pursuant to Directive 2001/95/EC of the European Parliament and of the Council on general product safety
(Text with EEA relevance)
(2013/121/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (1), and in particular Article 4(1)(a) thereof,
Whereas:
|
(1) |
Products which conform to national standards that transpose European standards drawn up under Directive 2001/95/EC and referenced in the Official Journal of the European Union benefit from a presumption of safety. |
|
(2) |
European standards are to be drawn up on the basis of requirements intended to ensure that products which conform to them satisfy the general safety requirement set out in Article 3 of Directive 2001/95/EC. |
|
(3) |
European standards EN 14988-1:2006 (Part 1: Safety requirements) and EN 14988-2:2006 (Part 2: Test methods) for children’s high chairs need to be revised. In particular, more stringent safety requirements need to be introduced with regard to falling and entanglement hazards. |
|
(4) |
European standard EN 1272:1998 (Safety requirements and test methods) for table-mounted chairs is not referenced in the Official Journal of the European Union. As a consequence, national standards that transpose that European standard do not give rise to a presumption of safety. |
|
(5) |
No European standards exist for children’s chairs or for chair-mounted seats. |
|
(6) |
It is therefore appropriate to determine the requirements intended to ensure that such seats for children satisfy the general safety requirement set out in Article 3 of Directive 2001/95/EC. |
|
(7) |
The measures provided for in this Decision are in accordance with the opinion of the Committee on General Product Safety, |
HAS ADOPTED THIS DECISION:
Article 1
Definitions
For the purposes of this Decision, the following definitions apply:
|
(a) |
‘Chair-mounted seat’ means a product intended to be fixed onto an adult chair to raise the sitting position of a child up to 36 months old who is able to sit up unaided; |
|
(b) |
‘Children’s chair’ means a chair intended for seating one child, of a size adjusted to the child’s age and intended to be placed on the floor; |
|
(c) |
‘Children’s high chair’ means a free-standing chair that elevates the child from six months to 36 months of age to approximately dining-table height, intended for feeding a child who is able to sit up unaided, if the child is appropriately secured in the sitting position; |
|
(d) |
‘Table-mounted chair’ means a chair normally used for children who are able to sit up unaided that is intended to be attached to a table or other horizontal surface. |
Article 2
Safety requirements
The specific safety requirements for products referred to in Article 1, which are to be met by European standards referred to in Article 4(1) of Directive 2001/95/EC, are set out in the Annex to this Decision.
Article 3
Entry into force
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Done at Brussels, 7 March 2013.
For the Commission
The President
José Manuel BARROSO
ANNEX
GENERAL SAFETY REQUIREMENTS
When used as intended or in a foreseeable way and bearing in mind the behaviour of children, products must not jeopardise the safety or health of children and carers.
If one type of chair can be converted into another type of chair (for example, a high chair into a children’s chair), it must comply with safety requirements for both types of chairs.
Labels on the products or on their packaging and the accompanying instructions for use must draw the attention of users to the inherent hazards and risks of injuries involved in using the products and to ways of avoiding them. However, products need to be safe by design as far as possible, and therefore labels and warnings must not replace safety by design.
Chemical requirements
All products referred to in Article 1 must comply with EU legislation.
Flammable properties
Products referred to in Article 1 must not constitute dangerous instantly flammable elements in the child’s environment. They must therefore be made of materials that do not produce a flash effect if directly exposed to a flame or spark. For this reason, the latest version of EN 71-2 should be taken into account.
The use of chemical flame retardant substances should be kept to the minimum. If chemical flame retardant substances are used, their toxicity during use and their end-of-life disposal should not endanger the health of the user, the child’s carers or the environment.
Packaging
Bags made of flexible plastics that are used for packaging, and that have an opening perimeter larger than the circumference of a child’s head, must not put the child at risk of suffocation. The use of drawstrings or cords to close such packaging, or to close self-adhesive packaging (e.g. ‘cling-film’ type packaging) is prohibited.
The packaging that contains the products must not present a risk of suffocation caused by an obstruction of the mouth and nose. To this end, when not incompatible with moisture exclusion, plastic packaging should be perforated.
Bags must be conspicuously marked with the following warning or an equivalent warning: ‘WARNING! Keep packaging away from children to prevent them from suffocating’. They must also bear a large, clear symbol or diagram indicating that there is a potential hazard.
Identification of the manufacturer and importer
Manufacturers (1) must indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, when that is not possible, on its packaging or in a document accompanying the product. The address must indicate a single point at which the manufacturer can be contacted (2).
Importers (3) must indicate their name, registered trade name or registered trade mark and the address at which they can be contacted on the product or, when that is not possible, on its packaging or in a document accompanying the product (4).
SPECIFIC SAFETY REQUIREMENTS
1. CHAIR-MOUNTED SEATS
1.1. Scope
These safety requirements apply to chair-mounted seats intended for children up to the age of 36 months who weigh a maximum of 15 kg. They do not apply to cushions, pads and any products intended to restrain a child on a chair without raising the child’s sitting position.
1.2. Safety requirements
Entrapment hazards from gaps and openings
Chair-mounted seats must be designed and manufactured to prevent the entrapment of any part of a child’s body.
Hazards associated with adjusting the height of the chair-mounted seat
Chair-mounted seats in which the height of the sitting area can be adjusted must have locking mechanism(s) to secure the chair-mounted seat in its position of normal use. The unintentional release of locking mechanism(s) must be prevented.
Hazards associated with moving parts
Once the chair-mounted seat is set up for normal use, there must not be any accessible compression or shear points as a result of moving the chair-mounted seat or any part of it, the child’s shifting its body weight while in the chair-mounted seat, or the application of an external force (either by another child or, unintentionally, by the carer, or by a powered mechanism).
Chair-mounted seats designed to fold must have a folding mechanism that a child cannot operate and that a carer cannot inadvertently trigger. It must not be possible to set up chair-mounted seats for normal use without activating the locking mechanism.
Falling hazards
Once it is set up for normal use, the chair-mounted seat must ensure that the child remains in it and that it does not overturn when he or she leans in any direction. To avoid injuries due to the child’s standing up and falling or slipping out of the chair-mounted seat, it must be designed in such a way that its restraint system prevents the child from standing up and falling or slipping out of it.
The chair-mounted seat must be fitted with a restraint system that can be adjusted to the size of the child and must consist of at least a waist and crotch restraint. It must not be possible to use the restraint system without using the crotch restraint.
The restraint system, straps, anchoring points and fastening system must suffer no permanent damage which can impair their safety and normal function when subjected to static and dynamic mechanical stress during reasonable foreseeable use of the chair-mounted seat.
When mounted for use, the height of the backrest of the chair-mounted seat must be appropriately high. It must also be fitted with side armrests that are high enough to ensure that a child remains in the seat when he or she leans in any direction.
Entanglement hazards
Cords, ribbons and similar parts, except the child restraint system and chair attachment system, that are accessible from inside the chair-mounted seat, must have a maximum free length that prevents a hazardous loop from forming around a child’s neck.
Monofilament threads must not be used as cords, ribbons and similar parts, as loops or as sewing threads.
Choking hazards
To prevent choking hazards, chair-mounted seats must not contain any small parts, whether intended to be removed without a tool or not, that could become detached by forces that a child can apply and are small enough to fit entirely in a child’s mouth.
Stuffing materials that constitute choking hazards must not become accessible when submitted to the forces that a child can apply. They must not constitute an additional choking hazard due to the size of the elements they contain or because these elements become sufficiently small or accessible when submitted to the forces that a child can apply.
Ingestion hazards
To avoid the hazard of ingestion, chair-mounted seats must not contain separate or small parts that are detachable by forces that a child can apply and can pass through the child’s oesophagus. In any case, toxic materials or surfacing must not be used.
Suffocation hazards
Chair-mounted seats must not have any plastic decals that could be gripped by a child and detached by forces that a child can apply. They must not have any impermeable sheeting that could cover both the mouth and the nose of the child and thus constitute suffocation hazards.
Hazardous edges, corners and protruding parts
All accessible edges, corners and protruding parts of the chair-mounted seat must be rounded and they must not contain burrs or sharp edges.
Surfaces
All surfaces must, to the extent compatible with the functions of the chair-mounted seat, be smooth enough to prevent abrasions, cuts, scratches, grazes, burns or other injuries which might be caused incidentally while the chair-mounted seat is in use or by a child’s behaviour.
Structural integrity
The chair-mounted seat must not collapse or show any sign of damage or permanent deformation which can impair its safety and normal function. Any mechanism(s) for adjusting the height of the chair-mounted seat must not allow the height position chosen to be changed due to mechanical stress to which the chair-mounted seat is subjected during reasonable foreseeable use.
Chair attachment system
The chair attachment system must be designed to fix the chair-mounted seat both to the backrest and to the seat surface of the chair.
The chair attachment system, straps, anchoring points and fastening system must not break, become loose or tear away from their support due to mechanical stress to which they are subjected during reasonable foreseeable use.
Hazards associated with inadequate size
The product information must specify the adequate dimensions of the seat and of the backrest of the chairs for which the product is intended.
1.3. Safety information, user manual and markings
Safety information must be marked on the product and included in the instructions to the user.
Safety information must be given in writing in the language(s) of the country in which the chair-mounted seat is offered for retail sale and in self-explanatory pictograms. All markings must remain legible and any label used for the markings must not come off easily.
Safety information
Essential safety information must be provided, in a clear and conspicuous way. It must be clearly displayed and remain visible after attaching the chair-mounted seat to the adult chair and before the child is placed in the chair-mounted seat. The information must be labelled ‘WARNING!’ and must convey at least the following messages or equivalent messages:
|
— |
‘Never leave the child unattended.’ |
|
— |
‘Always use the child restraint and chair attachment systems.’ |
|
— |
‘Always check the security and the stability of the chair-mounted seat before use.’ |
|
— |
‘This product is intended for children up to 36 months old, weighing a maximum of 15 kg, who are able to sit up unaided.’ |
Purchase information
The consumer must be able to clearly see the purchase information at the point of sale. It must contain at least the following, both in writing and in a self-explanatory pictogram:
|
— |
this statement or an equivalent statement: ‘This product is intended for children up to 36 months old, weighing a maximum of 15 kg, who are able to sit up unaided.’, |
|
— |
the adequate dimensions of the adult chair, seat and backrest. |
User manual
The chair-mounted seat must come with a user manual. The user manual must contain:
|
— |
the following statement or an equivalent statement: ‘IMPORTANT! KEEP FOR FUTURE REFERENCE.’, |
|
— |
instructions for correct and safe assembly and use of the chair-mounted seat, |
|
— |
information on the types of adult chairs to which the chair-mounted seat can and cannot be attached. |
The warnings in the user manual must be labelled ‘WARNING!’ and must convey at least the following messages or equivalent messages:
|
— |
‘Never leave the child unattended.’ |
|
— |
‘Always use the child restraint and chair attachment systems.’ |
|
— |
‘Ensure the chair attachment system is correctly fitted and adjusted before use.’ |
|
— |
‘Always check the security and the stability of the chair-mounted seat before use.’ |
The user manual must also provide the following information:
|
— |
the following statement or an equivalent statement: ‘This product is intended for children up to 36 months old, weighing a maximum of 15 kg, who are able to sit up unaided.’, |
|
— |
the adequate dimensions of the adult chair, seat and backrest, |
|
— |
a statement that the chair-mounted seat should not be used if any part is broken, torn or missing, |
|
— |
a statement that accessories or replacement parts other than those approved by the manufacturer must not be used, |
|
— |
cleaning and maintenance recommendations. |
2. CHILDREN’S CHAIRS
2.1. Scope
These safety requirements apply to children’s chairs intended for children who are able to sit up unaided. These include stools, chairs (assembly parts include: legs, seat base and backrest) and armchairs (assembly parts include: seat base, backrest and armrests) for indoor and outdoor use. Rocking chairs and foldable chairs are also included. The requirements also apply to multifunctional products that can be converted into children’s chairs. They also apply to children’s chairs fitted with wheels. Products that combine the function of a children’s chair with another function (for example, storage) must also comply with the requirements.
2.2. Safety requirements
Entrapment hazards from gaps and openings
Children’s chairs must be designed and manufactured to prevent the entrapment of limbs, feet and hands and as far as possible the entrapment of fingers in gaps and openings.
Foldable children’s chairs must be designed and manufactured to prevent the entrapment of fingers.
Children’s chairs must not be so heavy that a child’s head or limb can be entrapped under them.
Hazards associated with moving parts
Once the children’s chair is set up for normal use according to the manufacturer’s instructions, there must not be any hazardous moving parts.
Castors and wheels
Children’s chairs that are fitted with wheels or castors must be designed so as not to impair their stability.
Falling hazards
Children’s chairs must be stable enough to prevent overturning in all directions while the child is in them.
Stability
Children’s chairs must be stable.
Choking hazards
To prevent choking hazards, children’s chairs must not contain small parts that can be detached by forces that a child can apply and can fit entirely in a child’s mouth. Stuffing materials that constitute choking hazards must not become accessible when submitted to the forces that a child can apply. They must not constitute an additional choking hazard due to the size of the elements they contain or because these elements become sufficiently small or accessible when submitted to the forces that a child can apply.
Suffocation hazards
Children’s chairs must not have any plastic decals that are detachable by forces that a child can apply. They must not have any impermeable sheeting that could cover both the mouth and the nose and thus constitute suffocation hazards.
Ingestion hazards
To avoid the hazard of ingestion, children’s chairs must not contain separate or small parts that are detachable by forces that a child can apply and can pass through the child’s oesophagus. In any case, toxic materials or surfacing must not be used.
Surfaces
All surfaces must, to the extent compatible with the functions of the children’s chair, be smooth enough to prevent abrasions, cuts, scratches, grazes, burns or other injuries which might be caused incidentally while the chair is in use or by a child’s behaviour.
Hazardous edges
Children’s chairs must not have sharp edges or points. Accessible edges and corners must be rounded or chamfered. They must not have any pointed or protruding surface that constitutes a puncture hazard.
Structural integrity
Children’s chairs and their components such as the seat base, backrest and legs, must be able to withstand mechanical stress to which they are subjected during reasonable foreseeable use.
2.3. Safety information
Warnings and instructions for use must indicate to the parents or carers that children’s chairs located under a window could be used as a step by the child and cause the child to fall out of the window.
Safety information must be given in writing in the language(s) of the country in which the children’s chair is offered for retail sale and in self-explanatory pictograms. All markings must remain legible and any label used for the markings must not come off easily.
3. CHILDREN’S HIGH CHAIRS
3.1. Scope
These safety requirements apply to high chairs intended for children who are able to sit up unaided, from approximately six months to 36 months of age, weighing a maximum of 15 kg. If the children’s high chairs are designed to be converted into children’s chairs, they must also comply with the safety requirements that apply to children’s chairs.
If parts of the high chair are designed to be removable (e.g. a tray or a footrest), these safety requirements apply to the high chair with and without these part(s).
Products with a significant play value must also comply with the requirements of Directive 2009/48/EC of the European Parliament and of the Council (5) on the safety of toys (for example, a high chair that can be converted into a rocking horse).
3.2. Safety requirements
General
Connecting screws for direct fastening (e.g. self-tapping screws) must not be used for the assembly of any component that is designed to be removed or loosened when dismantling the high chair to transport or store it.
Exposed edges and protruding parts must be rounded or chamfered and they must not contain burrs or sharp edges.
Falling hazards
To avoid injuries due to the child’s standing up and falling or slipping out of the high chair, it must be designed in such a way that its restraint system prevents the child from standing up and falling or slipping out of it.
The high chair must be fitted with a restraint system that can be adjusted to the size of the child and must consist of at least a waist and crotch restraint. It must not be possible to use the restraint system without using the crotch restraint.
The restraint system, straps, anchoring points and fastening system must not break, become loose or tear away from their support under the internal and external forces that a child can apply.
The design of the restraint system must take into account all of a child’s potential movements in the high chair.
The height of the backrest of the high chair must be appropriately high. It must also be fitted with side armrests that are high enough to ensure that a child remains in the chair when he or she leans in any direction.
To avoid injuries due to the child’s pushing and/or pressing his or her feet against the dining table and forcing the high chair to fall backwards, it must be designed in such a way that its stability precludes a falling hazard.
Entanglement hazards
There must be no cords, ribbons or similar parts (with the exception of the restraint system) on high chairs that constitute entanglement hazards.
Entrapment hazards from gaps and openings
Children’s high chairs must be designed and manufactured to prevent the entrapment of any part of a child’s body.
Hazards associated with moving parts
To avoid the risk of shearing and crushing, shear and compression points must be avoided. If shear and compression points cannot be avoided for functional reasons, appropriate measures should be taken to ensure that they are safe.
Any part of the high chair that can fold or be detached must be locked so that a child using the product or another child cannot release it or an adult cannot inadvertently release it.
Locking mechanisms for folding high chairs
Locking mechanisms are required to prevent a high chair from folding while a child is in it and also when a child is being put in and taken out of it.
To avoid hazards arising from incorrect use of the high chair, either the weight of the child using the high chair must prevent it from folding or at least one locking mechanism must engage automatically when the high chair is being used.
Children must not be able to unintentionally release or operate the locking mechanisms.
Any locking mechanisms must continue to function properly when subjected to static and dynamic mechanical stress during reasonable foreseeable use of the high chair.
Choking hazards
No part that can be detached by the force that a child can apply must be small enough to fit entirely in a child’s mouth. Any component that can be removed without the use of a tool must not fit entirely in a child’s mouth. Stuffing materials that constitute choking hazards must not become accessible when submitted to the forces that a child can apply. Furthermore, they must not constitute an additional choking hazard due to the size of the elements they contain or because these elements become sufficiently small or accessible when submitted to the forces that a child can apply.
Restraint system
The high chair must be designed to secure children in the sitting position and to prevent falls when they stand up and lose their balance, either by using a restraint system comprising a crotch restraint and a horizontal component or by means of an integral harness. If the high chair is fitted with a reclinable backrest, it must have an integral harness.
Static and dynamic mechanical stress during reasonable foreseeable use of the high chair must not cause permanent damage, which can impair their safety and normal function, to crotch restraints, waist belts and straps of the integral harness.
When a high chair is fitted with a harness or belt attachment points, static and dynamic mechanical stress during reasonable foreseeable use of the high chair must not cause permanent damage to them which can impair their safety and normal function.
If an integral harness or a belt is supplied, it must be adjustable and static and dynamic mechanical stress during reasonable foreseeable use of the high chair must not cause permanent damage to it which can impair its safety and normal function.
Lateral protection
The high chair must be fitted with side armrests or other means of lateral protection.
Backrest
The high chair must be fitted with a backrest high enough to ensure that a child remains in the high chair when he or she leans in any direction.
Reclinable backrest
The mechanism that allows the backrest of the high chair to be adjusted must not slip from one position to another when subjected to static and dynamic mechanical stress during reasonable foreseeable use of the high chair.
Castors and wheels
High chairs that are fitted with wheels or castors must be designed so as not to impair their stability.
Structural integrity
The functions of the high chair must be unimpaired when it is subjected to static and dynamic mechanical stress during reasonable foreseeable use of the high chair.
The high chair must not collapse and the locking mechanism must remain engaged when subjected to static and dynamic mechanical stress during reasonable foreseeable use of the high chair.
Stability
If parts of the high chair are designed to be removable (e.g. a tray or a footrest), the stability requirement applies to the high chair with and without these part(s).
When the high chair is subjected to static and dynamic mechanical stress during reasonable foreseeable use, it must not overturn on its side, back or front.
3.3. Safety information, user manual and markings
General
The safety information must be given in writing in the language(s) of the country in which the high chair is offered for retail sale and in self-explanatory pictograms. All markings must remain legible and any label used for the markings must not come off easily during reasonable foreseeable use.
Safety information
Safety information must be provided, in a clear and conspicuous way. It must be labelled ‘WARNING!’ and must convey at least the following messages or equivalent messages:
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— |
‘Never leave the child unattended.’ |
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— |
‘Always use the restraint system.’ |
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— |
‘Always check the security and the stability of the high chair before use.’ |
Purchase information
The consumer must be able to clearly see the purchase information at the point of sale. The information must contain at least the following statement or an equivalent statement, both in writing and in a self-explanatory pictogram: ‘This product is intended for children up to 36 months old, weighing a maximum of 15 kg, who are able to sit up unaided.’ Additional safety information must be provided if the product can be altered, either to be used for play or to be converted into a children’s chair, that can be adjusted to fit the child at different stages of development (the ‘grow with the child’ feature).
Markings
High chairs must be permanently marked with the following warning or an equivalent warning: ‘WARNING! DO NOT LEAVE THE CHILD UNATTENDED.’ An appropriate pictogram must be used in conjunction with the warning.
User manual
In the user manual, instructions for use of the high chair must be provided and labelled with the statement ‘IMPORTANT! KEEP FOR FUTURE REFERENCE’ or an equivalent statement.
The instructions must contain the following warnings or equivalent warnings labelled ‘WARNING!’:
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— |
‘Do not leave the child unattended.’ |
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— |
‘Do not use the high chair unless all components are correctly fitted and adjusted.’ |
The user manual must also contain the following warnings:
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— |
make sure that any harness is correctly fitted, |
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— |
be aware of the risk of an open fire or other sources of strong heat, such as electric bar fires, gas fires, etc. in the vicinity of the high chair. |
The following safety information must be provided in the user manual:
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— |
an assembly drawing, a list and/or description of all parts and tools required to assemble the chair and a diagram of the bolts and other locking mechanisms, |
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— |
a statement that the high chair should not be used until the child can sit up unaided, |
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— |
a statement that the high chair should not be used if any part is broken, torn or missing, |
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— |
cleaning and maintenance recommendations. |
4. TABLE-MOUNTED CHAIRS
4.1. Scope
These safety requirements apply to table-mounted chairs, intended for children who are able to sit up unaided (from six months old) and who weigh up to 15 kg.
4.2. Safety requirements
General
The table-mounted chair, when assembled for use, must be assembled so as to prevent any risk of pinching, cutting or wounding for both the child and the carer.
Entrapment hazards from gaps and openings
To avoid entrapment, table-mounted chairs must not incorporate open-ended tubes, or have gaps or openings that could cause injuries to a child.
The design of table-mounted chairs must prevent the child from falling down through the gaps and openings.
Hazardous edges, corners and protruding parts
All accessible edges, corners and protruding parts of the table-mounted chair must be rounded and chamfered and must not contain burrs or sharp edges.
Choking hazards
To prevent choking hazards, chairs must not contain any small parts, whether intended to be removed without the use of a tool or not, that could be detached by forces that a child can apply and are small enough to fit entirely in a child’s mouth.
Stuffing materials that constitute choking hazards must not become accessible when submitted to the forces that a child can apply. Furthermore, they must not constitute an additional choking hazard due to the size of the elements they contain or because these elements become sufficiently small or accessible when submitted to the forces that a child can apply.
Ingestion hazards
To avoid ingestion hazards arising from incorrect use of the table-mounted chair, it must not contain separate or small parts that are detachable by forces that a child can apply and can pass through the child’s oesophagus.
Suffocation hazards
Chairs must not have any plastic decals that could be gripped by a child and detached by forces that a child can apply. They must not have any impermeable sheeting that could cover both the mouth and the nose of the child and thus constitute suffocation hazards.
Self-tapping screws
Connecting screws (e.g. self-tapping screws) must not be used to fasten any component that is designed to be removed or loosened when dismantling the table-mounted chair to transport or store it.
Hazards associated with moving parts
Once the table-mounted chair is set up for normal use according to the manufacturer’s instructions, there must not be any hazardous moving parts.
Falling hazards
To avoid injuries due to the child’s standing up and falling or slipping out of the table-mounted chair, it must be designed in such a way that its restraint system prevents the child from standing up and falling or slipping out of it.
The table-mounted chair must be fitted with a restraint system that can be adjusted to the size of the child and must consist of at least a waist and crotch restraint. It must not be possible to use the restraint system without using the crotch restraint.
The restraint system, straps, anchoring points and fastening system must not break, become loose or tear away from their support under the internal and external forces that a child can apply.
The design of the restraint system must take into account all of a child’s potential movements in the table-mounted chair.
When set up for use, the height of the backrest of the table-mounted chair must be appropriately high. It must also be fitted with side armrests that are high enough to ensure that a child remains in the chair when he or she leans in any direction.
Footrests
Footrests must not be provided.
Removable seats
If the seat can be removed from the frame, the fastening devices to anchor the seat to the frame must be designed so as to prevent the seat from being inadvertently detached from the frame.
The seat must remain attached to the frame when subjected to mechanical stress during reasonable foreseeable use of the table-mounted chair.
Structural integrity
Static and dynamic mechanical stress during reasonable foreseeable use of the table-mounted chair must not cause permanent damage, which can impair its safety and normal function, to the table-mounted chair.
Anchoring support
Anchoring support must ensure that when attached to the support surface, the table-mounted chair is not moved during reasonable foreseeable use. Anchoring of the table-mounted chair must be resistant to bouncing.
Stability
Table-mounted chairs must not fold or overturn when static and dynamic mechanical stress to which they are subjected during reasonable foreseeable use is applied.
4.3. Safety information, user manual and markings
General
Safety information must be marked on the product and included in the instructions to the user.
Safety information must be given in writing in the language(s) of the country in which the table-mounted chair is offered for retail sale and in self-explanatory pictograms. All markings must remain legible and any label used for the markings must not come off easily.
Purchase information
The consumer must be able to clearly see the purchase information at the point of sale. The information must contain at least the following, both in writing and in a self-explanatory pictogram:
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— |
this statement or an equivalent statement: ‘This product is intended for children who weigh a maximum of 15 kg and can sit up unaided.’, |
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the adequate dimensions of the supporting surface to which the table-mounted chair can be attached. |
The following information must also be given:
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‘This table-mounted chair is not suitable for use with all tables. Do not use with glass-topped tables, tables with loose table tops, table leaves, single pedestal tables, card tables or camping tables.’ |
Markings
The table-mounted chair must be visibly and permanently marked as follows:
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the warning ‘WARNING! Never leave the child unattended’ must be visible when the table-mounted chair is being used, |
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the warning ‘WARNING! Always use the child restraint and table attachment systems.’, |
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the warning ‘WARNING! Always check the security and the stability of the table-mounted chair before use.’, |
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the statement ‘Maximum weight: 15 kg.’ |
User manual
Instructions concerning correct and safe assembly and use of the table-mounted chair must be provided in the user manual. These instructions must be precise and unambiguous and must include at least the following statements or equivalent statements:
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‘Read the instructions carefully before use and keep them for future reference. Your child may be hurt if you do not follow the instructions.’ |
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‘This table-mounted chair is not suitable for children who cannot sit up unaided.’ |
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‘WARNING! Never leave the child unattended.’ |
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‘Always use the child restraint and table attachment systems.’ |
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‘Always check the security and the stability of the table-mounted chair before use.’ |
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‘This table-mounted chair is not suitable for use with all tables. Do not use with glass-topped tables, tables with loose table tops, table leaves, single pedestal tables, card tables or camping tables.’ |
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‘Check that the table will not tip over when the table-mounted chair, attached to it, is in use.’ |
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‘Do not use tablecloths or other objects on the support surface that might interfere with the proper functioning of the anchoring elements. Keep the table structure and surface clean and dry.’ |
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‘This table-mounted chair must not be used by children who weigh more than 15 kg.’ |
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‘Routinely check any clamping screws and tighten them if necessary.’ |
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‘WARNING! Do not use the table-mounted chair if any components are broken or missing.’ |
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‘Do not use replacement parts other than those approved by the manufacturer or distributor.’ |
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‘Do not attach the table-mounted chair where the child might use its feet to push against a part of the table, another chair or any other structure as this could cause the table-mounted chair to come off the table.’ |
The adequate dimensions of the support surface must be specified.
(1) As defined in Article R1 of Chapter R1 of Annex I to Decision No 768/2008/EC of the European Parliament and of the Council (OJ L 218, 13.8.2008, p. 82).
(2) As specified in Article R2 of Chapter R2 of Annex I to Decision No 768/2008/EC.
(3) As defined in Article R1 of Chapter R1 of Annex I to Decision No 768/2008/EC.
(4) As specified in Article R4 of Chapter R2 of Annex I to Decision No 768/2008/EC.
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8.3.2013 |
EN |
Official Journal of the European Union |
L 65/35 |
COMMISSION IMPLEMENTING DECISION
of 7 March 2013
determining the date from which the Visa Information System (VIS) is to start operations in a fourth and a fifth region
(2013/122/EU)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 767/2008 of the European Parliament and of the Council of 9 July 2008 concerning the Visa Information System (VIS) and the exchange of data between Member States on short-stay visas (VIS Regulation) (1), and in particular Article 48(3) thereof,
Whereas:
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(1) |
According to Commission Implementing Decision 2012/274/EU of 24 April 2012 determining the second set of regions for the start of operations of the Visa Information System (VIS) (2), the fourth region where the collection and transmission of data to the VIS for all applications should start comprises Benin, Burkina Faso, Cape Verde, Côte d’Ivoire, the Gambia, Ghana, Guinea, Guinea-Bissau, Liberia, Mali, Niger, Nigeria, Senegal, Sierra Leone and Togo; and the fifth region comprises Burundi, Cameroon, Central African Republic, Chad, Congo, Democratic Republic of the Congo, Equatorial Guinea, Gabon, Rwanda and São Tomé and Principe. |
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(2) |
The Member States have notified the Commission that they have made the necessary technical and legal arrangements to collect and transmit the data referred to in Article 5(1) of the VIS Regulation to the VIS for all applications in those two regions, including arrangements for the collection and/or transmission of the data on behalf of another Member State. |
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(3) |
The condition laid down by the first sentence of Article 48(3) of the VIS Regulation thus being fulfilled, it is therefore necessary to determine the date from which the VIS is to start operations in a fourth and a fifth region. |
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(4) |
In view of the need to set the date for the start of the VIS in the very near future this Decision should enter into force on the day of its publication in the Official Journal of the European Union. |
|
(5) |
Given that the VIS Regulation builds upon the Schengen acquis, Denmark notified the implementation of the VIS Regulation in its national law in accordance with Article 5 of the Protocol on the position of Denmark annexed to the Treaty on European Union and to the Treaty establishing the European Community. Denmark is therefore bound under international law to implement this Decision. |
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(6) |
This Decision constitutes a development of provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengen acquis (3). The United Kingdom is therefore not bound by it or subject to its application. |
|
(7) |
This Decision constitutes a development of provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC of 28 February 2002 concerning Ireland’s request to take part in some of the provisions of the Schengen acquis (4). Ireland is therefore not bound by it or subject to its application. |
|
(8) |
As regards Iceland and Norway, this Decision constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement concluded by the Council of the European Union and the Republic of Iceland and the Kingdom of Norway concerning the latters’ association with the implementation, application and development of the Schengen acquis (5), which fall within the area referred to in Article 1, point B of Council Decision 1999/437/EC (6) on certain arrangements for the application of that Agreement. |
|
(9) |
As regards Switzerland, this Decision constitutes a development of the provisions of the Schengen acquis within the meaning of the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis (7), which fall within the area referred to in Article 1, point B of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2008/146/EC (8). |
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(10) |
As regards Liechtenstein, this Decision constitutes a development of the provisions of the Schengen acquis within the meaning of the Protocol between the European Union, the European Community, the Swiss Confederation and the Principality of Liechtenstein on the accession of the Principality of Liechtenstein to the Agreement between the European Union, the European Community and the Swiss Confederation on the Swiss Confederation’s association with the implementation, application and development of the Schengen acquis (9), which fall within the area referred to in Article 1, point B of Decision 1999/437/EC read in conjunction with Article 3 of Council Decision 2011/350/EU (10). |
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(11) |
As regards Cyprus, this Decision constitutes an act building upon, or otherwise related to, the Schengen acquis within the meaning of Article 3(2) of the 2003 Act of Accession. |
|
(12) |
As regards Bulgaria and Romania, this Decision constitutes an act building upon, or otherwise related to, the Schengen acquis within the meaning of Article 4(2) of the 2005 Act of Accession, |
HAS ADOPTED THIS DECISION:
Article 1
The Visa Information System shall start operations in the fourth and in the fifth region determined by Implementing Decision 2012/274/EU on 14 March 2013.
Article 2
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.
Article 3
This Decision shall apply in accordance with the Treaties.
Done at Brussels, 7 March 2013.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 218, 13.8.2008, p. 60.
(2) OJ L 134, 24.5.2012, p. 20.
(3) OJ L 131, 1.6.2000, p. 43.
(5) OJ L 176, 10.7.1999, p. 36.
(6) OJ L 176, 10.7.1999, p. 31.
(7) OJ L 53, 27.2.2008, p. 52.
