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THE MINISTERS Powered By Docstoc
					                                                                 Athens / / 2011
                                                                 Ref. No. Z3-192
MINISTRY OF LABOUR & SOCIAL SECURITY
GENERAL SECRETARIAT FOR CONSUMER AFFAIRS
                                                                  DECISION
Postal address: Kaningos Square
Post code: Athens GR-10181
Information: K. Zisis
Telephone: 210-3893327
FAX            : 210-3847676
Εmail:         : zisis@efpolis.gr


   1. ------IND- 2011 0125 GR- EN- ------ 20110329 --- --- PROJET

   SUBJECT:                Decision to ban the placement on the market of
   ‘compressed tissue’ products of a swallowable shape and size, which are
   not suitably marked and which do not bear suitable warnings about the
   potential risks to the health and safety of children

                                 THE MINISTERS
        OF THE INTERIOR, DECENTRALISATION & E-GOVERNMENT, JUSTICE,
              TRANSPARENCY & HUMAN RIGHTS, AND LABOUR & SOCIAL
                                   SECURITY

   Having regard to:

   1.    The provisions of Article 14(4) of Law 2251/1994 on consumer protection, as
         amended by Article 16(2) of Law 3853/2010 (Government Gazette
         90/A/17.6.2010) as in force from time to time.
   2.    Article 90 of the Government and Governmental Agencies Code ratified by
         Article I of Presidential Decree 63/2005 on codification of the legislation on
         government and governmental agencies (Government Gazette 98/A/2005).
   3.    Presidential Decree 197/1997 on the establishment of the General Secretariat
         for Consumer Affairs and designation of its duties (Government Gazette
         156/A/30.7.1997).
   4.    Presidential Decree 185/2009 on the re-establishment of the Ministry of
         Finance, merger of the Ministries of Economy & Finance with the Ministries of
         Development and Mercantile Marine, the Aegean & Island Policy, and
         renaming thereof, the Ministry of Economy, Competitiveness & Shipping,
         conversion of the Ministry of Macedonia-Thrace into a General Secretariat for
         Macedonia – Thrace and inclusion of the General Secretariat for Macedonia –
         Thrace and the General Secretariat for the Aegean and Island Policy within
         the Ministry of the Interior (Government Gazette 213/A/7.10.2009).
   5.    Presidential Decree 89/2010 (Government Gazette 154/A/7.9.2010) on the
         appointment of ministers, deputy ministers and assistant ministers.
   6.    Presidential Decree 96/2010 (Government Gazette 170/A/28.9.2010) on the
         establishment of the Ministry of Marine Affairs, Islands & Fisheries,
         designation of its competences and reallocation of the competences of
         Ministries.
   7.    Joint Decision No. 20854/54/20.10.2010 of the Prime Minister and Minister of
         Labour & Social Security on designation of the competences of the Deputy
         Ministers of Labour & Social Security, Vasilios Kengeroglou and Anna Dalara
         (Government Gazette 1673/B/21.10.2010).
8.    Article 9 (Staffing and Organisation of the General Secretariat for Consumer
      Affairs) of Law 3892/2010 on electronic registration and filling of doctor‟s
      prescriptions and referrals for medical examinations (Government Gazette
      189/A/4.11.2010).
9.    The provisions of Law 2251/1994 on consumer protection as amended and
      supplemented by the provisions of Law 3587/2007 (Government Gazette
      152/A/10.7.2007) and Joint Ministerial Decision No. Z3-2810/2004 on
      general product safety.
10.   The provisions of Joint Ministerial Decision No. Φ3-3193/8.8.1989 on
      products which are not presented in their actual form, thereby placing the
      health or safety of consumers at risk (Government Gazette 609/B/21-8-89).
11.   The ELOT ΕΝ-71.1:2006 standard “Game / Toy Safety: mechanical and
      physical properties”.
12.   The provisions of Article 39 of codified market police decree No. 7/2009
      (Government Gazette 1388/B/2009) as in force from time to time.
13.   The complaint made on 21 May 2010 to the General Secretariat for Consumer
      Affairs that a product in the form of a compressed tissue, in a shape and
      format similar to a sweet, was found to be in circulation in the possession of
      primary school pupils in the Evosmos area, which could entail a potential risk
      of choking if a small child put it in its mouth.
14.   The fact that minimum exposure of young children to the product must be
      ensured, since it could potentially entail a risk to their health.
15.   The provisions of Presidential Decree 39/2001 establishing an information
      procedure in the field of technical standards, norms and rules relating to
      Information Society services in compliance with Directives 98/34/EC and
      98/48/EC (Government Gazette 28/A/28.2.2001).
16.   The fact that the provisions of this decision do not incur any expense to the
      State budget.


                                WE HEREBY DECIDE
                                     Article 1
                                      Definitions
For the purposes of this Decision, the following definitions shall apply:


    (1) “Product”: compressed tissue, of swallowable shape and size which
resembles a sweet, lozenge or pill, which expands in size when it comes into
contact with liquid.
    (2) “Swallowable shape and size”: a shape and size which fits completely into
the cylinder for small parts which is defined in Standard EN-71:1:2005.
    (3) “Outer packaging”: a container which includes one or more items of the
product, packaged or not.
    (4) “Inner packaging”: the individual packaging surrounding each item of the
product.
    (5) “Availability on the market”: Any supply of products on the Greek market
for distribution, consumption or use in the context of a commercial activity for a
fee or gratis;
    (6) “Placing on the market”: The first time at which a product is placed on the
Greek market.
    (7) “Withdrawal”: any measure which seeks to prevent the distribution,
display for sale or supply of the product.
    (8) The “competent authorities” for implementing this decision are the
Technical Inspection Directorate of the General Secretariat for Consumer Affairs /
Ministry of Labour & Social Security, and the local regional trade directorates
responsible for market surveillance




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    (9) “Person responsible for placing the item on the market”: the person who,
in his capacity as manufacturer or distributor, within the meaning of Article 2(e)
and (f) respectively of Joint Ministerial Decision No. Z3-2810/14.12.2004
(Government Gazette 1885/B/2004), places the product on the Greek market for
the first time for the purpose of distribution, consumption or use.


                                    Article 2
                                      Ban

1. Products which do not bear the suitable warnings or indications required by
Article 3(1) of this Decision shall be banned from being placed on the Greek
market or being available on the Greek market.
2. Any stocks which do not meet the requirements of Article 3(1) of this Decision
shall be withdrawn from the Greek market by their holders from the date on
which this Decision is published.
3. The sale of the product (in any packaging, on its own or in multi-packs) to
children aged under 14 is banned.

                                     Article 3
Obligations of the manufacturer / distributor of products in the form of packaged
                              compressed tissue

1. The persons responsible for placing the product on the market shall be obliged,
as a condition for placing the products on the Greek market, to ensure the
following so that they comply with the general safety requirements laid down in
Article 7(1) of Law 2251/1994 on consumer protection, as amended and in force:

       a) The product labelling (on both the outer and inner packaging) does not
       use terms or adjectives which refer to tricks / farces and make the product
       attractive to young children, such as the word magic for example.

      b) The product shall have clearly legible, indelible, boldly coloured
      characters on the outer packaging as follows:
      i) the phrase „compressed tissue‟ on the front, under the product‟s trade
      name
      ii) an enlarged warning which reads „ATTENTION! This product is not a toy.
      Do not swallow. Risk of Choking. NOT SUITABLE FOR CHILDREN AGED
      UNDER 14”, surrounding by a frame so that it is clearly visible to
      consumers.

      in addition to the usage instructions and precautions, as specified
      from time to time by the product manufacturer

      c) The product shall have clearly legible, indelible, boldly coloured
      characters on the inner packaging as follows:
      i) the phrase „compressed tissue‟ on the front, under the product‟s trade
      name
      ii) an enlarged warning which reads „ATTENTION! Do not swallow. Risk of
      Choking. NOT SUITABLE FOR CHILDREN AGED UNDER 14”, so that it is
      clearly visible to consumers.

      d) The warnings / indications must be printed in the Greek language as a
      minimum.

2.    Distributors are obliged, before placing a product on the market, to verify
that the products bear the warnings / indications required by paragraph 1 of this
Article in the Greek language at least.



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3. The persons responsible for placing the products on the market, in
collaboration with distributors in the supply chain, including retailers, shall ensure
that products which do not bear the necessary warnings / indications required by
paragraph 1 of this Article are withdrawn from the Greek market.
4. In order to meet their general obligation to place safe products on the
market, manufacturers and distributors are obliged as part of their activities, to
comply with the provisions of Article 5 of Joint Ministerial Decision No. Z3-
2810/14.12.2004 on general product safety – transposition of Council Directive
2001/95/EC of 21 December 2001 into national law (Government Gazette
1885/B/2004). In addition, in order to ensure implementation of the provisions of
Article 2(3) of this Decision, the persons responsible for placing the products on
the market, in collaboration with distributors in the supply chain, shall inform all
middlemen in the supply chain down to the level of retailers about the obligations
deriving from this provision. Copies of said written warning and the relevant proof
of its notification shall be kept on record and submitted by said persons to the
Technical Inspection Directorate of the General Secretariat for Consumer Affairs
where infringements are identified by the market surveillance authorities.


                                    Article 4
                  Obligations of the market surveillance authorities

1. The competent market surveillance authorities shall carry out suitable checks
at product points of sale to ascertain whether the products bear the warnings /
indications required by Article 3(1) of this Decision.
2. Products which do not bear the warnings / indications required by Article 3(1)
of this Decision shall be temporarily impounded by the competent authorities at
the premises of the persons holding them.
3. In this case the person responsibly for placing the products on the market shall
be called upon in writing by the Technical Inspection Directorate of the General
Secretariat for Consumer Affairs or the regional trade directorates to organise the
withdrawal within a reasonable time period. The results of said inspections
accompanied by copies of the purchase or import documentation shall be sent to
the Technical Inspection Directorate of the General Secretariat for Consumer
Affairs   in order to collect statistical data in the case where products not
conforming to the provisions of this Decision are found, and shall also be sent for
submission of a notice via the RAPEX (rapid exchange of information) system for
unsafe products, if necessary, and for the sanctions specified in Article 5 hereof to
be imposed.
4. Where the economic operators concerned do not respond or do not accept the
corrective measures recommended by the Technical Inspection Directorate or the
regional trade directorates, a ministerial decision shall be issued requiring the
appropriate measures to be taken and stating the fate of the specific products, in
accordance with Article 7(6) of Law 2251/1994 on consumer protection as
amended and supplemented by Law 3587/2007 (Government Gazette
152/B/10.7.2007). The economic operators concerned shall be given the
opportunity to state their views before the ministerial decision is issued. This
decision may be challenged by the parties concerned before the competent courts
and before the competent Minister by lodging an administrative appeal to him, in
accordance with the procedure provided for in Article 7(12) of Law 2251/1994 on
consumer protection, as amended and supplemented by Law 3587/2007
(Government Gazette 152/B/10.7.2007).

                                  Article 5
                                 Sanctions

The sanctions laid down in the provisions of Article 13a (Sanctions) of Law
2251/1994 on consumer protection, as amended and supplemented by Law



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3587/2007 (Government Gazette 152/B/10.7.2007), as currently in effect, shall
also apply to persons infringing the provisions hereof.

                                  Article 6
                            Final Provisions

This Decision shall take effect without prejudice to the provisions of Article 39(A)
of the codified market police decree No. 7/2009 (Government Gazette
1388/B/2009).

                              Article 7
                             Entry into force

1. This Decision shall enter into effect from its publication in the Government
Gazette.
2. This decision shall be published in the Government Gazette.



  MINISTER FOR THE INTERIOR,                   DEPUTY MINISTER FOR LABOUR &
    DECENTRALISATION & E-                            SOCIAL SECURITY
         GOVERNMENT
        G. RANGOUSIS                                 V. KENGEROGLOU

       MINISTER FOR JUSTICE, TRANSPARENCY & HUMAN RIGHTS
                          C. KASTANIDIS




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