Italy, as part of the EC, implemented a complete legal framework on
GMOs, which also addresses issues of handling, transport, packaging
and identification referred to Article 18. The following acts
of direct relevance to the implementation of Article 18:
Article 18 (1):
- Council Directive 94/55 of 21 November 1994 on
approximation of the laws of members States with regard to the
trasport of dangerous goods by road (last emended by
Commission Diretive 2006/89/EC implement with Ministerial Decree 3
Jannuary 2007
- Council Directive 96/49 of 23 July 1996 on
approximation of the laws of the MS with regard to transport of
dangerous good by rail (las emended by Commission Directive
2004/89/EC, implement with Ministeril Decree 7 November
2006)
Article 18 (2) a:
- Article 12 of Regulation (EC) 1946/2003 of 15 July
2003 on transbounderay movments of GMOs;
- Regulation (EC) 1829/2003 of 22 september 2003 on GMO food and
feed
- Regulation (EC) 1830/2003 of 22 September 2003 concerning the
traceability and labelling of GMO and traceability of products
-produced from GM
Italy, as part of the EC, support in the approval process for GMOs
requires validation of an event-specific detection method for the
relevant GMO (see in particular regulation (EC) No 1829/2003).
Italy contributes to the validation of GMO detection methods
with n.3 National Reference Centre (ISS, IZS and INRAN)
carried out by the European Union Reference Laboratory for GM Food
Feed (EU-RL GMFF see
http://gmo-crl.jrc.ec.europa.eu/)
- that it contains or consists of GMOs; and
- the unique identification code(s) assigned to those GMOs if such
codes exist.
Article 12 of Regulament 1946/2003 further stipulates that
for GMOs intended for direct use as food or feed, or for
processing, the above information must be supplemented by a
declaration by the exporter:
- stating that the GMOs are intended for direct use as food or
feed, or for processing and indicating clearly that they are not
intended for deliberate release into the environment; and
- giving details of the contact point for further
information.
In the case of products consisting of or containing mixtures of
GMOs to be used only and directly as food or feed, or for
processing, the above identification requirements may be replaced
by a list of unique identifiers used to constitute the
mixture.
Regulation 1829/2003 lays down rules on labelling of all GM food
and feed. GM food and feed has to be labelled as GM, except if they
contain GM material in a proportion no higher than 0.9% and if this
presence is adventitious or technically unavoidable.
Under Regulation (EC) 1830/2003 of 22 September 2003 concerning the
traceability and labelling of genetically modified organisms and
the traceability of food and feed products produced from
genetically modified organisms, business operators must transmit
and retain information about products that contain or are produced
from GMOs at each stage of the placing on the market. In
particular, the Regulation requires that:
- operators are to have systems and standardised procedures in
place to identify to whom and from whom products are made
available;
- in the case of products consisting of or containing mixtures of
GMOs to be used only and directly as food or feed or for
processing, written information on the unique identifier(s)
assigned to the GMOs of which the product consists or which are
contained in it, may be replaced by a declaration of use by the
operator, accompanied by a list of the unique identifiers for all
those GMOs that have been used to constitute the mixture.
In Regulation (EC) No 65/2004 of 14 January 2004, the EC has
established a system for the development and assignment of unique
identifiers for genetically modified organisms. The Regulation
adopts the format developed by the OECD for Unique Identifiers for
Transgenic Plants, which in mid-April 2004 became mandatory for the
EC's domestic regulatory framework for GMOs. Moreover, the EC has
extended use of this format to unique identifiers for genetically
modified micro-organisms and animals pending the development and
adoption of any other specific format at an international level.
The EC considers the use of the unique identifier as a key to
access information available on the Biosafety Clearing-House.
In relation to Article 18(2)(b), the EC wishes to recall that EC
legislation contains rules on identification of GMOs that are
destined for contained use, in line with the Protocol. Regulation
No (EC) 1946/2003 on transboundary movements of genetically
modified organisms requires exporters of GMOs destined for
contained use to state in accompanying documentation
- that it contains or consists of GMOs;
the unique identification code(s) assigned to those GMOs if such
codes exist;
In addition, this information shall be supplemented by a
declaration by the exporter which shall specify:
- any requirements for the safe handling, storage, transport and
use of the GMOs; and
- the contact point for further information, including the name and
address of the individual or institution to whom or which the GMOs
are consigned.
In relation to Article 18(2)(c), Regulation No (EC) 1946/2003
requires exporters of GMOs destined for deliberate release into the
environment to ensure that documentation accompanying the GMO
states:
- that it contains or consists of GMOs; and
- the unique identification code(s) assigned to those GMOs if such
codes exist;
In addition, this information shall be supplemented by a
declaration by the exporter which shall specify:
- the identity and relevant traits and characteristics of the
GMOs;
- any requirements for the safe handling, storage, transport and
use of these GMOs;
- the contact points for further information and, as appropriate,
the name and address of the importer and exporter; and
- a declaration that the movement is in conformity with the
requirements of the Protocol applicable to the exporter.
In this contest legilslative decree 223/2003, implementing
Directives n. 2000/77/EC and 2001/46/EC required advance contact
operator with transboundari moviment points.
The above requirements regarding identification and documentation
of GMOs are in line with Article 18 of the Protocol and without
prejudice to further specific requirements imposed by EC
legislation.