MINISTRY OF HEALTH

DECREE 4 November 2019 

Definition of maximum levels of tetrahydrocannabinol (THC) in food.(20A00016)

(OJ General Series n.11 of 15-01-2020

Source: https://www.gazzettaufficiale.it/eli/id/2020/01/15/20A00016/sg

         THE MINISTER OF HEALTH 
 
  Given the law of 2 December 2016, n. 242, bearing: «Provisions for
the promotion of cultivation and the agro-industrial chain
hemp ", published in the Official Gazette of the Republic
Italian December 30, 2016, n. 304, and in particular art. 5;
  Given the law of 24 December 2012, no. 234, bearing: «General rules
on Italy's participation in training and implementation
European Union legislation and policies "; 
  Having regard to Regulation (EEC) no. 315/1993 of the Council of 8
February 1993, which establishes Community procedures relating to
contaminants in food; 
  Having regard to Regulation (EC) no. 178/2002 of the European Parliament and of
Council of 28 January 2002, which establishes the principles and
general requirements of food law establishes
the European Food Safety Authority and establishes procedures in the
food safety; 
  Having regard to Regulation (EC) no. 852/2004 of the European Parliament and of
Council of 29 April 2004 on the hygiene of food products; 
  Having regard to Regulation (EC) no. 853/2004 of the European Parliament and of
Council of 29 April 2004 laying down specific rules in
hygiene matters for food of animal origin; 
  Having regard to Regulation (EC) no. 854/2004 of the European Parliament and of the
Council of 29 April 2004 laying down specific rules for
the organization of official controls on products of origin
animal intended for human consumption; 
  Having regard to Regulation (EC) no. 882/2004 of the European Parliament and of
Council of 29 April 2004 on official controls aimed at
check compliance with feed and food regulations
food and animal health and welfare regulations, e
further modifications; 
  Having regard to the «Guidelines for official control pursuant to
regulations (EC) no. 882/2004 and 854/2004 "(Understanding between the Government,
regions and autonomous provinces of Trento and Bolzano on 10 November
2016); 
  Having regard to Regulation (EC) no. 1881/2006 of the Commission dated 19
December 2006 which defines the maximum levels of some contaminants
in food; 
  Having regard to Regulation (EU) no. 68/2013 of the Commission on the catalog
feed materials; 
  Having regard to Regulation (EU) no. 1306/2013 of the European Parliament and of
Council of 17 December 2013 on financing, management and
on monitoring the common agricultural policy and repealing i
Council regulations (EEC) no. 352/1978, (CE) n. 165/1994, (CE)
n. 2799/1998, (CE) n. 814/2000, (CE) n. 1290/2005 and (CE) n. 485/2008;
  Having regard to Regulation (EU) no. 1307/2013 of the European Parliament and of
Council of 17 December 2013 laying down rules on direct payments
to farmers under the support schemes provided for in
common agricultural policy and repealing regulation (EC) no. 637/2008
of the Council and Regulation (EC) no. 73/2009 of the Council and in
especially the art. 32, paragraph 6;
  Given the delegated regulation (EU) no. 639/2014 of the Commission
of 11 March 2014 which integrates regulation (EU) no. 1307/2013 of
European Parliament and Council laying down rules on payments
addressed to farmers under the envisaged support schemes
from the common agricultural policy and amending Annex X to it
regulation, as amended by delegated regulation (EU) no.
1155/2017 of the Commission; 
  Having regard to Regulation (EU) no. 2015/2283 of the European Parliament and of the
Council of 25 November 2015 relating to novel foods and which
amends regulation (EU) no. 1169/2011 of the European Parliament e
of the Council and repeals Regulation (EC) no. 258/97 of the Parliament
European Council and Council Regulation (EC) no. 1852/2001 of the
Commission; 
  Having regard to Recommendation (EU) no. 2016/2115 of the Commission of the 1st
December 2016 on monitoring the presence of Δ 9
-tetrahydrocannabinol, its precursors and other derivatives of
cannabis in food; 
  Having regard to the decree of the President of the Republic July 14, 1995,
bearing: «Act of direction and coordination to the regions and provinces
autonomous on the uniform criteria for the elaboration of the
official control of food and drink '; 
  Having regard to the circular note of the Directorate-General for Security
Ministry of Food and Nutrition of 22 May 2009
labor, health and social policies on production e
marketing of hemp seed products for
use in the areas of human nutrition; 
  Having regard to the opinion of EFSA (European Safety Authority
food): «Scientific Opinion on the safety of hemp (Cannabis
genus) for use as animal feed "(EFSA Journal 2011; 9 (3): 2011); 
  Having regard to EFSA's opinion: «Scientific Opinion on the risks for
human health related to the presence of tetrahydrocannabinol (THC) in
milk and other food of animal origin "(EFSA Journal 2015; 13 (6): 4141); 
  Considering that art. 2 of Regulation (EC) no. 178/2002 no
it includes narcotic or psychotropic substances among foods
under the United Nations Single Convention on Narcotic Drugs
of 1961 and the United Nations Convention on Substances
psychotropic of 1971; 
  Considered that hemp grown exclusively for the
production of fibers or for other industrial uses permitted by
European Union legislation, other than those referred to in art. 27
of the decree of the President of the Republic 9 October 1990, n. 309,
containing: «Consolidated text of the laws governing
drugs and psychotropic substances, prevention, treatment and
rehabilitation of the related states of drug addiction ", is not
subject to the discipline of art. 26 of the aforementioned decree of the
President of the Republic n. 309/1990;
  Considering that art. 32, paragraph 6, of Regulation (EU) no.
1307/2013 allows the cultivation in the European Union of varieties
of Cannabis sativa L. as long as they are present in the common catalog of
variety of plant species with a THC content not higher
0.2%; 
  Considered that hemp seeds and hemp seed derivatives for use
food have recorded a significant history of consumption
as food before 1997 and, therefore, are not to be considered
novel food pursuant to the aforementioned regulation (EU) no. 2015/2283;
  Considering that cannabinoids are not currently included
among the undesirable substances in foods referred to in the regulation
(CE) n. 1881/2006 of the Commission and subsequent amendments, and that
Article. 5 of Regulation (EEC) no. 315/1993 of the Council allows
Member States to adopt maximum limits for specific
contaminants in food if they have not been adopted
Community provisions; 
  Considered, for the precautionary principle, the opportunity of
analytically determine the sum of the substance Δ 9   -THC and of the
inactive acid precursor Δ 9 -THCA-A which can give rise to
substance Δ 9 -THC following thermal processes;
  It was deemed necessary to implement art. 5 of law 2
December 2016, n. 242;
  Given the decree of the general manager for hygiene and safety
of food and nutrition 16 March 2017 of establishment, at
the Ministry of Health, of the «working group for the objectives of
referred to in art. 5 of the law 2 December 2016, n. 242 ';
  Having obtained the opinion of the Higher Institute of Health, rendered with
note prot. 20675 of 18 May 2017, on the maximum limits of THC in the
foods as a measure for risk management
exposure; 
  Obtained the opinion of the aforementioned working group through
electronic consultation; 
  Having heard the opinion of the Superior Health Council, expressed
in the session of 9 October 2018; 
  Having regard to the procedure pursuant to art. 5 of Regulation (EEC) no.
315/1993 which establishes community procedures relating to
contaminants in food; 
  Having regard to the communication to the Commission of the European Union
carried out on 12 October 2018 pursuant to directive (EU) no.
2015/1535; 
 
                              decrees: 
 
                               Art. 1 
 
                        Field of application 
 
  1. This decree establishes the values ​​of the maximum concentrations
(maximum limits) of total THC admissible in food for the purposes of
official control.