Voluntary Report - public distribution

**Date:** 7/12/2004

**GAIN Report Number:** IT4012

IT4012

**Italy**

**Sanitary/Phytosanitary/Food Safety**

**FAQs about Pesticide MRLs**

**2004**

**Approved by:**

![](media/image1.wmf)Ann Murphy

U.S. Embassy

**Prepared by:**

Alberto Menghini

**Report Highlights:**

This report responds to a questionnaire circulated by FAS Horticultural
and Tropical Products Division in May 2004, and gives details on Maximum
Residues Llimits for pesticides in foodstuffs. It supplements EU
reporting (E23045).

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Rome \[IT1\]

\[IT\]

The following report is the reply from FAS Rome to a questionnaire
circulated by FAS Horticultural and Tropical Products Division in May
2004 about Maximum Residues Limits of pesticides in foodstuff.

*1. Which government agencies are involved in MRL establishment and what
are their responsibilities?*

A. Most MRLs are set at EU level. The Directorate General for public
veterinary, food and nutrition health of the Italian Ministero della
Salute (Ministry of Health) implements and integrates them at country
level.

MOH is also assisted by the national Istituto Superiore di Sanita'
(Superior Institute of Health) in a number of technical- scientific
tasks, including the revision of laboratory analysis.

Monitoring on imports is done through border inspection services and
their health units. They report to MOH.

Monitoring on national production and commerce is carried out by local
health units that are under the control of local city councils. They
report to MOH.

MOH also coordinates a unit of Carabinieri (military police) called
Nucleo Anti Sofisticazioni e Sanita' or N.A.S. (Anti-adulteration Unit).
They conduct police investigations on MRLs and other foodstuff offences
through their local sub-units.

*2. What laws and regulations guide the development and enforcement of
MRLs for pesticides?*

The reference law is the Decree of Minister of Health of May, 19 2000
(Decreto del Ministro della sanità del 19 maggio 2000), establishing
MRLs for foodstuff for human consumption. It implements EU Directives
97/41/CE and 1999/65/CE and 1999/71/CE. The Decree has been updated
fourteen times thereafter, the last one in February 19, 2004. It
includes MRLs that are set by implementation of EU Directives as well as
those that are set at country level.

A consolidated text of the Italian law with all the annexes and the
updates on MRLs is available (in Italian) at:
<http://www.ministerosalute.it/alimenti/sicurezza/sicApprofondimento.jsp?lang=italiano&label=pro&id=167>

Annex I is about products' classification, having regard of EU, Codex
and pre-existing national classification.

Annex II reports MRLs in foodstuff of non-animal origin for human
consumption. MRLs that are set at EU level are highlighted and therefore
clearly identifiable from those that are set at country level.

About 198 MRLs are already harmonized with the EU while 752 are not yet.

The same Decree of Minister of Health (of May, 19 2000) defines rules
for enforcement of MRLs and controls. Controls are carried on by local
health units and Carabinieri at distribution level or, in some cases, by
border inspection services. Ministry of agriculture may in some cases
monitor imports through the Ispettorato Centrale Repressione Frodi
(Central Inspectorate for Frauds Repression) in order to detect
commercial frauds and/or illegal imports of goods.

A new consolidated text on MRLs is expected in July 2004.

*3. What is the process for the establishment of MRLs?*

Those that are established at EU level by Directive 91/414/CEE and later
modifications. The Directive was adopted at country level with Decreto
Legislativo March 17, 1995 number 194 and updated thereafter.

Companies apply for authorization of products to MOH providing detailed
information on uses, toxicology, environmental impact, etc. MRLs are
proposed by the company when presenting the documentation. MOH may
accept or reject them on the basis of a risk assessment process.

*4. How frequently is the printed copy or website listing of MRLs
updated?*

MOH makes available an online database of authorized products. It is in
Italian and it is constantly updated:

<http://www.ministerosalute.it/alimenti/sicurezza/fitosanitari/ricerca.jsp>

MRLs are fed into the consolidated Italian text as they are approved. A
new comprehensive text is expected in July 2004.

*5. Is there a defined regulatory process for the establishment of
import MRLs?*

See EU rules referenced at the end of this report.

*6. What residues of pesticides define the MRL? That is, is only the
parent chemical measured or are specific metabolites included?*

Specific metabolites are included

*7. Are MRLs established for crop groups, individual crops or both?*

Both

***8. Does your country have a routine surveillance/testing program for
pesticide residues in imported foods? If so, please describe it, i.e.,
number of samples tested, how priorities are identified, are results
made available, sampling and testing procedures, etc.***

Surveillance/testing programs are done in accordance with EU Directive
89/397/CEE, which is implemented at country level with Decreto
Legislativo of March 3, 1993 number 123.

MOH coordinates the monitoring program and prescribes the minimum number
of samples to be analyzed by its regional and local units. The minimum
number of samples required in 2001 was 4,370 but the number of analysis
done that year was more than the double of it.

Results of the tests conducted by field offices of MOH are transmitted
electronically to a central office, they are also made available to the
public at a later date. Data for the year are to be sent to MOH by March
31 of the following year in order to send them to EU Commission.

***9. Does your country accept Codex MRLs? If not, do Codex MRLs play
any role?***

Italy accepts Codex MRLs as they are for very few products. Codex is
taken into consideration for product classification and, where no
country or EU MRLs are available, for deciding whether to allow or
reject imports of products from third countries.

***10. What actions are taken when residues are found above the MRL?***

## Depending on the seriousness of the offense, there could also be legal persecution. As far as imports are concerned, if they come from other EU member states they could be accepted if the shipment complies with MRLs in the country of origin. In some cases a conciliatory process between countries is activated at EU level.

In case of shipments from non-EU countries there could be a similar
conciliatory process between countries on the basis of Codex MRLs or
rejection of the shipments.

***11. Are there default pesticide enforcement levels? What are they?***

For those products that are not cultivated in Italy, if an EU MRL does
not exist, the default MRL is 0.01 mg/Kg.

Government Contacts:

EU law and updates:

<http://europa.eu.int.scadplus/leg/it/lvbl13007c.htm>.

Italian contacts:

Ministero della Salute

Direzione generale della sanita' veterinaria e degli alimenti

Palazzo Italia

Piazzale Marconi, 25

00144 EUR -- Rome

Italy

Dr. Roberti

T. +39 06 5994 6194

<f.roberti@sanita.it>