Detailed Twinning ‘light’ Project Fiche
Programme Title:
2006 Transition Facility Programme for Malta
Project Title:
Capacity Building in the field of Plant Protection Products and
Biocides
Project Number:
2006/18184.03.01
Twinning Number:
MT06/IB/EN/13/TL
BACKGROUND

Detailed Description of the Beneficiary Institution
The Malta Standards Authority was established in 2000 by virtue of Chapter 419 of the
Revised Edition of the Laws of Malta. With reference to Article 3 of Chapter 419, as last
amended by Act XXIX of 2007, the MSA has a legal personality distinct from that of
Government and its legal and judicial representation is vested in its Chairman:
“3. (1) There shall continue to be an Authority, to be called the Malta Standards Authority,
which shall exercise and perform the functions assigned to it by this Act or by any other law.
(2) The Authority shall have a Council which shall have the functions set out in subarticle
(2A) hereunder and which shall be composed as follows:(a) a Chairman, appointed by the Prime Minister;
(b) the Director of Industry ex officio who shall be Deputy Chairman;
(c) the Comptroller of Customs ex officio;
(d) the Director of Agriculture ex officio;
(e) the Director of Consumer Affairs ex officio;
(f) the Director (Environment Protection) ex officio;
(g) the Director (Public Health) ex officio;
(h) three members appointed by the Minister (i) one after consultation with the Kamra tal-Periti;
(ii) one after consultation with the Chamber of Professional Engineers, and
(iii) one after consultation with the Chamber of Pharmacists;
(i) a member appointed by the Council of the University of Malta;
(j) a representative of the Malta Council for Science and Technology, appointed by
the Prime Minister;
(k) a member appointed by the Chamber of Commerce;
(l) a member appointed by the Federation of Industries; and
(m) a member appointed by the General Retailers and Traders Union.”
The term of office of the Council is three years.
The Chairman is appointed by the Prime Minister and presides over the Board of Councillors
which is made up of members some of whom are appointed ex officio (such as the Director
Public Health, the Comptroller of Customs, etc…) while others are chosen by and from the
private sector body they represent (e.g. Chamber of Commerce). The term of office of the
Council is three years.
The executive function of the Authority is vested in the Chief Executive Officer (CEO) and
the technical functions of the MSA are vested in the Heads of Directorates, namely the
Regulatory Affairs Directorate (MSA-RAD), the Market Surveillance Directorate (MSAMSD), the Standardization Directorate (MSA-STD) and the Metrology Directorate (MSANMS). Since 2006 the National Accreditation Board (NAB-MALTA) was established and
has taken over the technical functions of the Accreditation Directorate. However the MSA is
still providing the administrative support and the necessary human resources support to the
NAB-MALTA.
The Central Administration (MSA-CA) caters for all human resources, financial and
administrative needs of the Authority. All the work is coordinated through the MSA-CA and
the CEO.
The staff of the MSA is actually made up of a Chief Executive, five Directors (four of whom
are engineers and the other a scientist), one Assistant Director, five engineers, one lawyer, one
financial controller, seven scientists and one trading standard officer, together with four
coordinating clerks. Presently the number of employees on the payroll of the MSA is 26.
Administrative Organigram:
Ministry of Finance,
the Economy and
Investment
MSA Chairman
and Council
Management
Committee
CEO
Regulatory Affairs
Directorate
(MSA-RAD)
Finance Office
Legal Office &
98/34/EC
Notification Point
Administration
Office
Help Desk
Market Surveillance
Directorate
(MSA-MSD)
Standardization
Directorate
(MSA-STD)
Metrology
Directorate
(MSA-NMS)
Accreditation
Directorate
(NAB-MALTA)
Regulatory Affairs Directorate (MSA-RAD)
The MSA-RAD, being one of the four functionally independent Directorates housed within
the MSA proposes new/amendments to existing technical regulations issued by virtue of the
Product Safety Act (Cap. 427), Food Safety Act (Cap. 449) and Pesticides Control Act (Cap.
430) as well as acts as the technical advisory arm of the Ministry of Finance, the Economy
and Investment (MFEI), Ministry for Social Policy (MSOC) and to the Ministry for Rural
Affairs and the Environment (MRRA) as well as to other Government entities, for all matters
related to the free movement and safety of goods.
These functions were formerly residing within two separate Directorates within the MSA
itself (Foodstuffs, Chemicals and Cosmetics Directorate and Consumer and Industrial Goods
Directorate) as well as within different Directorates within their respective Ministries
(Pesticides Control Unit within the Plant Health Directorate, Market Surveillance Directorate
and the Secretariat of the Food Safety Commission). Through the rationalization process
foreseen by Act XXIX of 2008 these responsibilities falling under the different entities were
amalgamated into the MSA-RAD as from 1 February 2008. Currently the MSA-RAD is
headed by a Director and the Directorate consists of two separate Units in order to deal with
the sometimes different approaches used in regulating certain product sectors. The Consumer
and Industrial Goods Unit (RAD-CIGU) deals primarily with product legislation falling under
the so-termed “New Approach” legislation whilst the Foodstuffs, Chemicals, Cosmetics and
Pesticides Unit (RAD-FCCPU) is responsible for regulating under the “Old Approach”
framework of legislation.
The Director is primarily involved in the consultation/negotiation process and the
development of European Directives insofar as policy issues are concerned, whilst the
technical members of the staff are involved in technical support matters.
Consumer and Industrial Goods Unit (RAD-CIGU)
The RAD-CIGU (established by means of Legal Notice 39 of 2008) is responsible for the
adoption and transposition of all New Approach Directives. Besides, it is also the regulator in
issues of product safety and issues related to conformity assessment bodies. It is also
responsible for the designation and notification of Conformity Assessment Bodies (CABs).
The RAD-CIGU proposes new/amendments to existing technical regulations issued by virtue
of the Product Safety Act (Cap. 427) as well as acts as the technical advisory arm for all
matters related to the free movement and safety of: Motor Vehicles, Electrical Equipment,
Radio Equipment and Telecommunications Terminal Equipment, Machinery and Mechanical
Devices, Personal Protective Equipment, Construction Products, Recreational Craft, Medical
Devices, Pressure Vessels, Toys, Pyrotechnic Articles and Gas Appliances. Set up by virtue
of the ‘Establishment of Directorates Order’ (L.N. 39 of 2008) after playing a crucial role
during Malta’s pre-EU accession negotiations on Chapter 1 (Free Movement of Goods), since
1st May 2004, the RAD-CIGU continued to support and even intensified its efforts towards
achieving those common regulatory requirements for products put on the Maltese and
European market, thus ensuring that goods can be traded freely. By virtue of the Malta
Standards Authority Act (Cap. 419) and the Product Safety Act (Cap. 427), the RAD-CIGU
also plays a “Risk Assessment” role in the overall Maltese market surveillance strategy and is
responsible for the designation and surveillance of notified bodies and other conformity
assessment bodies providing third-party inspections.
Today, the RAD-CIGU is composed of an Assistant Director (the post is still vacant) assisted
by four Engineers and a Scientist. One of the four posts for an Engineer is still vacant.
The duties of the RAD-CIGU, as prescribed by the pertinent Legal Notice, are as follows:
a)
b)
c)
d)
e)
to draft legislation in relation to the areas indicated in paragraph (e) hereof and
issued by virtue of the Product Safety Act and by any other law;
to advise the Minister, the Authority and other Government agencies and the private
sector, concerning this legislation and other matters ancillary thereto;
to assist all sectors of industry to understand and meet the essential requirements
imposed by technical regulations, issued by virtue of the Product Safety Act and by
any other law, and the technical, quality and safety requirements of harmonised
European and international standards issued by virtue of the Act;
to co-ordinate and implement the Authority’s regulatory and standardization
programmes in the areas indicated in paragraph (e) hereof and, in particular, to
exercise the advisory functions assigned to the Authority by virtue of the Product
Safety Act and by any other law;
to establish, with the consent of the Minister and of the Chairman of the Authority,
technical committees for the areas of competence hereunder indicated, and to chair
and co-ordinate the work of such committees relating to:1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
f)
g)
h)
i)
j)
k)
l)
Motor vehicles
Electrical risk and electrical equipment
Electromagnetic compatibility
Radio equipment and telecommunications terminal equipment
Energy efficiency requirements
Mechanical devices
Personal protective equipment
Construction products
Recreational sea craft
Medical devices
Pressure vessels
Toys
Gas appliances
Noise from vehicles and machinery
Pyrotechnics
to act as the focal point for any notification requirements involving the Authority,
for ensuring the free movement of goods principle;
to formulate and give effect to programmes of technical assistance aimed at business
operators for the purpose of facilitating their compliance with relevant technical
regulations and standards;
to communicate to the general public and to interested parties any information
regarding the Authority’s regulatory and standardization programmes in the areas of
competence indicated in paragraph (e) hereof;
to provide training and information on technical regulations and standards in the
areas indicated in paragraph (e) hereof;
to represent the Authority in relevant national and international activities;
to perform risk assessment and to co-ordinate market surveillance activities as
prescribed in article 27 of the Product Safety Act (Cap. 427);
to carry out such other functions as the Minister may, from time to time, direct.
Foodstuffs, Chemicals, Cosmetics and Pesticides Unit (RAD-FCCPU)
The RAD-FCCPU (also established by virtue of Legal Notice 39 of 2008) is responsible for
the transposition and adoption of all foodstuffs, chemicals, cosmetics and pesticides directives
and legislation. Besides, it also provides an advisory service to all manufacturers and
importers relating to the labelling of their foodstuffs products. The RAD-FCCPU is
represented on the Food Safety Commission, which is the body in Malta responsible for
administration and decision-making in the area of food safety. Through Act XXIX of 2007
the secretariat function of the Food Safety Commission has passed to this Unit. The RADFCCPU is also the competent authority in Malta in relation to (amongst other responsibilities)
labelling of foodstuffs, detergents, cosmetics and for REACH. It is currently the Competent
Authority for marketing limitations of dangerous substances, as well as for classification and
labelling of substances and preparations.
The duties of the RAD-FCCPU, as prescribed by the pertinent Legal Notice, are as follows:
a)
b)
c)
d)
e)
to draft legislation in relation to the areas indicated in paragraph (e) hereof and
issued by virtue of the Product Safety Act, Pesticides Control Act and the Food
Safety Act;
to advise the Minister, the Authority and other Government agencies and the private
sector, concerning this legislation and other matters ancillary thereto;
to assist all sectors of industry to understand and meet the essential requirements
imposed by technical regulations, issued by virtue of the Acts referred to in
paragraph (a) above, and the technical, quality and safety requirements of
harmonised European and international standards issued by virtue of the Act;
to co-ordinate and implement the Authority’s regulatory and standardization
programmes of standardization in the areas indicated in paragraph (e) hereof and, in
particular, to exercise the advisory functions assigned to the Authority by virtue of
the Product Safety Act, the Food Safety Act and by any other law;
to establish, with the consent of the Minister and of the Chairman of the Authority,
technical committees for the areas of competence hereunder indicated, and to chair
and co-ordinate the work of such committees relating to:1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
f)
g)
h)
i)
j)
k)
l)
Foodstuffs, including materials for their production
Water
Alcoholic beverages
Fertilisers and animal feedstuffs
Chemical substances, products and preparations
Medicinal and pharmaceutical products
Cosmetic products
Textiles and footwear
Glass, wood, paper and metal and products made there from
Packaging materials
Pesticides.
to act as the focal point for any notification requirements involving the Authority,
for ensuring the free movement of goods principle;
to formulate and give effect to programmes of technical assistance aimed at business
operators for the purpose of facilitating their compliance with relevant technical
regulations and standards;
to communicate to the general public and to interested parties any information
regarding the Authority’s regulatory and standardization programmes in the areas of
competence indicated in paragraph (e) hereof;
to provide training and information on technical regulations and standards in the
areas indicated in paragraph (e) hereof;
to represent the Authority in relevant national and international activities;
to perform those functions of the Food Safety Commission prescribed under article
7A of the Food Safety Act (Cap. 449);
to perform duties arising from the Pesticides Control Act (Cap. 430) and its
subsidiary legislation, namely:
1.
2.
3.
4.
5.
6.
Plant Protection Products Regulations (L.N.115 of 2004)
Maximum Residue Levels of Pesticides in Produce of Plant Origin
Regulations (L.N.199 of 2004)
Biocides Regulations (L.N.294 of 2004)
European Community Methods of Sampling for Official Control of
Pesticide Residues in and on Products of Plant and Animal Origin
Regulations (L.N. 479 of 2004) (This legal instrument only lays down the
methodology to be used)
Maximum Residue Levels of Pesticides in Produce of Animal Origin
Regulations (L.N.117 of 2005)
Activities concerning the Professional Use of Toxic Products Rules
(L.N.350 of 2005)
m) to carry out such other functions as the Minister may, from time to time, direct.
Under the Food Safety Act, the RAD-FCCPU has also been assigned a specific responsibility
for risk assessment. The RAD-FCCPU has also been designated as the competent authority
for the following areas of legislation:
a)
b)
c)
d)
e)
f)
g)
h)
i)
j)
k)
l)
Directive 67/548/EEC on the packaging, classification and labelling of dangerous
substances and on the notification of new chemical substances;
EC Regulation 793/93 on existing chemical substances;
Directive 91/155/EEC on material safety data sheets;
REACH Regulation (EC) No 1907/2006 of The European Parliament And Of The
Council of 18 December 2006 concerning the Registration, Evaluation,
Authorization and Restriction of Chemicals (REACH), establishing a European
Chemicals Agency, amending Directive 1999/45/EC and repealing Council
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well
as Council Directive 76/769/EEC and Commission Directives 91/155/EEC,
93/67/EEC, 93/105/EC and 2000/21/EC;
Directive 99/45/EC on dangerous preparations;
Directive 76/768/EEC on cosmetic products;
Directive 76/769/EC on the marketing limitations of dangerous substances;
EC Regulation 2003/2003 on fertilizers;
EC Regulation 648/2004 on detergents;
EC Regulation 510/2006 on the protection of geographical indications and
designations of origin for agricultural products and foodstuffs;
EC Regulation 509/2006 on agricultural products and foodstuffs as traditional
specialities guaranteed;
EC Regulation 1576/1989 on spirit drinks.
The RAD-FCCPU is responsible for transposing new acquis in the areas under its remit,
including coordinating all stages up to Ministerial approval. It is currently operating a help
desk facility for the areas under its remit. A substantial number of requests for assistance are
received on a regular basis.
The RAD-FCCPU staff also regularly performs technical audits on behalf of the
Standardization Directorate in the area of organic farming, as well as provide technical
support to other MSA Directorates and public authorities when and as required.
Today, the RAD-FCPUU is composed of an Assistant Director, assisted by four Scientists.

Context in the Beneficiary Country
As an EU Member State, Malta has to implement Directive 91/414/EEC on Plant Protection
Products (as amended) and Directive 98/8/EC on Biocidal Products (as amended). Malta has
already transposed these EU directives into national legislation and the Maltese Government
has designated the Malta Standards Authority as the competent authority responsible to
implement the obligations arising from these two directives.
Twinning project MT2002/IB/AG-02 ‘Capacity Building at the Plant Health Department’
established the minimum system requirements in order, amongst other issues, to register and
authorise Plant Protection Products (PPP) and to a lesser extent Biocide products. That
twinning project however, did not provide sufficiently extensive knowledge on the risk
assessment methodologies used in the field of Plant Protection Products (PPPs). All the
documentation that had been developed by the 2002 Twinning project has been handed over
to the Malta Standards Authority Regulatory Affairs Directorate (MSA-RAD). The
documentation comprises:


A Guide on Good Agricultural Practice
Relevant legislation, i.e.:
o
The Pesticides Control Act
o
The Plant Protection Products Regulations
o
The Maximum Residue Levels of Pesticides in Produce of Plant Origin
Regulations
o
The Maximum Residue Levels of Pesticides in Produce of Animal Origin
Regulations
o
The Biocides Regulations
o
The European Community Methods of Sampling for Official Control of
Pesticide Residues in and on Products of Plant and Animal Origin
Regulations, and
o
The Activities concerning the Professional Use of Toxic Products Rules
Two officers currently working within the MSA-RAD had benefited from some of the
training that had been given, particularly in relation to the procedure on the authorisation of
Plant Protection Products.
Moreover, the technical staff at MSA already has knowledge on the risk assessment of
dangerous substances as well as experience in the risk assessment methodologies applied in
the food sector. Nevertheless, in order to implement the PPP Directive, experts from MSA
need to be trained in the risk assessment methodologies used for the scientific evaluation of
dossiers submitted under Annex I of the Directive, inclusion of active substances, preparation
and commenting on prepared monographs of active substances, as well as for evaluating the
dossiers for new plant protection products at national level.
Similarly with respect to the Biocides Directive experts from MSA need to be trained on the
scientific methodology used in the risk assessment of biocidal products in accordance with
Directive 98/8/EC.
DESCRIPTION OF THE ASSIGNMENT

Overall Objective
Further strengthening of the Phytosanitary sector in accordance with the requirements of
Directive EC 91/414 and Directive 98/8/EC

Project Purpose
Strengthening the administrative and technical capacity of the Malta Standards Authority to
comply with the acquis requirements relating to Plant Protection Products and Biocide
Products

1.
The Mandatory Result
MSA experts involved in the scientific evaluation of dossiers capable of preparing
assessments and proposals for authorization of plant protection products and biocide
products in accordance with EU legislation and EU working practice for national
authorisation and in accordance with the EU review programme.

Assistance Sought from a Member State
It is envisaged that expert assistance would be provided through a Twinning ‘light’
arrangement with a counterpart organisation in an EU Member State. The following activities
are envisaged:
Project Coordination
Kick-off activity and final meeting during month 6. During the kick-off activity an
assessment of the current level of preparedness and expertise of the MSA-RAD staff will take
place.
Activity 1
Four 5-day STE visits to provide training on the latest risk assessment methodologies on
evaluation of the effects of Plant Protection Products in accordance with Directive
91/414/EEC and of Biocidal Products in accordance with Directive 98/8/EC.
Activity 2
Four 5-day STE visits to provide training on the scientific methodologies used in
exposure/emission assessment of Plant Protection Products in accordance with Directive
91/414/EEC and of Biocidal Products in accordance with Directive 98/8/EC
Activity 3
One 5-day STE visit on enforcement of the Plant Protection Products and Biocidal Products
Directives
Activity 4
One study visit of 5 working days for two officers in a MS competent authority for the Plant
Protection Products Directive to get hands-on experience with the methodologies used in the
risk assessment of PPP.
Activity 5
One study visit of 5 working days for two officers in a MS competent authority for the
Biocide Products Directive to get hands-on experience with the methodologies used in the
risk assessment of Biocide products.
EXPERTS’ PROFILE
The experts should have a minimum of 5 years’ experience on existing legislation in the field
of Plant Protection Products and Biocide Products in order to facilitate the transfer of knowhow to the MSA-RAD.
The experts are expected to have as a minimum a tertiary level of education as well as being
able to communicate in English.
IMPLEMENTATION ARRANGEMENTS
Accredited Implementing Agency:
Department of Contracts, Malta.
Contact Person:
Mr Bernard Bartolo
Assistant Director
Department of Contracts
Floriana
Malta
Tel: (+356) 2124 3847
Fax: (+356) 21247681
Email: [email protected]
Beneficiaries1:
Malta Standards Authority
Regulatory Affairs Directorate
2nd Floor
Evans Building
Merchants Street
Valletta VLT 1179
Malta
Project Leader:
Ing. Anthony Camilleri
Chief Executive Officer,
Tel: +356 2124 2420
Fax: +356 2124 2406
Email: [email protected]
Location and Duration
Starting date2
15 December 2008
Finishing date of the assignment
30 June 2009
1
In terms of the definitions contained in the Memorandum of Understanding for the Implementation of
the Transition Facility, the Beneficiary is the ‘Implementing Agency’
2
Cannot be before the date of signature of the Twinning ‘light’ contract
REPORTING
Start-up report in English covering the first two months of the contract (submitted during
the third month).
A final report in English in terms of section 6.4.3 of the 2007 Reference Manual on
Twinning Projects, accompanied by an audit certificate from a recognised independent
auditor.
The reports should follow the template for standard Twinning and must be endorsed and
countersigned by the Beneficiary, who may make additional comments.
The reports should be submitted to the Department of Contracts and the Beneficiary, with a
copy to the Twinning Coordination Team at the European Commission Headquarters.
BUDGET
Total Budget Available: €57,500
Log Frame
LOGFRAME PLANNING MATRIX FOR
Project
Capacity Building in the field of Plant Protection Products and Biocides
Programme name and number:
2006 Transition Facility
Contracting period expires
15 December 2008
Total budget: €57,500
Project execution period
expires:
15 December 2009
TF budget: €57,500
Overall objective
Further strengthening of the Phytosanitary sector in
accordance with the requirements of Directive EC
91/414 and Directive 98/8/EC.
Objectively verifiable indicators
 Minimisation of business disruption to
local applicants for the authorisation/
registration of Plant Protection
Products and Biocide Products.
 Fulfilment of the obligations falling
under the relevant legislation by the
Malta Standards Authority.
Sources of Verification
 Trade statistics
Project purpose
Strengthening the administrative and technical
capacity of the Malta Standards Authority to comply
with the acquis requirements relating to Plant
Protection Products and Biocide Products.
Objectively verifiable indicators
 Development of the relevant risk
assessment capabilities.
Sources of Verification
 Final Audit Report
Assumptions
 Retention of adequate
staffing levels
Results
MSA experts involved in the scientific evaluation of
dossiers capable of preparing assessments and
proposals for authorization of plant protection
products and biocide products in accordance with EU
legislation and EU working practice for national
authorisation and in accordance with the EU review
programme.
Objectively verifiable indicators
Sources of Verification
 MSA-RAD actively participating in the  Trade statistics
meetings organised by the European
 Final Audit Report
Commission.
 Increased competency of staff in the
field of risk assessment.
 Minimisation of business disruption for
local applicants for the authorisation/
registration of Plant Protection
Products and Biocide Products.
Assumptions
 Retention of adequate
staffing levels
Activities
Means
Activity 1
 Twinning ‘light’ contract
Four 5-day STE visits to provide training on the latest
risk assessment methodologies on evaluation of the
effects of Plant Protection Products in accordance
with Directive 91/414/EEC and of Biocidal Products
in accordance with Directive 98/8/EC.
Assumptions
 Retention of adequate
staffing levels
Activity 2
Four 5-day STE visits to provide training on the
scientific methodologies used in exposure/emission
assessment of Plant Protection Products in
accordance with Directive 91/414/EEC and of
Biocide Products in accordance with Directive
98/8/EC.
Activity 3
One 5-day STE visit on enforcement of the Plant
Protection Products and Biocide Products Directives.
Activity 4
One study visit of 5 working days for two officers in
a MS competent authority for the Plant Protection
Products Directive to get hands-on experience with
the methodologies used in the risk assessment of
PPP.
Activity 5
One study visit of 5 working days for two officers in
a competent authority for the Biocide Products
Directive to get hands-on experience with the
methodologies used in the risk assessment of Biocide
products.
Preconditions
 Staff recruitment concluded