Promoting consumer safety 1

Promoting consumer safety 1. Basic Information

1.1 CRIS Number: 2005/017-488.02.06 1.2 Title: Promoting consumer safety 1.3 Sector: Internal Market 1.4 Location: Poland

2. Objectives

2.1 Overall Objective(s): • ensuring the same high level of consumer safety as exists in the EU-15

2.2 Project purpose:

• reinforcement of consumer safety through further strengthening of professional competencies of Trade Inspection individuals and ensuring appropriate laboratory technical facilities

2.3 Justification

With reference to Comprehensive Monitoring Report on Poland’s preparations for membership (from November 2003): Chapter 23 Consumer and health protection. In the field of Market surveillance relating to general product safety “Poland is completing the relevant policy management structures and information system. However, the capacity of the main bodies in charge of market surveillance activities needs to be further developed and their co-ordination improved. These structures need also to be strengthened in terms of both financial and human resources.” (2003 Comprehensive Monitoring Report) With respect to market surveillance the project aims to strengthen control ability of Trade Inspection laboratories in line with the EU requirements. The practical knowledge and equipment provided will enhance the position of the Trade Inspection and the OCCP in the market surveillance system, esp. in the field of consumer safety. 3. Description

3.1 Background and justification:

The activities proposed within this project will support further improvement of consumer safety by strengthening the capacity of the Trade Inspection (esp. TI laboratories) and testing personnel as well as will focus on upgrading skills and professional qualifications of consumer protection individuals. Since 2001, in the Trade Inspection, the structure of laboratories’ system in Chief Inspectorate has been changed – the significant change /moving the laboratories activities toward fast and precise methods of instrumental analysis, creating new laboratories closer to acquis communautaire requirements- were based on technical support from Phare 2000, 2001, 2002.

Promoting consumer safety 2

Transition Facility program is the most important possibility to finish the process of modernization of Chief Inspectorate’s laboratories and to change their methodology toward modern instrumental analysis and especially hyphenated techniques.

All activities in the TF 2005 are result-oriented and do not overlap - their specification for investment part is based on the existing gaps and related to them legal obligations. Some activities proposed in the project are built on previous Phare and TF 2004 projects:

• specially tailored training courses or continuation of specific subjects for TI;

• support for TI laboratories by up-to-date equipment - subsidiary to those performed/to be performed under 2002 Phare and TF 2004 projects.

A. Laboratory equipment for the Trade Inspection laboratories The up-to-date laboratory equipment is needed as a consequence of enforcement of new acts and regulations transposing EU requirements to Polish law as well as newly introduced EN and ISO norms for analytical methods. Especially so called “hyphenated techniques” like LC-MS and GC-MS are of great importance due to joining in the same apparatus identification and quantification of substance as well as making analyses time- and cost-saved. Moreover, as a result of implementation of new regulations and provisions, it is indispensable to supplement possessing apparatus with complementary accessories like special guard columns and columns for GC and HPLC, ovens and pumps for HPLC and LC-MS, chemical ionisation module for GC-MS etc. The risk of presence on the Polish market of non-labeled food products derived from genetically modified organisms (GMO) is very high, thus the Trade Inspection should expand the scope of investigations to tests of food products via molecular level methodologies like polymerase chain reaction (PCR) – DNA amplification and tests ELISA. It should be stressed that in order to be fully operated modern laboratory equipment requires up-to-date and efficient support devices as redistilling water units, ultra pure water systems, pH-meter and conductometer, vacuum rotary evaporators, technical scale balance, cryoscope, fume cupboard (hood) etc. as well.

The area of consumer safety needs further development and support esp. in the scope of consumer goods testing (as a counterbalance to false advertising phenomena), therefore the involvement of TI laboratories (covering a wide range of test methods, e.g. in the fields of safety of textiles, safety of toys and quality of cosmetics etc.) is necessary. One of the best examples of institutions that are dealing with consumer safety issues is the Stiftung Warentest in Germany. However, all test activities need laboratories that will be equipped with efficient and up-to-date devices, especially with instrumental analysis apparatus like: AAS, HPLC, LC-MS, FTIR in order to use more precise and time-saving techniques. Among the institutions of consumer safeguarding system the laboratories are the most effective, but an expensive tool nevertheless. Equipment listed below will allow for a comprehensive instrumental analysis with a chemical wide scope enabling an identification of chemical substances as well as for their quantitative determination.

In details, the current project concerns purchase of the latest analysis equipment such as LC/MS – liquid chromatography with mass spectrometry, which is not in possession by

Promoting consumer safety 3

any of the Trade Inspection Laboratories. LC/MS will find the use in broad range of TI investigations in various products (mainly food), such as:

1. Vitamins in: juices and food for children 2. Colorants in; fruit juices, wines, dairy products, cured meats, seasonings and

spices 3. Sweeteners and preservations in; beverages and juices, dairy products, vegetable

products, fishes, wines 4. Carbohydrates: honey, juices and other fruit products 5. Aminoacids: fruit juices

Non-food: 1. Textile: azo dyes in playthings 2. Cosmetics: confirmation of qualitative and quantitative composition

Formaldehyde Vitamins Sodium iodate in rinse off cosmetics Benzyl alcohol

Hexamidine, dibromohexamidine, dibromopropamidine, chlorhexidine in cosmetics Benzoic acid, sorbic acid, salicylic acid Unlike the HPLC methods used until now, LC/MS analysis is quicker and gives the possibility of qualitative and quantitative determinations. Additional advantage of that method is its possibility of quick validation towards HPLC. Advantages similar to LC/MS method are also characteristic for gas chromatography combined with mass spectrometry (GC/MS), which are: quick analysis, qualitative and quantitative determinations, validation, repeatability, accuracy. There is one GC/MS set as a part of IH laboratory instrumentation. However, it is not sufficient in relation to the great number of necessary analysis. Besides, there is a constant need for more extensive research, as a result of new legislation being permanently under changes, which also requires new control procedures. Proposed chemicals to analyse on GC/MS

1. Fat acids, waxes and sterols in oil from olives 2. Fats and oils: their authenticity conformation in chocolate products, in vegetable

oils and fats throughout fat acids profile analysis 3. Alcoholic drinks authenticity conformation through methanol and fusel oils

analysis 4. Organic acids in wines to confirm their authenticity 5. Coffee quality analysis 6. BTEX volatile substances in textiles 7. Phthalic acid in playthings made from PVC 8. In cosmetics: resorcine in shampoo and hydrogen peroxide

FTIR – there is no such instrument in any laboratory currently. The use of this apparatus allows for fast analysis of new generation fibres and detection of adulterations in textile raw materials. Thus the FTIR method enables quick validation in reference with currently used methods, in accordance with regulations on safety and marking of fibre materials. PCR techniques enable authenticity estimation of food products by DNA analysis. In IH laboratories there is no such analytical equipment. PCR method is useful in determination:

1. Authenticity of such products as; meats, poultry, fish, dairy products 2. GMO products

Promoting consumer safety 4

ELISA – is very specific, sensitive and selective method. It enables to confirm the origin of such products as; dairy products, meats or cereals by gluten content determination. The remaining instruments are indispensably with reference to the need of replacement of spent accessory equipment such as; fume extractor, ventilated closets for reagents, water purification systems, pH meters, and conductometers. However, the accessories for HPLC and GC are necessary in order to introduce new type of researching methods resulting from EU legislation.

JUSTIFICATION (ANALYSES)In the “Transition Facility” 2005 program, The Chief Inspectorate of Trade Inspection acknowledged as a priority to equip its laboratories in modern equipment such as liquid chromatography combined with mass spectrometry (LC/MS), or gas chromatography with mass spectrometry (GC/MS), and also PCR, FTIR (Fourier Transform Infrared Spectroscopy). The table with detailed needs assessment is presented in the Annex 5. Apart from one GC/MS unit in Łódź Instrumental Analysis Laboratory, which was received under PHARE 2002 Program, the Trade Inspection does not posses any other units of this type. One GC/MS set is not sufficient for TI laboratory basis in the context of quick response to the market signals and legislation changes. The cost of this instrument is far beyond the institution’s sources which are available from the Budget. In laboratories within EU countries such instrumentation is widely in use and represents the basis of analytical equipment.

The instruments of the type described above allow the extension of the range of analysis. They also enable introduction of new parameters to be analysed within the Trade Inspection laboratories, according to EU legislation, which is a patter for adequate domestic acts. The new legislation in force imposes quality and safety check on foods and other goods. Unlike the methods of analysis used so far in the laboratories of Trade Inspection, such as high performance liquid chromatography (HPLC), gas chromatography (GC), ASA and the new methods such as LC/MS enable quick analysis with qualitative and quantitative determination, as well as methods of validation for accuracy and repeatability taken into account. Laboratories of the Trade Inspection dispose six gas chromatographs made in 1995 that are used in significant scope and first of all often fail. Owned gas chromatographs enable limited possibilities in many parameters examination. The examinations concern methanol and fusel determination in alcoholic beverages. These chromatographs do not allow for quick new analysis implementation for sterols, waxes and fat acids determination. The Trade Inspection laboratories seem to have a better situation in the field of applied HPLC methods. That was mostly possible due to help of PHARE fund. However there is still much to be done, especially in the aspects of equipment upgrade, together with use of new analysis methods based on new kinds of detectors and apparatus. Equipment for non-food laboratories. FTIR set would be very useful in the segment of non foods items testing, particularly it will be utilised in artificial fibre materials testing (forgery detection). In the IH laboratory equipment there is lack of such device.

Promoting consumer safety 5

CI (Chemical Ionization Module) for GC/MS enables quick detection of volatiles and toxic substances in fibre materials (BTEX), according to the legislation presented in the table. LC/MS permits the possibility of quick determination with use validation and accuracy of aromatic amines examination methods in azo dyes, formic aldehyde, and phthalates in playthings. Accessories such as GC Autosampler, SPME-Headspace, GC columns and GC-Thermodesorber will replenish the chromatography equipment that is currently in Łódź laboratory. The apparatus mentioned above will be also in practical use for playthings and textile testing for phthalates presence. These kinds of tests are done only by the Trade Inspection, according to adequate regulations. Equipment for food laboratories. LC/MS set will be mostly allocated for foods testing for the presence fake sweeteners, preservatives and carcinogenic substances such like synthetic dyes “Sudan” type in seasonings (added to products of fast food type). These substances are very difficult to detect with the equipment currently used in The Trade Inspection laboratories. A new challenge for TI is olive oil sensory testing as well as oil quality check testing. Such tasks require new generation instrumentation, GC/MS or LC/MS type, and to equip sensory laboratory with proper cabins. At present TI food laboratories do not possess such equipment. Ten-year old gas chromatographs do not allow for extensive examination, such as sterols, waxes and fat acids determination. The examinations listed above, done for the market requirement control, were attributed to TI. There is also a need for a team of trained tasters who are needful for oil sensory examinations, according to certain EU directives. A new unique analytical device proposed is a set that utilise PCR technique. That technique is based on DNA analysis and enables broad range of meat, poultry, fish and dairy products testing. Food products examinations on GMO will also belong to the TI competency, according to the new act on IH. Unfortunately, TI does not have such equipment as well. Another important issue is elementary equipment replacement, such as water purification systems (essential in every kind of laboratory), pH meters, conductometers, vacuum pumps, SPE systems for sample preparing for HPLC, filtration systems. Such equipment must be replaced on regularly base. Despite the fact that considerable amount of financial sources from PHARE fund was spent for TI, there are still laboratory equipment shortcomings. New legislation imposed by EU directives is often far away compared to the examination abilities of some laboratories – subsidised mainly through PHARE resources.

B. Specialised training for testing personnel

Introduction of new analysis methods, particularly on new generation equipment, require not only new equipment to be with accordance with EU legislation, but it also involves TI laboratory personel to be trained in the subject of new equipment use and examination standards.

Promoting consumer safety 6

The TA contract will cover comprehensive and very specialised training for the testing personnel and laboratories’ employees on analytical methods and consumer tests methodology. A very essential issue is to train a team of tasters for oil sensory analysis to check its authenticity. At present there is no such team in Poland. The oil market from olives will be the duty range of TI. As the priority tasks in the domain of trainings on examination methods one can include subjects connected with food analysis by PCR technique and GMO content analysis. The other topics of trainings are strictly relevant to new offers of LC/MS and GC/MS equipment purchase.

3.2 Linked activities:

The Office of Competition and Consumer Protection has benefited from the following assistance in the area of consumer policy:

Phare 2000, PL0004.03 Competition and Consumer Protection: the main focus of the project was to set up a base for Polish market surveillance system consistent with the EU guidelines (creation of a data base). The consumer part of the project provided assistance to improve enforcement procedures, and to improve of the professional skills of the OCCP staff, consumer ombudsmen and consumer associations. A large number of practical training courses on cases and EU law were provided by Finnish and French experts. The project (i.e. the last component – twinning covenant) was completed on 21 August 2003. The results envisaged by this project created the basis for certain activities foreseen in PHARE 2003.

Phare 2001, PL0102.05 Competition Policy and Consumer Protection: the project included competition and consumer protection issues, and an additional component dedicated to state aid issues (Technical Assistance). The main part was a follow-up of Phare 2000 It focused on strengthening consumer awareness in Poland through grants to consumer associations), and on improving professional skills of OCCP and TI staff and of consumer ombudsmen based on German and Austrian experience (twinning component, ref. no. PL/IB/2001/EC/08). The project (i.e. the last component – twinning covenant) was completed on 15 October 2004. The German and Austrian support was used for activities related to consumer associations (German support in creating the concept of a Polish infothek; Austrian/German support in creating concept of infoline). The German Stiftung Warentest, independent testing Institute assisted in developing expertise in comparative testing.

Phare 2002, PL2002/000-605.02.01 Market Surveillance – the project focuses on reinforcing the existing market surveillance technical infrastructure and on improving Polish public administration qualifications and skills in the field of New Approach Directives (five investments’ contracts for market surveillance bodies and one Technical Assistance contract). This project was planned as a follow-up of Phare 2000. It involves the OCCP and four other agencies which are i.a. responsible for the effective functioning of market surveillance in Poland. These include: Trade Inspection (IH), Office of Telecommunications and Post Regulation (URTiP), National Labour Inspectorate (PIP) and State Mining Authority (WUG). The training to be undertaken under the Transition Facility is a follow up to the training under the 2002 Phare project and will focus on specific laboratory control capacities. The 2002 Phare project i.a. covered upgrading professional skills of the market

Promoting consumer safety 7

surveillance personnel through specialised training on new approach directives, harmonised technical norms and standards, and further developments in this respect.

Phare 2003, PL2003/004-379/01.10 Strengthening the Consumer Protection Policy The main goals of this project are: effective protection of consumer rights and interests by OCCP, consumer associations, consumer ombudsmen and conciliation courts, and raising awareness of consumer rights. The main actions to achieve these goals include strengthening of relevant mechanisms (Technical Assistance) and equipment (Investment component – purchase of IT equipment) as well as education and information activities (contracts for information/education campaign, training courses for OCCP officials and consumer ombudsmen). The improved technical infrastructure (purchase of IT equipment and creation of database) supporting the daily activities of bodies involved in consumer protection will help to achieve the objectives planned under TF 2004.

Transition Facility 2004, Consumer protection system – the project focuses on strengthening professional competencies of consumer protection executives (OCCP, Trade Inspection and ombudsmen) and representatives of consumer NGOs as well as on strengthening the conciliation courts’ arbiters’ professional skills. The other main goals of this project are: enhancing the involvement and the contribution of consumer associations to consumer protection system, providing reliable market surveillance and product safety data and information, increasing the level of consumers’ and businesses’ awareness of their rights and responsibilities as well as promoting consumer interests and rights.

3.3 Results:

The project, in line with its objectives, should bring the following results: Contract 1 – Investments • envisaged equipment purchased and delivered to laboratories to reinforce testing

capacity of TI laboratories in the scope of new analytical methods – obligations resulting from binding legislation fulfilled.

Contract 2 – TA 1 – specialised training for testing personnel • min. 100 persons responsible for testing trained on specific laboratory analytical

methods in the light of new regulations and consumer tests methodology.

3.4 Activities:

1) 3.4.1. Contract 1 – Investments – laboratory equipment for the Trade Inspection laboratories To implement acquis communataire effectively and according to several newly issued Polish acts and related regulations in the field of Market Surveillance System and product quality and safety a conditio sine qua non of putting such legislation tools into the practice of laboratories is to possess a present-day equipment.

Promoting consumer safety 8

The purchases of the equipment from Transition Facility 2005 programme are based on an analysis of already possessed by TI equipment, the EU directives, regulations (mentioned below) and Polish acts as well as on existing gaps (obligations – possibilities) to establish a good conditions to develop analytical methods (see Annex 5) and appropriate Quality Manual procedures. All of these needs require well-equipped laboratories, especially with instrumental analysis apparatus like AAS, HPLC, LC-MS, FTIR, in order to perform more precise and time-saving techniques.

The issues with production of food and food market in Poland are regulated by: • Act of 11 May 2001 on health conditions of food and nutrition (Official Journal of

2001 No. 63, item 634 with amendments); • Act of 21 December 2000 on trade quality of agricultural products and food

(Official Journal of 2001, No. 5, item 44 with amendments).

These acts are supported by detailed Regulations of Minister of Agriculture: • essential requirements in market quality area of cocoa and chocolate-products

(OJ of 2002, No. 214, item 1813 with amendments), • essential requirements in market quality sphere of coffee extracts and succory

extracts (OJ of 2003, No. 52, item 463 with amendments), • essential requirements in market quality sphere of bee honey (OJ of 2003, No.

181 item 1773 with amendments), • essential requirements in market quality sphere of jams and gellys made from

fruits (OJ of 2003, No. 143 item 1398 with amendments), • essential requirements in market quality sphere of fats and vegetable oils and

foodstuffs containing added oils or fats (OJ of 2004, No. 97 item 974), • essential requirements in market quality sphere of fruit juices and nectars (OJ of

2003, No.177 item 1735 with amendments). Many separate Regulations on the European Community level are used in market surveillance directly, without transposition to the Polish legislation. Several of these – most important for Trade Inspection areas of interest are mentioned below:

• Council Regulation (EEC) No 1898/87 Document Number: EEC 1898/87/EEC European Union 02-Jul-1987 with amendments,. Description: Council Regulation (EEC) No 1898/87 on the protection of designations used in marketing of milk and milk products

• Commission Regulation (EC) No 577/97 Document Number: EEC 577/97/EC European Union 01-Apr-1997 with amendments. Description: Commission Regulation (EC) No 577/97 laying down certain detailed rules for the application of Council Regulation (EC) No 2991/94 laying down standards for spreadable fats and of Council Regulation (EEC) No 1898/87 on the protection of designations used in the marketing of milk and milk products

Examples of regulations for wines and spirit drinks:

• Council Regulation (EC) No 1493/1999 Document Number: EEC 1494/1999/EC 17-May-1999, Council Regulation (EC) No 1493/1999 on the common

Promoting consumer safety 9

organisation of the market in wine

Examples of regulations for fats and oils implemented by (mentioned above)

• Council Directive 76/621/EEC Document Number: EEC 76/621/EEC 20-Jul-1976, Council Directive 76/621/EEC relating to the fixing of the maximum level of erucic acid and oils and fats intended as such for human consumption and in foodstuffs containing added oils or fats

• Commission Directive 80/891/EEC Document Number: EEC 80/891/EEC 25-Jul-1980, Commission Directive 80/891/EEC relating to the Community method of analysis for determining the erucic content in oils and fats intended to be used as such for human consumption and foodstuffs containing added oils or fats

Examples of regulations for Genetically Modified Organisms (GMO)

• Act of 22 June 2001 on GMO (Official Journal of 2001, No. 76 item 811 with amendments)

A separate area concerns food additive substances – sweeteners, colorants, flavors, preservatives – the list of these substances is placed in Annex to Regulation of Minister of Health of 23 April 2004 (Official Journal of 30 April 2004, No. 94 item 933) and food contaminants.

Envisaged purchases of equipment meeting directives provisions:

No. Name Quantity 1. LC-MS apparatus 1 2. GC-MS apparatus with EI and CI ionisation modules 1 3. HPLC with DAD detector 1 4. Sensoric cabinet 1 5. PCR technique equipment 1 6. HPLC accessories:

Oven CLASS VP compatible Pump CLASS VP compatible Columns Guard columns Column for bee honey analysis Refractometric detector CLASS VP software compatible

1 1 4 3 1

1 7. Thin Layer Chromatograph set (TLC) 1 8. ELISA tests reader 2 9. pH-meter with conductometer 1 10. Redistilling water unit 6 11. Millipore ultrapure water system 5 12. Vacuum rotary evaporator 3 13. Technical scale balance 1 14. Cryoscope 2 15. Fume cupboard /hood/ 3 16. Solid Phase Extraction set (SPE) 1

Promoting consumer safety 10

On the area of non-food consumer products safety since April 2004 until now have been issued several new regulations: • Act of 19 April 2004 on textile products safety and labeling (OJ of 2004, No. 81

item 744), • Act of 14 November 2003 on essential requirements for toys (OJ of 11 December

2003, No. 210 item 2045), • Act of 6 April 2004 on products containing phthalates which cause serious threats

(OJ of 2004, No. 73 item 656), • On the basis of article 31 of Act of 11 January 2001 on chemical substances and

reduction of chemical risk factors, Minister of Economy and Labor has prepared Regulation of 5 July 2004 (OJ of 28 July 2004, No. 168, item 1762) concerning exclusions, limitations and conditions of production, using and offering to consumers many dangerous chemical substances – in pure form and in products containing them. The Regulation details a list of substances banned from products, limited in products and conditions of their production, using and offering on the market. However, some articles of this Regulation will come into force at the beginning of 2005.

Envisaged purchases of equipment meeting directives provisions:

No. Name Quantity 1. LC-MS apparatus 1 2. Chemical Ionisation module for GC-MS 1 3. FT-IR apparatus 1 4. GC accessories:

Autosampler/Headspace/SPME Columns Guard columns set Gas pressure reductors Thermodesorber

1 2 2 5 1

6. HPLC accessories: Oven CLASS VP compatible Pump CLASS VP compatible Columns Guard columns DAD detector CLASS VP compatible Controller CLASS VP compatible Filters set Digital/analog interface CLASS VP compatible Degasser

1 2 1 3

1 1 1

1 1

7. pH-meter + conductometer 1 8. Redistilling water unit 1 9. Millipore ultrapure water system 1 10. Vacuum rotary evaporator 1 11. Thin Layer Chromatograph set 1

In the field of cosmetics: Act of 30 March 2001 on cosmetics (OJ of 2001, No. 42 item 473). This Act is supported by detailed Regulations of Minister of Health: • of 12 June 2002 on list of chemical substances, banned and limited in cosmetics (OJ

of 12 July 2002, No. 105 item 934),

Promoting consumer safety 11

• of 16 July 2004 on sampling procedures and analytical procedures concerning cosmetics (OJ of 22 September 2004, No. 206 item 2106).

Envisaged purchases of equipment meeting directives provisions:

No. Name Quantity 1. Millipore ultrapure water system 1 2. Redistilling water unit 1

ESTIMATED TOTAL VALUE AND NUMBER OF LABORATORY

EQUIPMENT

No. Name Unit price (in Euro) Quantity Total

(in Euro)

1 LC-MS apparatus 152 500 2 305 0002 GC-MS apparatus with EI and CI modules 66 000 1 66 0003 HPLC + DAD detector 45 000 1 45 0004 CI module for GCMS 21 000 1 21 0005 FT-IR apparatus 19 000 1 19 0006 HPLC refractometric detector CLASS VP

compatible 10 000 1 10 000

7 HPLC column for bee honey analysis 2 000 1 2 0008 HPLC oven CLASS VP compatible 3 900 2 7 8009 HPLC pump CLASS VP compatible 6 000 3 18 000

10 HPLC Guard column 330 6 1 98011 HPLC Column 600 5 3 00012 HPLC DAD detector CLASS VP compatible 15 000 1 15 00013 HPLC Filters set 700 1 70014 HPLC Controller CLASS VP compatible with

interfaces 9 000 1 9 000

15 HPLC Digital/analog interface CLASS VP compatible

800 1 800

16 HPLC Degasser 2 800 1 2 80017 GC Autosampler/ SPME Headspace/ 15 000 1 15 00018 GC Columns 2 000 2 4 00019 GC Guard columns set 800 2 1 60020 GC Gas pressure reductors 500 5 2 50021 GC Thermodesorber 7 600 1 7 60022 TLC set 6 500 2 13 00023 Sensoric cabinet 4 000 1 4 00024 PCR technique equipment 35 800 1 35 80025 ELISA tests reader 6 000 2 12 00026 Millipore ultrapure water system 4 000 7 28 00027 Redistilling unit 2 100 8 16 80028 pH-meter + conductometer 2 000 2 4 00029 Vacuum rotary evaporator 5 000 4 20 00030 Technical scale balance 1 000 1 1 00031 Cryoscope 5 500 2 11 00032 Fume cupboard /hood/ 10 500 3 31 50033. Solid Phase Extraction Set (SPE) 1 000 1 1 000

Total gross value: 735 880 €

Promoting consumer safety 12

3.4.2. Contract 2 – TA (specialised training for testing personnel)

In order to assure the similar level of consumer safety as exists in the EU-15the following training courses for TI laboratories’ employees should be conducted:

A. FOOD RELATED TRAINING 1. Sensory analysis of olive oil – authenticity aspect according to EEC Regulation 2. PCR technique in meat and GMO analysis 3. ELISA tests as a tool for GMO quantification in food products 4. Authenticity of wines and spirits via GC-MS technique 5. Sensory analysis of coffee – techniques and principles 6. GC-MS determination of flavors and volatiles in juices and determination of

hydrocarbons in purified vegetable oil 7. LC-MS and GC-MS determination of products of steroles dehydratation; LC-MS

and GC-MS determination of isothiocyanate in wines and aromatic chemical substances in juices, drinks, fruit preserves, ripening cheeses

8. Confirmation of juice authenticity by determining of ratio of isotopes 9. Application of laboratory statistics, analytical methods validation, estimation of

measure uncertainty B. NON-FOOD RELATED TRAINING 1. Estimation of chemical risk, sampling procedures, chemical screening in non-food

consumer products especially in textiles and toys 2. Hyphenated techniques like GC-MS, LC-MS, GC with SPME and Headspace,

FTIR and fluorescence in safety of product analysis. 3. SPE technique in environmental samples – reversed phase and polymer sorbents 4. AAS apparatus exploiting – with suspension technique in graphite furnace

atomization C. COMPARATIVE TESTING RELATED TRAINING

Moreover, the contract will cover 20 training sessions on methodology of consumer goods testing (regarding a wide range of products, e.g. electrical devices, household products, cosmetics and foodstuff etc.).

3.5 Lessons learned:

With reference to Interim Evaluation No. R/PL/INT/02101, date: 24 June 2003 made by EMS Poland, the following conclusions and recommendations were considered in the process of project design: • point 53, p. 12: “PL0004.03 and PL0102.05 should increase the provision of

consumer protection however the capacity of the OCCP and associated institutions need to be further developed to provide effective consumer protection comparable with Member States.”

• point 81, p. 17: “The institutions with responsibility for market surveillance, generally, have been created more recently and are not as advanced as their

Promoting consumer safety 13

conformity assessment counterparts. Nevertheless progress can be reported in this area also and, assuming institutional stability, governmental support and continued support and cooperation with MS institutions, the prospects for achieving and maintaining compliance with EU standards are good.”

On the basis of experience in all OCCP’s Phare and TF projects the current project is designed to avoid previous problems and obstacles, such as becoming outdated due to long period between design and implementation.

Moreover, the specification for investment part is based on the laboratories’ existing gaps (Annex 5) as well as is built on previous Phare projects. Support within TF 2005 for TI laboratories by providing up-to-date equipment - is subsidiary to purchases done under Phare 2000, 2001 and 2002.

Phare 2000, PL0004.03 Competition and Consumer Protection:

The following devices were purchased: microscopes, tensile testing machine, ultrasonic baths, titrators, UV/VIS spectrophotometers, HPLC gradient systems, centrifuges digestors and fume cupboards etc. When the list within TF 2005 was created, the specification of Phare 2000 was used as the background for it, in order to avoid any overlapping or duplication of expenditures.

What is more, in that time due to the modification of the organisational structure of TI laboratories the number of laboratories decreased and areas of their specialisation were revised - therefore it was indispensable to verify the distribution list of laboratory equipment to deliver adequate devices to the relevant laboratories. When drafting TF 2005 all necessary steps in order to avoid any problems resulting from foreseeable for the time being changes were made.

Phare 2001, PL0102.05 Competition Policy and Consumer Protection

When the list within TF 2005 was created, the specification of Phare 2001 was used as the background for it, in order to avoid any overlapping or duplication of expenditures.

Phare 2002, PL2002/000-605.02.01 Market Surveillance As in the 2000 and 2001, when the list within TF 2005 was created, the specification of Phare 2002 was used as the background for it, in order to avoid any overlapping or duplication of expenditures. What is more, one of the most important lessons learned from 2002 project, is that the tender procedure should be opened as early as possible in order to have enough time to repeat procedure in case of any problems (in 2002 project Lots 2, 3, 4, 5 and 12 were not awarded during the first tender procedure. Therefore having in mind the importance of the project, the OCCP and Trade Inspection asked to open the local tender procedure for remaining laboratory equipment as the time frame allowed for such request and the required equipment was purchased. 4. Institutional Framework

The Office of Competition and Consumers’ Protection will co-ordinate the project in its capacity of government consumer protection and market surveillance authority. The Department of Foreign Assistance, Budget and Administration, is responsible for the overall co-ordination of the project (under Transition Facility 2005). The direct beneficiary is the Trade Inspection and its laboratories.

Promoting consumer safety 14

5. Detailed Budget

€M Transition Facility support Co-financing Total

cost (TF plus

cofinancing) Invest-

ment Support

Institu- tion

Building

Total Transition

Facility (=I+IB)

National Public

Funds (*)

Other Sources

(**)

total co-financing

of the project

Contract 1 – Investments

0,555 0 0,555 0,185 0 0,185 0,74 Contract 2 – TA training for testing personnel

0 0,30 0,30 0,03 0 0,03 0,33

Total 0,555 0,30 0,855 0,215 0 0,215 1, 070 (*) contributions form National, Regional, Local, Municipal authorities, FIs loans to public entities, funds from public enterprises (**) private funds, FIs loans to private entities All contracts are jointly co-financed. In case of Joint Co-financing, where the final overall cost is lower than foreseen in the project fiche, the National Public and Transition Facility Co-financing, are reduced proportionally so as to maintain the agreed rate of co-financing. In case of Parallel Co-financing, where the final cost is lower than foreseen in the project fiche, it must be shown that the overall objectives of the project have been fully achieved 6. Implementation Arrangements

6.1 Implementing Agency

PAO: Tadeusz Kozek, Under-secretary of State at the Office of the Committee for European Integration, Al. Ujazdowskie 9, 00-918 Warszawa; phone +48 22 455 52 41, fax +48 22 455 52 43 CFCU: Andrzej Janicki, Foundation Co-operation Fund, CFCU Director, ul. Górnośląska 4a, 00-444 Warszawa, ph. +48 22 622 88 20, fax +48 22 622 75 65 The CFCU is responsible for handling tendering, contracting and payments of contracts on behalf of the OCCP.

6.2 Twinning

Contact person in the OCCP: Ms Magdalena Jaworska, Director, Department of Foreign Assistance, Budget and Administration, phone: +48 22 827 67 27, fax: +48 22 827 08 43, e-mail: mjaworska@uokik.gov.pl

6.3 Non-standard aspects

n.a.

Promoting consumer safety 15

6.4 Contracts

Contract 1 – Investments: 0.555 MEUR (TF) + 0.185 MEUR (joint co-financing) = 0.74 MEUR- gross value

Contract 2 – TA – specialised training for testing personnel: 0.30 MEUR (TF) + 0.03 MEUR (joint co-financing) = 0.33 MEUR- gross value

7. Implementation Schedule

7.1 Start of tendering/call for proposals 1st quarter 2006

7.2 Start of project activity 1st/2nd quarter 2006

7.3 Project Completion (last payment) 1st quarter 2008

8. Sustainability The purchased equipment will allow for permanent high quality performance of market controls. The laboratories, which will be equipped with new equipment, will have required technical capacities to fulfil legal requirements. All equipped laboratories together with already existing technical facilities will be able to realize all obligations resulting form relevant legal acts. 9. Conditionality and sequencing

Conditionality There are no conditionalities for project start and operation – assessment of TI existing laboratory equipment together with new legal obligations’ - is attached to the fiche – Annex 5.

Milestones and sequencing

• Signing of the Financing Memorandum.

• Preparation of relevant technical (investment) and tender (TA) documentation for contracts and start of tender procedures.

• Providing relevant training actions according to the beneficiaries specific needs

• Delivery of required equipment to TI laboratories.

• Approval of a project’s final report.

Promoting consumer safety 16

LOGFRAME MATRIX: Programme name and number: Contracting period expires IV quarter 2007

Disbursement period expires IV quarter 2008

Project: Promoting consumer safety

TOTAL BUDGET OF THE PROJECT EUR 1 070000

Transition Facility Budget EUR: 855 000

Overall objective Objectively Verifiable Indicators Sources of Verification • ensuring the same high level of consumer safety as

exists in the EU-15 General remark: please note that personnel participates in training sessions repeatedly personnel of Trade Inspection provided with further know-how on their particular competences referring to consumer safety. assuring by the end of 2007 the same level of performed of analytical and consumer tests as in the EU-15

Interim evaluation report

OCCP internal statistics

Number of laboratory tests done by TI labs increased.

Project purpose Objectively Verifiable Indicators Sources of Verification Assumptions • reinforcement of consumer safety through further

strengthening of professional competencies of Trade Inspection individuals and ensuring appropriate laboratory technical facilities

min. 100 persons responsible for testing trained on specific laboratory analytical methods in the light of new regulations and consumer tests methodology. assuring by the end of 2007 the same technical facilities for performing of analytical and consumer tests as in EU-15 – deliveries of equipment done as listed in the project fiche (all equipment bought)

OCCP and TI internal statistics

Trainings’ attendance lists

Protocols of deliveries of purchased equipment

TI statistics on performed tests and analyses on newly purchased equipment.

Stable state of human resources (trained staff remains within structures of the Trade Inspection) Required laboratory analyses and tests done accordingly to the binding law.

Results/Outputs Objectively Verifiable Indicators Sources of Verification Assumptions Contract 1– Investments laboratory equipment for TI laboratories

purchased for max. 0,74 M€ by the end of Protocols of deliveries of purchased

Promoting consumer safety 17

• envisaged equipment purchased and delivered tlaboratories to reinforce testing capacity of TI laboratoriein the scope of new analytical methods.

Contract 2– TA – specialised training for testing personnel • min. 100 persons responsible for testing trained on

specific laboratory analytical methods in the light of new regulations and consumer tests methodology.

the programme testing personnel (in total: c.a. 100 persons) trained by the end of the project analytical and consumer tests know-how transferred – number of laboratories prepared for performing of comparative testing

equipment Media – information on TI effectiveness. OCCP and TI studies and analyses Trainings’ attendance lists Training evaluation questioners Media – information on TI effectiveness.

Required experts provided

Activities Objectively Verifiable Indicators Sources of Verification Assumptions Contract 1– Investments • Purchases and delivery of laboratory equipment for food and non-food TI laboratories for the max. total gross value of 0,74 M€

- Contract 2– TA – specialised training for testing personnel food related – 9 training sessions

- non-food related – 4 training sessions - comparative testing related – 20 training sessions

laboratory equipment for TI laboratories purchased for max. 0,74 M€ by the end of the programme TA : 33 training sessions conducted

Protocols of deliveries of purchased equipment

OCCP and TI studies and analyses Trainings’ attendance lists Training evaluation questioners

Necessary State financial resources accessible

Preconditions None

Promoting consumer safety 18

ANNEX 2-4 Implementation, contracting and disbursement schedules Date of drafting:

Planning period:11.2004 01.2006-2008

PLANNED

Budget Allocation Cost

Estimate in MEUR

I ‘06 II ‘06 III ‘06 IV ‘06 I ‘07 II ‘07 III ‘07 IV ‘07 I ‘08 II ‘08 III ‘08 I II III IV V VI VII VIII IX

Implementation schedule D DC IC I I I I I I Contracting schedule 0.555 0.855 0.855 Disbursement schedule 0.2 0.5 0.7 0.8 0.855 0.855 Legend: D= design of project; C= tendering and contracting; I= contract implementation and payment

Promoting consumer safety 19

ANNEX 5 Needs Assessment of Trade Inspection Laboratory Equipment

Trade Inspection Chief Inspectorate has in charge 10 laboratories:

6 laboratories control food adulteration, 3 laboratories control non-food safety (textile, toys, cosmetics and detergents), 1 laboratory – a newly formed in 2005 Laboratory of Instrumental Analysis in Lodz - is a multipurpose specialistic unit.

4 laboratories have accreditation (as indicated in the table below) and remaining ones are in process of accreditation. Equipment for non-food laboratories

Promoting consumer safety 20

Name of equipment (according to the

project fiche)

Place of delivery Actual (possessed) instrumental laboratory equipment

Regulation Parameters to be analyzed due to

Regulation

Actually analyzed parameters on possessed

equipment

Parameters to be analyzed on the new equipment

LC/MS (Liquid Chromatography with Mass Spectrometry)

Laboratory in Lodz (Instrumental Analysis) preparing to Accreditation

HPLC with 4 detectors (UV-Vis, FLC, EC, DAD); GC with FID and ECD detector GC with FID + ECD, NPD detectors

UV-Vis SpectrophotometeAAS with 4 modules /F, GF, HG, CV/, F-AAS GC-MS with EI (2003

OJ of April 2004, No. 81 item 744, OJ of 11 December 2003, No. 210, OJ of 2004, No. 73 item 656, OJ of 28 July 2004, No. 168, item 1762.

Aromatic amines, formaldehyde, phthalates, BTEX, PCB, PCT, PBB, PCP, nitrosamines, phenols, dioxines, vinyl compounds, phosphoroorganic compounds – beyond 600 organic and heteroorganic compounds

Aromatic amines, formaldehyde, phthalates, (and sterols, waxes, fatty acids as their methyl esters in olive oil)

Lab. does not have LC-MS. This equipment gives unique possibility for analysis of chloroorganic, phosphoroorganic and complex non-volatile molecules, is especially useful in elaboration of new methods and qualitative and quantitative analysis of mixtures of analytes e.g. Aroclors, PCBs.

CI (Chemical Ionization Module) for GC-MS

Laboratory in Lodz preparing to Accreditation (CI gives significantly bigger possibilities to do more analysis in wider scale) (CI gives a possibility of complex mixtures analysis)

HPLC with 4 detectors (UV-Vis, FLC, EC, DAD); GC with FID and ECD detector GC with FID + ECD, NPD detectors

UV-Vis SpectrophotometeAAS with 4 modules /F, GF, HG, CV/ (2004), F-AAS GC-MS with EI (2003)

OJ of 2004, No. 81 item 744, OJ of 11 December 2003, No. 210, OJ of 2004, No. 73 item 656, OJ of 28 July 2004, No. 168, item 1762.

Aromatic amines, formaldehyde, phthalates, BTEX, PCB, PCT, PBB, PCP.

Aromatic amines, formaldehyde,

Lab. does not have CI. It allows to analyze Phthalates, BTEX, as a supplement to do more analysis with wider scope and validation of methods.

FTIR (Furier Transformation Infrared Spectroscopy)

Laboratory in Lodz (give chance to do new analysis of textiles and toys)

HPLC with 4 detectors (UV-Vis, FLC, EC, DAD); GC with FID and ECD detector GC with FID + ECD, MPD detectors UV-Vis Spectrophotometer ASA with 4 modules, ASA GC/MS with EI

OJ of 2004, No. 81 item 744, OJ of 11 December 2003, No. 210,

Safety and labeling of textile, essential requirements for toys

- Lab. does not have FTIR. It allows to do adulteration of composition of textiles and precision recognition of kind of fiber

HPLC Guard column HPLC Filters set

For all laboratories to HPLC column protection and set system

Because of the continuous use the equipment wears out quickly and has to be replaced with a new one on a regular basis.

HPLC Column For standards analysis in all laboratories

GC Autosampler /

Promoting consumer safety 21

Equipment for food laboratories

Promoting consumer safety 22

Name of equipment Place of delivery Actual instrumental laboratory equipment

Regulation Parameters to analyzed due to Regulation

Actually analyzed parameters on our

equipment

Parameters to analysis on new equipment

LC/MS (Liquid Chromatography with Mass Spectrometry)

Accredited Laboratory in Olsztyn (actual instrumental equipment in laboratory does not give opportunities to analyze required parameters)

HPLC with 4 detectors (UV-Vis, RID, FLC, EC) with oven; GC with FID detector 2 UV-Vis Spectrophotometer

OJ of 2002 No. 58, item 563, OJ of 2001, No. 76 item 811 with amendments, (EEC) No 1898/87, (EC) No 577/97, (EC) No. 1493/1999, OJ of 2003, No.177 item 1735 with amendments,.

Determination of food adulteration: sweeteners and preservatives in food products, sugars in honey, sugars in fruit juices, colorants in milk products, colorants in wine, carcinogenic substances in spices (sudan I).

Determination of food adulteration: sweeteners and preservatives in food products, sugars in honey,

Lab. does not have LC-MS. It gives new possibilities to do analysis on new kind of adulteration in the nearest future: sugars in fruit juices, colorants in milk products, colorants in wine, carcinogenic substances in spices (sudan I). It is possible also to do similar analyses like now but with much better precision, sensitivity, and 100% of veracity in shorter time.

GC-MS (Gas Chromatography with Mass Spectrometry)

Accredited Laboratory in Kielce

2 HPLC with 4 detectors (UV-VIS, DAD, FLC, EC) GC with FID detector 2 UV-Vis Spectrophotometer AAS

OJ of 2002 No. 58, O J of 2001, No. 76 item 811 with amendments, OJ of 2003, No.177 item 1735 with amendments, (EWG) NR 2568/91, 76/621/EEC, 80/891/EEC

Alcoholic beverages, (methanol, fusel oil) Fats and oils adulterations (fatty acids, sterols) artificial flavours in wines and fruit juices (organic acids)

Alcoholic beverages, (methanol, fusel oil)

Lab. does not have GC-MS. Fats and oils adulterations (fatty acids, sterols) artificial flavors in wines and fruit juices (organic acids)

HPLC with DAD detector

Accredited Laboratory in Olsztyn (gives possibilities to do more analysis and to connect with UV-VIS detector reconnected from first HPLC)

HPLC with 4 detectors (UV-Vis, RID, FLC, EC) with oven; GC with FID detector 2 UV-Vis Spectrophotometer

OJ of 2002 No. 58, item 563, OJ of 2004 No. 94, item 933

Sweeteners, preservatives in food, colorants, flavors

Sweeteners, preservatives in food

Lab. has only one HPLC set without DAD detector. It allows to do more analysis and to do validation of methods, and initiate new one.

HPLC RID detector CLASS VP compatible HPLC oven CLASS VP compatible HPLC Column for sugar determination (NH2)

Accredited Laboratory in Kielce (do connect HPLC set with RID detector and oven and with column according to specialization)

2 HPLC with 4 detectors (UV-VIS, DAD, FLC, EC) GC with FID detector 2 UV-Vis Spectrophotometer ASA

OJ of 2003, No.177 item 1735 with amendments, OJ of 2003, No. 181 item 1773 with amendments

Sugars in honey to verification of honey authenticity, sugars in fruit juices

- Lab. does not have oven HPLC, sugar column, RID detector. Sugars in honey to verification of honey authenticity, sugars in fruit juices

HPLC pump CLASS VP compatible HPLC DAD detector CLASS VP compatible

Accredited Laboratory in Warsaw

HPLC with 2 detectors (UV-Vis, RID) and oven GC with FID UV-Vis Spectrophotometer

OJ of 2003, No.177 item 1735 with amendments, OJ of 2003, No. 181 item 1773 with amendments

Sugars in honey, Sugars in fruit juices

- Lab. does not have DAD detector, and have a one pump. Sugars in honey to verification of honey authenticity, sugars in fruit juices. This equipment gives possibilities to do independent HPLC set with RID detector and this will be a new

Promoting consumer safety 23