Food safety

The EU integrated approach to food safety aims to assure a high level of food safety, animal health, animal welfare and plant health within the EU through coherent farm-to-table measures and adequate monitoring, while ensuring the effective functioning of the internal market (http://europa.eu.int/comm/food/ intro_en.htm). Recent trends in global food production, processing, distribution and preparation are creating an increasing demand for food safety research in order to ensure a safer global food supply (http://www.who.int/foodsafety/en/). The implementation of this approach involves the development of legislative and other actions in order to (a) assure effective control systems and evaluate compliance with EU standards in the food safety and quality, animal health, animal welfare, animal nutrition and plant health sectors within the EU and in third countries in relation to their exports to the EU, (b) manage international relations with third countries and international organizations concerning food safety, animal health, animal welfare, animal nutrition and plant health and (c) manage relations with the European Food Safety Authority (EFSA) and ensure science-based risk management (http://europa.eu.int/comm/food/intro_en.htm).

2.1.1 HACCP

Regulation (EC) No 178 /2002 (entry into force 1/1/2005) has three main functions (a) Provides the basis for the assurance of a high level of protection of human health and consumers' interest in relation to food, taking into account the diversity in the supply of food, including traditional products, while ensuring the effective functioning of the internal market. It establishes common principles and responsibilities, the means to provide a strong science base, efficient organizational arrangements and procedures to underpin decision-making in matters of food and feed safety. (b) Lays down the general principles governing food and feed at Community and national level. It established the EFSA. (c) It shall apply to all stages of production, processing and distribution of food and feed. It shall not apply to primary production for private domestic use or to the domestic preparation, handling or storage of food for private domestic consumption. The food law shall aim at the prevention of (a) fraudulent or deceptive practices, (b) the adulteration of food and (c) any other practices which may mislead the consumer.

Regulation (EC) No 852/2004 (entry into force 1/1/2006) lays down general rules for food business operators on the hygiene of foodstuffs, taking particular account of the following principles: (a) primary responsibility for food safety rests with the food business operator, (b) it is necessary to ensure food safety throughout the food chain, starting with primary production, (c) it is important, for food that cannot be stored safely at ambient temperatures, particularly frozen food, to maintain the cold chain, (d) general implementation of procedures based on the HACCP principles, together with the application of good hygiene practice, should reinforce food business operators' responsibility, (e) guides to good practice are a valuable instrument to aid food with food hygiene rules and with the application of the HACCP principles, (f) it is necessary to establish microbiological criteria and temperature control requirements based on a scientific risk assessment and (g) it is necessary to ensure that imported foods are of at least the same hygiene standard as food produced in the Community, or are of an equivalent standard.

Another Regulation (EC) No 853/2004 (entry into force 1/6/2006) has no application in relation to (a) primary production for private domestic use, (b) the domestic preparation, handling or storage of food for private domestic consumption, (c) the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying to the final consumer, (d) the direct supply, by the producer, of small quantities of meat from poultry and lagomorphs slaughtered on the farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer as fresh meat and (e) hunters who supply small quantities of wild game or wild game meat directly to the final consumer or to local retail establishments directly supplying the final consumer.

According to Regulation (EC) No 854/2004 (entry into force 1/1/2006) audits of good hygiene practices shall verify that food business operators apply procedures continuously and properly concerning at least (a) checks on food-chain information, (b) the design and maintenance of premises and equipment, (c) pre-operational, operational and post-operational hygiene, (d) personal hygiene, (e) training in hygiene and in work procedures, (f) pest control, (g) water quality, (h) temperature control and (i) controls on food entering and leaving the establishment and any accompanying documentation.

Regulation (EC) No 882/2004 (entry into force 1/1/2006) lays down general rules for the performance of official controls to verify compliance with rules aiming at (a) preventing, eliminating or reducing to acceptable levels risks to humans and animals, either directly or through the environment and (b) guaranteeing fair practices in feed and food trade and protecting consumer interests, including feed and food labeling and other forms of consumer information.

A summary of the EU Regulations related to HACCP is given in Table 1. 2.1.2 Pesticide contamination

The pesticides have been regulated by three rather old Directives (76 /895/EEC, 86/362/EEC, 90/642/EEC), which appeared over a period of 13 years between 1977 and 1990.

Directive 76/895/EEC (entry into force 1/1/1977) concerned products intended either for human or, in exceptional cases, animal consumption. For the purposes of this Directive the term ''pesticide residues'' comprises the residual traces of pesticides, as well as any of the toxic breakdown or metabolized products listed, present in or on the products to which the Directive applies. Member States may not prohibit or impede the putting on the market within their territories of the products referred, on the ground that they contain pesticide residues if the quantity of these residues does not exceed the established MRLs. When a Member State considers that a MRL might endanger the health of humans or of animals other than harmful organisms, that Member State may temporarily reduce that level in its own territory. In that case it shall immediately notify the other Member States and the Commission of the measures taken with a statement of the reasons thereof.

The Directive 86/362/EEC (entry into force 7/8/1986) applies to the following crops: wheat, rye, barley, oats, maize, paddy rice, buckwheat, millet, grain sorghum, triticale and other cereals. The MRLs of pesticide residues exceeds 0.1 mg/kg and concerns bromomethane, carbon disulphide, carbon tetrachloride, hydrogen cyanide, cyanides expressed as hydrogen cyanide, hydrogen phosphide, phosphides expressed as hydrogen phosphide. The Directive claims that Member States (a) shall ensure that the products referred do not, from the time they are put into circulation, present a danger to human health as a result of the presence of pesticide residues, (b) may not prohibit or impede the putting into circulation within their territories of the products referred, on the ground that they contain pesticide residues, if the quantity of such residues does not exceed the MRLs, (c) shall prescribe that the products referred, may not contain, from the time they are put into circulation, levels of residues of pesticides greater than those specified and (d) shall take all necessary measures to ensure, at least by check sampling, compliance with the MRLs. There is no application to the products intended for (i) export to third countries, (ii) the manufacture of products other than foodstuffs and (iii) sowing.

The Directive 90/642/EEC (entry into force 14/12/1990) also applies to products intended for export to third countries. However, the maximum pesticide residue levels shall not apply in the case of products treated before

Table 1 Regulations (main points and comments) related to HACCP

Title

Main points

Comments

Regulation (EC) No 178/2002 (entry into force 1/1/2005) General principles and requirements of food law, establishment of the European Food Safety Authority and report of procedures in matters of food safety

Regulation (EC) No 852/2004 (entry into force 1/1/2006) Hygiene of foodstuffs

Regulation (EC) No 853/2004 (entry into force 1/6/2006) Specific hygiene rules for food of animal origin

General principles, principles of transparency, general obligations of food trade, general requirements of food law.

Need for independence, transparency, confidentiality and communication of the EFSA.

Rapid alert system, crisis management and emergencies.

Food business operators' obligations. National and Community guides for good hygiene practice.

Requirements of imports and exports.

Specific rules on the hygiene of food of animal origin for food business operators. Not applicable to food containing both products of plant origin and processed products of animal origin.

Regulation (EC) No 854/2004 (entry into force 1/1/2006) Specific rules for the organization of official controls on products of animal origin intended for human consumption

Regulation (EC) No 882/2004 (entry into force 1/1/2006) Official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules

Official controls in relation to community establishments, general principles of official controls and actions in the case of noncompliance.

Procedures concerning imports or products of animal origin and fishery products.

Official controls of Member States relatively general obligations, competent authorities, sampling and analysis, crisis management, official controls on the introduction on food and feed of third countries and financing of official controls.

Reference laboratories.

Repeals Directive EU

. 1999/313/EC from 1/1/2006

Source: Adapted from [1] with permission from Blackwell Publishing.

export where it can be satisfactorily proved that (a) the third world country of destination requires that particular treatment in order to prevent the introduction of harmful organisms into its territory or (b) the treatment is necessary in order to protect the products against harmful organisms during the transport to the third world country of destination and storage there. The Directive shall not apply to the products referred, where it can be established by appropriate evidence that they are intended for (a) the manufacture of products other than foodstuffs and animal feed or (b) sowing or planting. The products or the parts of them shall not contain, from the time they are put into circulation, pesticide residue levels higher than those specified. In the case of dried products for which maximum levels are not fixed, the maximum level applicable shall be that laid down in the list, taking into account the residue concentration caused by the drying process. Member States shall ensure, at least by checking samples, compliance with the MRLs. The competent authority or authorities of the Member States shall draw up forward programs laying down the nature and frequency of the inspections to be carried out.

All the Directives related to pesticide contamination are given in Table 2. 2.1.3 Radioactive contamination

Regulation (EC) No 3954/87 (entry into force 2/1/1988) laid down the procedure for determining the maximum permitted levels of radioactive contamination of foodstuffs and of feedingstuffs that may be placed on the market following a nuclear accident or any other case of radiological emergency which is likely to lead to or has led to significant radioactive contamination of foodstuffs and feedingstuffs. In the event of the Commission receiving official information on accidents or on any other case of radiological emergency, substantiating that the maximum permissible levels are likely to be reached or have been reached, it will immediately adopt, if the circumstances so require, a Regulation rendering applicable those maximum permissible levels.

In Regulation (EC) No 2219/89 (entry into force 25/7/1989) the conditions for exporting foodstuffs and feedingstuffs after a nuclear accident or any other radiological situation likely to lead to significant radioactive contamination of foodstuffs and feedstuffs are laid down. Foodstuffs and feedingstuffs in which the level of radioactive contamination exceeds the relevant maximum permitted levels may not be exported. The Member States shall carry out checks to ensure that the maximum permitted levels are observed.

Regulation (EC) No 737/90 (entry into force 1/4/1990) applies to milk and dairy products for which the maximum permitted level of radioactivity is 370 Bq/kg The accumulated maximum radioactive level in terms of Cs-134 and Cs-137 shall be 370 Bq/kg for milk and milk products and 600 Bq/kg for all other products concerned.

The titles, main points and comments of the EU Regulations about radioactive contamination are summarized in Table 3.

Table 2 Directives (main points and comments) focused on pesticide contamination

Title

Main points

Comments

Directive 76/895/EEC (entry into force 1/1/ 1977)

Setting of maximum residue levels of pesticides in fruit and vegetables

Directive 86/362/EEC (entry into force 7/8/ 1986)

Setting of maximum residue levels of pesticides in cereals

Applicable to products intended for human and animal nutrition. Not applicable to products exported to third countries. Formal sampling to inspect whether the maximum residue levels are kept.

Not applicable to products exported to third world countries, not for edible or drinkable products and for those intended for sowing or planting.

Products that contain pesticide residues that exceed the maximum

Amendments — Directive

. 80/428/EEC (entry into force 11/9/1980), 81/36/EEC (entry into force 26/2/1981), 82/528/EEC (entry into force 4/8/1982), 88/298/EEC (entry into force 20/5/ 1988), 89/186/EEC (entry into force 10/3/1989), 93/ 58/EEC (entry into force 12/7/1993), 96/32/EC (entry into force 18/6/1996), 97/41/EC (entry into force 1/8/ 1997), 1999/65/EC (entry into force 8/7/1999), 2000/ 24/EC (entry into force 4/5/2000), 2000/57/EC (entry into force 19/10/2000), 2002/66/EC (entry into force 9/8/2002), 2002/71/EC (entry into force 29/8/2002), 2002/ 79/EC (entry into force 4/11/2002), 2003/60/EC (entry into force 14/7/2003)

• Regulation (EEC) No 3768/85 (entry into force 1/1/ 1986) and No 807/2003 (entry into force 5/6/2003)

• Replacement, correction and amendment of articles.

Amendments — Directive

. 86/363/EEC (entry into force 7/8/1986), 88/298/EEC (entry into force 20/5/1988), 93/57/EEC (entry into force 8/7/1993), 94/29/EEC (entry into force 23/7/ 1994), 95/39/EC (entry into force 11/9/1995), 96/33/ EC (entry into force 18/6/1996), 97/41/EC (entry into force 1/8/1997), 97/71/EC (entry into force 18/12/ 1997), 98/82/EC (entry into force 1/11/1998), 1999/ 65/EC (entry into force 8/7/1999), 1999/71/EC (entry into force 1/8/1999), 2000/24/EC (entry into force

Table 2 (Continued)

Title Main points levels are prohibited from circulation. • Sampling to inspect whether the maximum residue levels are kept.

Directive 90/642/EEC (entry into force 14/12/ 1990)

Setting of maximum residue levels of pesticides in certain products of plant origin including fruit and vegetables

• Register of list of fruits and vegetables containing the MRLs and of list containing residues of pesticides and their maximum levels.

• Commission should be annualy informed for the MRLs.

4/5/2000), 2000/42/EC (entry into force 1/7/2000), 2000/48/EC (entry into force 23/8/2000), 2000/58/EC (entry into force 19/10/2000), 2000/81/EC (entry into force 11/1/2001), 2001/39/EC (entry into force 21/6/ 2001), 2001/48/EC (entry into force 4/7/2001), 2001/ 57/EC (entry into force 21/8/2001), 2002/76/EC (entry into force 27/9/2002), 2002/79/EC (entry into force 4/11/2002), 2002/97/EC (entry into force 7/1/ 2003), 2003/60/EC (entry into force 14/7/2003), 2003/ 62/EC (entry into force 22/6/2003)

. Regulation (EC) No 807/2003 (entry into force 5/6/ 2003)

• Filling, amendment and replacement of articles.

Amendments — Directive

. 93/58/EEC (entry into force 12/7/1993), 94/30/EC (entry into force 23/7/1994), 95/38/EC (entry into force 11/9/1995), 95/61EC (entry into force 18/6/ 1996), 97/41/EC (entry into force 1/8/1997), 97/71/ EC (entry into force 7/1/1998), 98/82/EC (entry into force 1/11/1998), 1999/65/EC (entry into force 8/7/ 1999), 1999/71/EC (entry into force 1/8/1999), 2000/ 24/EC (entry into force 4/5/2000), 2000/42/EC (entry

• Products that contain pesticide residues that exceed the maximum levels are prohibited from circulation.

Source: Adapted from [1] with permission from Blackwell Publishing.

into force 1/7/2000), 2000/48/EC (entry into force 23/ 8/2000), 2000/57/EC (entry into force 19/10/2000), 2000/58/EC (entry into force 19/10/2000), 2000/81/ EC (entry into force 11/1/2001), 2001/35/EC (entry into force 19/5/2001), 2001/39/EC (entry into force 21/6/2001), 2001/48/EC (entry into force 4/7/2001), 2001/57/EC (entry into force 21/8/2001), 2002/5/EC (entry into force 6/2/2002), 2002/23/EC (entry into force 27/3/2003), 2002/42/EC (entry into force 11/6/

2002), 2002/66/EC (entry into force 9/8/2002), 2002/ 71/EC (entry into force 29/8/2002), 2002/76/EC (entry into force 27/9/2002), 2002/79/EC (entry into force 4/11/2002), 2002/97/EC (entry into force 7/1/

2003), 2002/100/EC (entry into force 27/1/2003), 2003/60/EC (entry into force 14/7/2003), 2003/62/EC (entry into force 22/6/2003), 2003/69/EC (entry into force 22/7/2003)

• Regulation (EC) No 806/2003 (entry into force 5/6/ 2003)

• Amendment of the Directive relatively with the MRLs.

Table 3 Regulations (main points and comments) dealing with radioactive contamination

Title

Main points

Comments

Regulation (EC) No 3954/87 (entry into force 2/1/ 1988)

Determination of maximum permitted levels of radioactive contamination of foodstuffs and feedstuffs following a nuclear accident or any other case of radiological emergency

Regulation (EC) No 2219/89 (entry into force 25/7/

1989)

Special conditions for exporting foodstuffs and feedstuffs following a nuclear accident or any other case of radiological emergency

Regulation (EC) No 737/90 (entry into force 1/4/

1990)

Conditions governing imports of agricultural products originating in third countries following the accident at the Chernobyl nuclear power station

Maximum permitted levels of radioactive contamination of foodstuffs and feedstuffs in case of nuclear accident.

• Duration of each regulation exceeds up to three months.

• Any foodstuff or feedstuff that exceeds the maximum permitted levels is banned from the market disposal.

• Conditions for exporting foodstuffs and feedstuffs after a nuclear accident.

• Any foodstuff or feedstuff that exceeds the maximum permitted levels is banned for export.

• Application for products originating from third countries.

• Determination of maximum accumulated radioactivity of Cs134 and Cs137.

• Control measures in case of non-compliance.

Amendment

• Replacement of the Annex (entry into force 25/7/ 1989)

Amendment

• Replacement of articles (entry into force 24/3/ 2000)

Source: Adapted from [1] with permission from Blackwell Publishing.

2.1.4 Residues of veterinary medicinal products

According to Directive 96/22/EC (entry into force 23/5/1996) Member States shall prohibit (a) the placing on the market of stilvenes, stilbene derivatives, their salts and esters and thyrostatic substances for administering to animals of all species and (b) the placing on the market of beta-agonists for administering to animals, the flesh and products of which are intended for human consumption. They shall, also, prohibit (i) the administering to a farm or aquaculture animal of substances having a thyrostatic, androgenic or gestagenic action and of beta-agonists, (ii) the holding of animals on a farm, the placing on the market or slaughter for human consumption of farm animals or of aquaculture animals that contain the substances referred or in which the presence of such substances has been established, (iii) the placing on the market for human consumption of aquaculture animals to which substances have been administrated and of processed products derived from such animals, (iv) the placing on the market of specific animals and (v) the processing of specific kinds of meat. Member States may authorize (1) the administering to farm animals, for therapeutic purposes, of oestradiol 17a, testosterone and progesterone and derivatives, (2) the administering, for therapeutic purposes, of authorized veterinary medicinal products containing (i) allyl trenbolone, administered orally, or beta-agonists to equidae and pets, (ii) beta-agonists, in the form of an injection to induce tocolysis in cows when calving. The official checks are carried out by the competent national authorities without prior notice. Member States shall also prohibit the importation from third countries (a) farm or aquaculture animals to which products or substances referred have been administered by any means whatsoever or to which substances or products referred have been administered, unless those substances or products were administered in compliance with the provisions and requirements laid down and the withdrawal periods allowed in international recommendations have been observed and (b) meat or products obtained from animals the importation of which is prohibited.

In agreement with Directive 96/23/EC (entry into force 23/5/1996) substances having anabolic effect and unauthorized substances are (1) stilbenes, stilbene derivatives, and their salts and esters, (2) antithyroid agents, (3) steroids, (4) resorcylic acid lactones, including zeranol and beta-agonists. Moreover, veterinary drugs and contaminants such as (A) antibacterial substances, including sulfonamides, quinolones, (B) other veterinary drugs (anthelmintics, anticoccidials, carbamates and pyrethroids, sedatives, non-steroidal anti-inflammatory drugs, other pharmacologically active substances) and (C) other substances and environmental contaminants (organochlorine compounds, including PCBs, organophosphorus compounds, chemical elements, mycotoxins, dyes). The plan used to carry out the required inspections shall (a) provide for detection of groups of residues or substances according to type of animal, (b) specify in particular the measures for detection of the presence of the substances referred in the animals, in the drinking water of the animals and in all places where the animals are bred or kept and residues of the aforementioned substances in live animals, their excrement and body fluids and in animal tissues and products such as meat, milk, eggs and honey and (c) comply with the sampling rules and levels. Member States may have official random checks conducted (i) during the manufacture of the substances and during their handling, storage, transport, distribution and sale or acquisition, (ii) at any point in the animal feedingstuffs production and distribution chain and (iii) throughout the production chain of animals and raw materials of animal origin covered by this Directive. Where illegal treatment is established, the competent authority must ensure that the livestock is immediately placed under official control. Where there is evidence of residues of authorized substances or products of a level exceeding the maximum limit for residues, the competent authority shall carry out an investigation in the farm of origin or departure, as applicable, to determine why the above limit was exceeded. In the event of repeated infringements of MRLs when animals are placed on the market by a farmer or products are placed on the market by a farmer or a processing establishment, intensified checks on the animals and products from the farm and/or establishment in question must be carried out by the competent authorities for a period of at least six months, products or carcases being impounded pending the results of analysis of the samples.

Some representative points and comments of the Directives regarding residues of veterinary medical products are given in Table 4.

2.1.5 Contaminants

A rather recent Regulation (EC) No 466/2001 (entry into force 5/4/2002) covers several foods both of plant and animal origin (1) fresh spinach, preserved-deep frozen or frozen spinach, fresh lettuce regarding the level of nitrates, (2) roundnuts, nuts, dried fruit, cereals, milk regarding the level of aflatoxins, (3) milk, infant fomulae, meat of bovine animals, sheep, pig and poultry, edible offal of cattle, sheep, pig and poultry, muscle meat of fish, muscle meat of wedge sole, crustaceans, bivalve molluscs, cephalopods, cereals, vegetables, fruit, berries, fats and oils, fruit juices, wines, horsemeat, liver and kidney of cattle, sheep, pig and poultry, rice, soybeans regarding the amount of heavy metals (lead, cadmium, mercury). Member States may, where justified, authorize for a transitional period the placing on the market of fresh lettuces and fresh spinach, grown and intended for consumption in their territory, with nitrate levels higher than those set as maximum levels. Member States shall communicate to the Commission by June 30 of each year, the results of their monitoring and report on the measures taken and the progress made with regard to the application and improvement of codes of good agricultural practice to reduce nitrate levels in lettuce and spinach. This information shall also contain the data on which their codes of good agricultural practice are based.

The Regulation (EC) No 466/2001 has been replaced by the Regulation (EC) No 1881/2006. The latter regulation contains the community measures for the following contaminants: mycotoxins (aflatoxins, ochratoxin A, fusarium-toxins and patulin), metals (cadmium, lead, mercury and inorganic tin), dioxins and PCBs, PAHs, 3-MCPD and nitrates. The summary of this Regulation is given in Table 5.

2.1.6 Biological safety

Regulation (EC) No 999/2001 (entry into force 1/7/2001) has no application to (a) cosmetic or medicinal products or medical devices, or to their starting materials or intermediate products, (b) products which are not intended for use in human food, animal feed or fertilisers, or to their starting materials or intermediate products, (c) products of animal origin intended for exhibition, teaching, scientific research, special studies or analysis and (d) live animals used in or

Table 4 Directives (main points and comments) for residues of veterinary medical products

Title

Main points

Comments

Directive 96/22/EC (entry into force 23/5/1996) The prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists

Directive 96/23/EC (entry into force 23/5/1996) Measures to monitor certain substances and residues thereof in live animals and animal products

The placing on the market and the administering to farm animals of substances having a thyrostatic action or substances having an oestrogenic, androgenic or gestagenic action and of stilbenes and beta-agonists are prohibited. A certain number of these substances may be used for therapeutic purposes provided their use is controlled.

The monitoring substances are divided into two groups: substances having anabolic effect and unauthorized substances on the one hand, and veterinary drugs and contaminants on the other. Determination of the official control measures and of those taken in the event of infringement.

Repeals

• Directive EU 81/602/EEC from 1/7/1997

• Directive EU 88/146/EEC from 1/7/1997

• Directive EU 88/299/EEC from 1/7/1997

Repeals

• Directive EU 85/358/EEC from 1/7/1997

• Directive EU 86/469/EEC from 1/7/1997

• Directive EU 89/197/EEC from 1/7/1997

• Directive EU 91/664/EEC from 1/7/1997

Source: Adapted from [1] with permission from Blackwell Publishing.

intended for research. Each Member State shall carry out an annual program for monitoring BSE and scrapie. Member States shall inform the Commission of the emergence of a Transmissible Spongiform Encephalopathy (TSE) other than BSE. All official investigations and laboratory examinations shall be recorded.

The purpose of Regulation (EC) No 2160/2003 (entry into force 12/12/2003) is to ensure that proper and effective measures are taken to detect and to control Salmonella and other zoonotic agents at all relevant stages of production, processing and distribution, particularly at the level of primary production, including in feed, in order to reduce their prevalence and the risk they pose to public health. This Regulation shall cover (a) the adoption of targets for the reduction of the prevalence of specified zoonoses in animal populations,

Table 5 Regulation (main points and comments) related to contaminants

Title

Main points

Comments

Regulation (EC) No

• Setting of maximum

Amendments

466/2001 (entry into

levels for certain

• Regulation (EC)

force 5/4/2002)

contaminants in

No 1881/2006

Setting maximum levels

foodstuffs.

(entry into force

for certain

10/1/2007)

contaminants in

• Replacement of the

foodstuffs

Annex

Source: Adapted from [1] with permission from Blackwell Publishing.

Source: Adapted from [1] with permission from Blackwell Publishing.

(b) the approval of specific control programs established by Member States and food and feed business operators, (c) the adoption of specific rules concerning certain control methods applied in the reduction of the prevalence of zoonoses and zoonotic agents and (d) the adoption of rules concerning intra-Community trade and imports from third countries of certain animals and products thereof. Some points of the EU legislation focused on biological safety are stated in Table 6.

2.1.7 Packaging

Packaging per se and the food-packaging interactions were considered an issue of crucial importance because several problems, ranging from poisoning to death, occurred over the years. Most of these problems were either due to usage of inappropriate packaging materials or migration (of monomers, oligomers, catalysts, colorants etc.). A great number of Directives (more than ten) were published to fill this gap on packaging issues.

Directive 75/106/EEC (entry into force 19 /6/1976) relates to prepackages containing the liquid products measured by volume for the purpose of sale in individual quantities of between 5 mL and 10 L inclusive. This Directive shall not apply to prepackages containing the products which are vatted, bottled and labeled in volumes not exceeding 0.25 L and are intended for professional use and which are intended either for consumption on board aircraft, ships and trains or for sale in duty-free shops. The prepackages may be marked with the EEC mark. The actual contents of prepackages may be measured directly by means of weighing instruments or volumetric instruments or, in the case of liquids, indirectly, by weighing the prepacked product and measuring its density. Irrespective of the method used, the error made in measuring the actual contents of a prepackage shall not exceed one-fifth of the tolerable negative error for the nominal quantity in the prepackage. The procedure for measuring the actual contents of a prepackage may be the subject of domestic regulations in each Member State. The checking of prepackages shall be carried out by sampling and shall be in two parts a check covering the actual contents of each prepackage in the sample and another check on the average of the actual contents of the prepackages in the sample. A batch of prepackages shall be considered

Table 6 Regulations (main points) with regard to biological safety

Title

Main points

Regulation (EC) No 999/2001 (entry into force 1/7/2001) Rules for the prevention, control and eradication of certain TSEs.

Regulation (EC) No 2160/2003 (entry into force 12/12/2003) The control of Salmonella and other specified food-borne zoonotic agents.

Rules for the prevention, control and eradication of TSEs in animals. Application to the production and placing on the market of live animals and products of animal origin and in certain specific cases to exports thereof. Member States shall carry out an annual program for monitoring BSE and scrapie.

Measures to detect and to control Salmonella and other zoonotic agents. Application to production, processing and distribution.

Designation of a competent authority for each Member State and arrangement of responsibilities.

Source: Adapted from [1] with permission from Blackwell Publishing.

acceptable if the results of both these checks satisfy the acceptance criteria. For each of these checks, there are two sampling plans one for non-destructive testing, i.e., testing which does not involve opening the package and the other for destructive testing, i.e., testing which involves opening or destroying the package.

Directive 76/211/EEC (entry into force 23/1/1976) relates to prepackages containing products relating to the making-up by volume of certain prepackaged liquids, and intended for sale in constant unit nominal quantities which are equal to values predetermined by the packer, expressed in units of weight or volume, not less than 5g or 5mL and not more than 10 kg or 10 L. A prepackage within the meaning of this Directive is the combination of a product and the individual package in which it is prepacked. A product is prepacked when it is placed in a package of whatever nature without the purchaser being present and the quantity of product contained in the package has a predetermined value and cannot be altered without the package either being opened or undergoing a perceptible modification. All prepackages must bear an indication of the weight or volume of the product, known as ''nominal weight'' or ''nominal volume'', which they are required to contain. Prepackages containing liquid products shall be marked with their nominal volume and prepackages containing other products shall be marked with their nominal weight, except in the case of trade practice or national regulations which provide otherwise and which are identical in all Member States, or in the case of contrary Community rules. If trade practice or national regulations are not the same in all Member States for a category of products or for a type of prepackage, those prepackages must at least show the metrological information corresponding to the trade practice or national regulations prevailing in the country of destination.

In Directive 78/142/EEC (entry into force 1/2/1978), the presence of vinyl chloride monomer in, and possible migration from, materials and articles prepared with vinyl chloride polymers or copolymers, hereinafter called ''materials and articles'', which in their finished state are intended to come into contact with foodstuffs, or which are in contact with foodstuffs and are intended for that purpose is analysed. Materials and articles must not pass on to foodstuffs which are in or have been brought into contact with such materials and articles with any vinyl chloride detectable by the method which complies with the criteria laid down in this Directive. Maximum vinyl chloride monomer level in materials and articles laid down 1 mg/kg in the final product. Criteria applicable to the method of determining the level of vinyl chloride in materials and articles and of determining vinyl chloride released by materials and articles (1) the level of vinyl chloride in materials and articles and the level of vinyl chloride released by materials and articles to foodstuffs are determined by means of gas-phase chromatography using the ''headspace'' method, (2) for the purposes of determining vinyl chloride released by materials and articles to foodstuffs, the detection limit shall be 0.701 mg/kg and (3) vinyl chloride released by materials and articles to foodstuffs is in principle determined in the foodstuffs. When the determination in certain foodstuffs is shown to be impossible for technical reasons, Member States may permit determination by simulants for these particular foodstuffs.

According to Directive 80/232/EEC (entry into force 17/3/1980) the products shall be divided into three groups (a) products sold by weight or by volume,

(b) products sold by weight or by volume and put up in the rigid containers and

(c) products put up in aerosol form. Food products in which the Directive shall apply are butter, margarine, emulsified or non-animal and vegetable fats (low fat spreads), fresh cheeses except ''petits suisses'' and other cheeses put up in the same way, table and cooking salt, impalpable sugars, red or brown sugars, candy sugars, cereal products (excluding foods for infants), dried vegetables, dried fruits, ground or unground roasted coffee, chicory and coffee substitutes, frozen products (fruit and vegetables and pre-cooked potatoes for chips, fish fillets and portions, breaded or not breaded, fish fingers).

In Directive 82/711/EEC (entry into force 4/11/1982) reference is made to plastic materials and articles, that is to say to materials and articles and parts thereof (A) consisting exclusively of plastics or (B) composed of two or more layers of materials, each consisting exclusively of plastics, which are bound together by adhesives or by any other means, which, in the finished product state, are intended to come into contact or are brought into contact with foodstuffs and are intended for that purpose. For the purposes of this Directive, plastics shall mean the organic macromolecular compounds obtained by polymerization, polycondensation, polyaddition or any other similar process from molecules with a lower molecular weight or by chemical alteration of natural macromolecules. Silicones and other similar macromolecular compounds shall also be regarded as plastics. Other substances or matter may be added to such macromolecular compounds. However, the following shall not be regarded as plastics: (i) varnished or unvarnished regenerated cellulose film, (ii) elastomers and natural and synthetic rubber, (iii) paper and paperboard, whether modified or not by the addition of plastics, (iv) surface coatings obtained from paraffin waxes, including synthetic paraffin waxes, and/or micro-crystalline waxes and mixtures of the waxes listed in the first indent with each other and/or with plastics. The tests are to be carried out using all the simulants mentioned below, taking a fresh sample of the plastic material or article for each simulant: distilled water or water of equivalent quality, 3% acetic acid (w/v) in aqueous solution, 15% ethanol (v/v) in aqueous solution, rectified olive oil, if for technical reasons connected with the method of analysis it is necessary to use different simulants, olive oil must be replaced by a mixture of synthetic triglycerides or by sunflower oil.

Directive 93/10/EEC (entry into force /1/1994) claimed that it shall apply to regenerated cellulose film which either (a) constitutes a finished product in itself or (b) forms part of a finished product containing other materials, and which is intended to come into contact with foodstuffs or which, by virtue of its purpose, does come into such contact. This Directive does not apply to (a) regenerated cellulose film which, on the side intended to come into contact with foodstuffs or which, by virtue of its purpose does come into such contact, has a coating exceeding 50 mg/dm2, (b) synthetic casings of regenerated cellulose. Printed surfaces of regenerated cellulose film shall not come into contact with the foodstuffs. Member States shall (i) permit, as from 1/1/1994, the trade in and use of regenerated cellulose film which is intended to come into contact with foodstuffs complying with this Directive, (ii) prohibit, as from 1/1/1994, the trade in and use of regenerated cellulose film which is intended to come into contact with foodstuffs not complying with this Directive and (iii) prohibit, as from 1/1/1995, the trade in and use of regenerated cellulose film which is intended to come into contact with foodstuffs.

The aim of Directive 94/62/EC (entry into force 31/12/1994) was to harmonize national measures concerning the management of packaging and packaging waste in order, on the one hand, to prevent any impact thereof on the environment of all Member States as well as of third countries or to reduce such impact, thus providing a high level of environmental protection, and, on the other hand, to ensure the functioning of the internal market and to avoid obstacles to trade and distortion and restriction of competition within the Community. To this end this Directive lays down measures aimed, as a first priority, at preventing the production of packaging waste and, as additional fundamental principles, at reusing packaging, at recycling and other forms of recovering packaging waste and, hence, at reducing the final disposal of such waste. This Directive covers all packaging placed on the market in the Community and all packaging waste, whether it is used or released at industrial, commercial, office, shop, service, household or any other level, regardless of the material used. This Directive shall apply without prejudice to existing quality requirements for packaging such as those regarding safety, the protection of health and the hygiene of the packed products or to existing transport requirements. For the purposes of this Directive packaging, shall mean all products made of any materials of any nature to be used for the containment, protection, handling, delivery and presentation of goods, from raw materials to processed goods, from the producer to the user or the consumer. Packaging consists only of (a) sales packaging or primary packaging, (b) grouped packaging or secondary packaging and (c) transport packaging or tertiary packaging. Member States shall take the necessary measures to attain the following targets covering the whole of their territory: (a) no later than five years from the date by which this Directive must be implemented in national law, between 50% as a minimum and 65% as a maximum by weight of the packaging waste will be recovered, (b) within this general target, and with the same time limit, between 25% as a minimum and 45% as a maximum by weight of the totality of packaging materials contained in packaging waste will be recycled with a minimum of 15% by weight for each packaging material and (c) no later than 10 years from the date by which this Directive must be implemented in national law, a percentage of packaging waste will be recovered and recycled. The Commission shall promote, in particular, the preparation of European standards relating to (i) criteria and methodologies for life-cycle analysis of packaging, (ii) the methods for measuring and verifying the presence of heavy metals and other dangerous substances in the packaging and their release into the environment from packaging and packaging waste, (iii) criteria for a minimum content of recycled material in packaging for appropriate types of packaging, (iv) criteria for recycling methods, (v) criteria for composting methods and produced compost and (vi) criteria for the marking of packaging. Member States shall ensure that the sum of concentration levels of lead, cadmium, mercury and hexavalent chromium present in packaging or packaging components shall not exceed the following: (A) 600 ppm by weight two years after the date 30/6/1996, (B) 250 ppm by weight three years after the date 30/6/1996 and (C) 100 ppm by weight five years after the date 30/6/1996. Information for users of packaging Member States shall take measures, within two years of the date referred to this Directive, to ensure that users of packaging, including in particular consumers, obtain the necessary information about (i) the return, collection and recovery systems available to them, (ii) their role in contributing to reuse, recovery and recycling of packaging and packaging waste, (iii) the meaning of markings on packaging existing on the market and (iv) the appropriate elements of the management plans for packaging and packaging waste.

Directive 97/23/EC (entry into force 29/7/1997) applies to the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure greater than 0.5 bar. Member States shall not, on grounds of the hazards due to pressure, prohibit, restrict or impede the placing on the market or putting into service under the conditions specified by the manufacturer of pressure equipment or assemblies which comply with this Directive and bear the CE marking indicating that they have undergone conformity assessment. Pressure equipment and assemblies the conformity of which has been assessed by a user inspectorate shall not bear the CE marking. The pressure equipment and assemblies referred to may be used only in establishments operated by the group of which the inspectorate is part. The group shall apply a common safety policy as regards the technical specifications for the design, manufacture, inspection, maintenance and use of pressure equipment and assemblies. The user inspectorates shall act exclusively for the group of which they are part. The CE marking shall be affixed in a visible, easily legible and indelible fashion to each item of pressure equipment which is complete or is in a state permitting final assessment. It is not necessary for the CE marking to be affixed to each individual item of pressure equipment making up an assembly. Individual items of pressure equipment already bearing the CE marking when incorporated into the assembly shall continue to bear that marking. Where the pressure equipment or assembly is subject to other Directives covering other aspects which provide for the affixing of the CE marking, the latter shall indicate that the pressure equipment or assembly in question is also presumed to conform to the provisions of this Directive. Pressure equipment must be designed, manufactured and checked, and if applicable equipped and installed, in such a way as to ensure its safety when put into service in accordance with the manufacturer's instructions, or in reasonably foreseeable conditions. In choosing the most appropriate solutions, the manufacturer must apply the principles set out below in the following order: (i) eliminate or reduce hazards as far as is reasonably practicable, (ii) apply appropriate protection measures against hazards which cannot be eliminated and (iii) where appropriate, inform users of residual hazards and indicate whether it is necessary to take appropriate special measures to reduce the risks at the time of installation and/or use. Where the potential for misuse is known or can be clearly foreseen, the pressure equipment must be designed to prevent danger from such misuse or, if that is not possible, adequate warning be given that the pressure equipment must not be used in that way. The method of operation specified for pressure equipment must be such as to preclude any reasonably foreseeable risk in operation of the equipment. Particular attention must be paid, where appropriate, to (a) closures and openings, (b) dangerous discharge of pressure relief blow-off, (c) devices to prevent physical access while pressure or a vacuum exists, (d) surface temperature taking into consideration the intended use and (e) decomposition of unstable fluids. The manufacturer must ensure the competent execution of the provisions set out at the design stage by applying the appropriate techniques and relevant procedures, especially with a view to the aspects set out below. Preparation of the component parts (e.g., forming and chamfering) must not give rise to defects or cracks or changes in the mechanical characteristics likely to be detrimental to the safety of the pressure equipment. Permanent joints and adjacent zones must be free of any surface or internal defects detrimental to the safety of the equipment. The properties of permanent joints must meet the minimum properties specified for the materials to be joined unless other relevant property values are specifically taken into account in the design calculations. Where there is a risk that the manufacturing process will change the material properties to an extent which would impair the safety of the pressure equipment, suitable heat treatment must be applied at the appropriate stage of manufacture. Suitable procedures must be established and maintained for identifying the material making up the components of the equipment which contribute to pressure resistance by suitable means from receipt, through production, up to the final test of the manufactured pressure equipment.

Directive 2002/16/EC (entry into force 15/3/2002) is applicable to materials and articles which, in the finished product state, are intended to come into contact or are brought into contact with foodstuffs and are intended for that purpose and which are manufactured with or contain one or more of the following substances: (a) 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (hereinafter BADGE) and some of its derivatives, (b) bis(hydroxyphenyl)-methane bis(2,3-epoxypropyl)ethers (hereinafter BFDGE) and some of their derivatives and (c) other novolac glycidyl ethers (hereinafter NOGE) and some of their derivatives. For the purposes of this Directive, materials and articles are (i) materials and articles made of any type of plastics, (ii) materials and articles covered by surface coatings and (iii) adhesives. This Directive shall not apply to containers or storage tanks having a capacity greater than 10,000 L or to pipelines belonging to or connected with them, covered by special coatings called ''heavy-duty coatings''. The sum of the migration levels of the following substances: (a) BADGE, (b) BADGE • H2O, (c) BADGE • HCl, (d) BADGE • 2HCl, (e) BADGE • H2O • HCl shall not exceed the following limits: (i) 1 mg/kg in foodstuffs or in food simulants (analytical tolerance excluded) or (ii) 1 mg/6 dm2 in accordance with this Directive.

According to proposal of Regulations C0M(2003)0689 and C0D(2003)0272, the target of this Regulation is to ensure the effective functioning of the internal market in relation to materials and articles intended to come into contact with foodstuffs, while providing the basis for securing a high level of protection of human health and the interests of consumers. This Regulation shall apply to materials and articles, including active and intelligent food contact materials and articles, which in their finished state (a) are intended to be brought into contact with food or (b) are already brought into contact with food and are intended for that purpose or (c) can reasonably be expected to be brought into contact with foods or to transfer their constituents to food. This Regulation shall not apply to (a) materials and articles which were manufactured and placed on the market before 1/1/1980 and which are supplied as antiques, (b) covering or coating products, such as the products covering cheese rinds, prepared meat products or fruits, which form part of food and may be consumed together with this food and (c) fixed public or private water supply equipment. Active food contact materials and articles means materials and articles that are intended to extend the shelf-life or to maintain or improve the condition of packaged food. They are designed to deliberately incorporate components that would release or absorb substances into or from the packaged food or the environment surrounding the food. Intelligent food contact materials and articles means materials and articles which monitor the condition of packaged food or the environment surrounding the food. Materials and articles shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could (i) endanger human health or (ii) bring about an unacceptable change in the composition of the food or a deterioration in the organoleptic characteristics thereof. For the groups of materials and articles and where appropriate, combinations of those materials and articles, specific measures may be adopted in accordance with the Directive. Those specific measures may include (a) a list of the substances and the use of which is authorized to the exclusion of all others, (b) purity standards for substances, (c) special conditions of use for substances and/or the materials and articles in which they are used, (d) specific limits on the migration of certain constituents or groups of constituents into or onto food, taking due account of other possible sources of exposure to those constituents,

(e) an overall limit on the migration of constituents into or onto food,

(f) provisions aimed at protecting human health against hazards arising from oral contact with materials and articles, (g) other rules to ensure compliance with this Directive, (h) basic rules for checking compliance with this Directive, (i) rules concerning the collection of samples and the methods of analysis to check compliance with this Directive, (j) additional provisions for ensuring traceability of materials and articles and (k) provisions requiring that the Commission establishes and maintains a publicly available Community Register (''Register'') of authorized substances, materials or articles. The applicant may, in accordance with the procedure laid down in this Directive, apply for a modification of the existing authorization. The application shall be accompanied by the following: (a) a reference to the original application, (b) a technical dossier containing the new information according to the guidelines, (c) a new complete summary of the technical dossier in a standardised form. The traceability of the materials and articles shall be established at all stages of manufacture, processing and distribution. Business operators shall have in place systems and procedures to allow the identification of the businesses from which and to which the materials or articles and, where appropriate, substances or products used in their manufacture have been supplied. That information shall be made available to the competent authorities on demand. The materials and articles, which are placed on the market in the Community, shall be adequately labeled or identified to facilitate their traceability through relevant documentation or information. List of groups of materials and articles which may be covered by specific measures are active and intelligent materials and articles, adhesives, ceramics, cork, elastomers and rubbers, glass, ion-exchange resins, metals and alloys, paper and board, plastics, printing inks, regenerated cellulose, textiles, varnishes and coatings, waxes and wood. All the EU Directives/Regulations dealing with packaging are given in Table 7.

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