Category Archives: Contamination and Environmental Factors

The European Union takes care to prevent and limit any contamination of foodstuffs by certain undesirable substances or as a result of human activities. The EU thus regulates the use of certain specific chemical substances, such as those used in farming or in certain production or food processing techniques. Measures are also taken to limit contamination from the pollution of water or air, or from exposure to radioactivity. The risks of contamination by genetically modified organisms and by food packaging are also monitored.

Contaminants in food

Contaminants in food

Outline of the Community (European Union) legislation about Contaminants in food

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Contaminants in food

Document or Iniciative

Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food [See amending act(s)].

Summary

Regulation (EEC) No 315/93 prohibits the marketing of foodstuffs containing an unacceptable amount of residual substances. These substances, called contaminants, are present in food as a result of treatment after production or through environmental contamination. They are likely to pose a hazard to public health. For this reason, the European Union regulates the toxicologically acceptable levels of contaminants and keeps them at the lowest possible levels.

This Regulation does not apply to contaminants which are the subject of more specific rules, or to extraneous matter, such as insect fragments, animal hair, etc.

A Member State may take restrictive measures by reference to the present Regulation if it suspects that the presence of a contaminant poses a hazard to public health. If so, it must inform the other Member States and the Commission immediately and give reasons for its decision. The Commission shall examine the reasons given by the Member State as soon as possible and take appropriate measures after having consulted the Standing Committee on the Food Chain and Animal Health. This Committee assists the Commission on all matters which concern contaminants, including the establishment of authorised maximum tolerances.

Member States may not prohibit trade in foods which comply with this Regulation.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EEC) No 315/93

1.3.1993

OJ L 37 of 13.2.1993

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1882/2003

20.11.2003

OJ L 284 of 31.10.2003

Regulation (EC) No 596/2009

7.8.2009

OJ L 188 of 18.7.2009

The successive amendments and corrections to Regulation (EEC) No 315/93 have been incorporated into the original text. This consolidated versionis of documentary value only.

Related Acts

Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs [Official Journal L 364 of 20.12.2006].
This Regulation lays down the maximum admissible content of nitrates, mycotoxins, metals, dioxins, polycyclic aromatic hydrocarbons, etc. in food.
See consolidated version

Maximum levels for certain contaminants

Maximum levels for certain contaminants

Outline of the Community (European Union) legislation about Maximum levels for certain contaminants

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Maximum levels for certain contaminants

Document or Iniciative

Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs [See amending act(s)].

Summary

This Regulation lays down the maximum quantities for certain contaminants: nitrates, mycotoxins * (aflatoxins, ochratoxin A, patulin and Fusarium toxins), heavy metals (lead, cadmium, mercury), monochloro-propane-1, 2- diol (3-MCPD), dioxins and dioxin-type PCBs, polycyclic aromatic hydrocarbons (PAH) and inorganic tin.

Food with levels of contaminants higher than those specified in the Annex to the Regulation may not be placed on the market.

These maximum limits cover the edible part of food and also apply to compound or processed, dried or diluted foods, whereby a concentration or dilution factor may be applied or by taking into account the relative proportions of the ingredients in the compound product.

The Regulation also lays down the lowest maximum levels for contaminants which are reasonably achievable with good manufacturing practices or good agricultural practices (ALARA, As Low As Reasonably Achievable).

CONTAMINANTS

Nitrates

They are mainly present in vegetables (spinach, lettuce).

Some Member States are temporarily authorised to place on their national markets spinach and lettuce with levels of nitrates higher than those laid down in the Annex to the Regulation as long as these quantities remain acceptable in terms of public health. This transitional period is intended to allow the Member States affected to take the necessary steps to be able to comply with Community standards as quickly as possible.

The maximum levels of nitrates in vegetables are laid down according to the season.

The acceptable daily intake (ADI) laid down by the Scientific Committee on Food (SCF) is 3.65 mg/kg body weight.

Aflatoxins

These are genotoxic carcinogenic substances which develop at high temperatures and levels of humidity.

Sorting methods or other physical treatments enable the level of aflatoxins to be reduced for certain products such as groundnuts, nuts, dried fruit, maize and rice.

This Regulation permits higher levels of aflatoxins in these products if they are not intended for direct human consumption or use as an ingredient in food.

Ochratoxin A (OTA)

Ochratoxin A (OTA) is a mycotoxin produced by several fungi (penicillium and aspergillus species) with carcinogenic, nephrotoxic, teratogenic, immunotoxic and possibly neurotoxic properties. It has also been associated with nephropathy in humans.

It is naturally present in many crop products throughout the world, such as cereals, coffee beans, cocoa and dried fruit.

This Regulation lays down the maximum levels of the said substance for cereals, cereal products, raisins, roasted coffee, wine, grape juice, spices, liquorice and food for children.

The tolerable weekly intake (TWI) of ochratoxin A is 120 ng/kg body weight.

Patulin

Patulin is a mycotoxin produced by several types of fungus. It may be found in fruit juice, especially apple juice.

The provisional maximum tolerable daily intake for this substance is 0.4 ?g/kg body weight (bw).

Fusarium toxins

A variety of Fusarium fungi produces a number of mycotoxins * of the trichothecenes class, such as deoxynivalenol (DON), nivalenol (NIV), T-2 toxin, HT-2 toxin and some other toxins (zearalenone and fumonisins). Fusarium fungi are commonly found on cereals grown in the temperate regions of America, Europe and Asia. Several of the Fusarium fungi are capable, to a variable degree, of producing two or more of these toxins.

The SCF has adopted six opinions laying down a tolerable daily intake (TDI for these toxins. It established a TDI for deoxynivalenol of 1 ?g/kg body weight, a provisional TDI of 0.2 ?g/kg body weight for zearalenone, a TDI of 2 ?g/kg body weight for fumonisins, a provisional TDI of 0.7 ?g/kg body weight for nivalenol, a combined provisional TDI of 0.06 ?g/kg body weight for T-2 and HT-2 toxins and an opinion on trichothecenes as a group.

On the basis of these scientific opinions and the assessment of the dietary intake, this Regulation lays down the maximum levels for deoxynivalenol, zearalenone and fumonisins.

The Regulation states that the presence of T-2 and TH-2 may also be a public health concern. The Commission will therefore develop a reliable and sensitive method for detecting these toxins and continue to study the causes of their appearance in cereals and in particular in oats.

Lead

Lead absorption may constitute a serious risk to public health, since it may slow cognitive development, impair intellectual performance in children and increase blood pressure and cardiovascular diseases in adults.

The maximum level of lead in fish has been changed to 0.30 mg/kg fresh weight by the EU, taking account of the discussions within the .

Cadmium

Cadmium absorption also constitutes a risk to humans, since it may induce kidney dysfunction, skeletal damage and reproductive disorders.

Mercury

This substance may induce alterations in the normal development of the brain of infants and at higher levels may induce neurological changes in adults. It mostly contaminates fish and fishery products.

Methylmercury is the chemical form of mercury which is the greatest source of concern.

3-monochloropropane-1,2-diol (3-MCPD)

This carcinogenic substance is formed under certain conditions during food processing. In particular, it may be produced during manufacture of the food ingredient “hydrolysed vegetable protein” by the acid hydrolysis method.

By adjusting the production processes, the amount of 3-MCPD in the above-mentioned product has been reduced significantly. The main sources of exposures through food are soya sauce and soya sauce-based products.

The TDI is 2 µg/kg body weight.

Dioxins and dioxin-type polychlorinated biphenyls (PCBs)

Dioxins are chemicals resulting from certain natural phenomena (volcanism, forest fires) or industrial processes (manufacturing of pesticides, metals or paint, paper bleaching, incineration, etc.).

PCBs are chemicals which are widespread and found in, inter alia, building materials, lubricants, waterproofing agents and paints. Both types of substance may cause serious health problems, including cancer, immune and nervous system disorders, liver damage and sterility.

The TWI is 14 pg World Health Organisation toxic equivalent (WHO-TEQ)/kg body weight.

Polycyclic aromatic hydrocarbons (PAHs)

Some of these are genotoxic carcinogens. Contamination by PAHs may occur during smoking, heating and drying of food or through environmental pollution, especially in fish.

In order to protect public health, maximum levels are necessary for benzo(a)pyrene in certain foods containing fats and oils and in foods where smoking or drying processes might cause high levels of contamination. Maximum levels are also necessary in foods where environmental pollution may cause high levels of contamination, in particular in fish and fishery products, resulting, for example, from oil spills caused by shipping.

Inorganic tin

This type of tin may be found in tinned food and canned drinks. It may provoke gastric irritation in certain susceptible groups of the population.

For tinned foods other than beverages, the maximum level was laid down at 200 mg/kg. For canned beverages, the maximum level was laid down at 100 mg/kg.

BAN ON MIXING

Foods which comply with the maximum levels of contaminants may not be mixed with other foods which exceed these limits. By the same token, foods which must be sorted or subjected to other physical treatments to reduce the level of contamination may not be mixed with foods which comply with the maximum levels for human consumption.

SPECIFIC RULES ON LABELLING

Labelling on groundnuts, other oilseeds, nuts, dried fruit, rice and maize put on the market as foods which have to be subjected to sorting or other physical treatment before human consumption must include the wording: “product must be subjected to sorting or other physical treatments to reduce aflatoxin contamination before human consumption or use as an ingredient in foodstuffs”.

In addition, labelling on groundnuts, other oilseeds, products derived from oilseeds and cereals must indicate the use and lot identification code. If it is not clearly specified that they are not intended for human consumption, the maximum levels laid down by this Regulation apply.

The maximum levels defined in the Annex for lettuces “grown in the open” apply.

EXCEEDING OF THE LIMITS

Aflatoxins

Groundnuts, other oilseeds, nuts, dried fruit, rice and maize which exceed the maximum limits specified in the Annex to the Regulation may be placed on the market as long as:

  • they are not intended for human consumption;
  • they do not exceed the maximum limits for these products which are to be sorted before human consumption..

Nitrates

Derogations may be granted to some countries for exceeding the maximum level of nitrates. They cover production and consumption in the territory of the country concerned of products such as fresh spinach (Belgium, Ireland and the United Kingdom) and lettuces (Ireland and the United Kingdom).

Dioxins and dioxin-like PCBs

This Regulation grants Finland and Sweden a derogation for exceeding the levels of dioxins and dioxin-type PCBs until 31 December 2011 for the following products, but only for production and consumption in the territory of salmon, herring, river lamprey, trout, char and vendace roe from the Baltic.

CONTROL AND SUPERVISION

The Member States are responsible for supervising and controlling the level of nitrates in vegetables, especially green leaf vegetables.

They shall communicate the results to the Commission by 30 June every year.

Moreover, they shall communicate to the Commission the result of surveys carried out on the presence of contaminants in food every year

DISPOSAL OF STOCKS

This Regulation permits stocks of food which exceed the maximum levels of contaminants placed on the market before the date of entry into force of the respective limits for the contaminants to be disposed of.

MAXIMUM LEVELS IN FOOD FOR CHILDREN

This Regulation lays down maximum levels as low as possible for food for babies and for infants and young children in order to protect the health of this vulnerable population group. These maximum levels also apply to food for infants and young children covered by Directive 2006/125/EC and Directive 2006/141/EC.

The maximum levels for infants and young children according to this Regulation are:

  • nitrates: 200 mg/kg;
  • Aflatoxin B1: 0.10 µg/kg;
  • Aflatoxin M1: 0.025 µg/kg;
  • Ochratoxin A: 0.5 µg/kg and the same maximum level for dietary foods for specific medical purposes, specifically for infants;
  • Patulin: 10 µg/kg;
  • Deoxynivalenol: 200 µg/kg;
  • Zearalenone: 20 µg/kg and the same level for maize-based formulae for infants and young children;
  • Fumonisins: 200 µg/kg for maize-based formulae for infants and young children
  • Lead: 0.020 mg/kg fresh weight;
  • Inorganic tin: 50 mg/kg fresh weight and the same level for preparations for infant formulae and follow-on formulae and for canned dietary foods for special medical purposes specifically for infants (not including dried and powdered products);
  • benzo(a)pyrene: 1 µg/kg fresh weight and the same maximum level for formulae for infants and follow-on formulae and for dietary foods for special medical purposes specifically for infants.
Key terms used in the act
  • Mycotoxins Certain types of moulds of fungoid origin produce powerful poisons, especially the family of mycotoxins. The term mycotoxin comes from the Greek (mycos), which means fungus, and the Latin (toxicum), which means poison. It designates toxic chemical substances produced by certain moulds which develop on certain foodstuffs, particularly cereals.

References

Act Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1881/2006

9.1.2007

Applicable as of 1.3.2007

OJ L 364 of 20.12. 2006

Amending act(s) Entry into force – Date of expiry Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1126/2007

30.9.2007

OJ L 255 of 29.9.2007

Regulation (EC) No 629/2008

23.7.2008

OJ L 173 of 3.7.2008

Regulation (EC) No 165/2010

9.3.2010

OJ L 50 of 27.2.2010

The successive amendments and corrections to Regulation (EC) No 1881/2006 have been incorporated in the original text. This consolidated versionis of documentary value only.

Related Acts

METHODS OF SAMPLING AND METHODS OF ANALYSIS

Regulation (EC) No 333/2007 laying down methods of sampling and analysis for the official controls for the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs [Official Journal L 88 du 29.3.2007].

Commission Regulation (EC) No 1883/2006 of 19 December 2006 laying down methods of sampling and analysis for the official control of levels of dioxins and dioxin-type PCBs in certain foodstuffs [Official Journal L 364 of 20.12.2006].

Commission Regulation (EC) No 1882/2006 of 19 December 2006 laying down methods of sampling and analysis for the official control of the levels of nitrates in certain foodstuffs [Official Journal L 364 of 20.12.2006].

Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in food [Official Journal L 70 of 4.3.2006].
Amended by:
Regulation (EU) No 178/2010 [Official Journal L 52 of 3.3.2010].

IMPORTS

Commission Regulation (EC) No 1152/2009 of 27 November 2009 imposing special conditions governing the import of certain foodstuffs from certain third countries due to contamination risk by aflatoxins and repealing Decision 2006/504/EC [Official Journal L 313 of 28.11.2009].

Ceramic objects in contact with foodstuffs

Ceramic objects in contact with foodstuffs

Outline of the Community (European Union) legislation about Ceramic objects in contact with foodstuffs

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Ceramic objects in contact with foodstuffs

Document or Iniciative

Council Directive 84/500/EEC of 15 October 1984 on the approximation of the laws of the Member States relating to ceramic articles intended to come into contact with foodstuffs [See amending acts].

Summary

Ceramic objects used to contain foodstuffs may transfer lead and cadmium to these foodstuffs. These two metals are toxic and can constitute a risk to human health.

The Directive lays down maximum limits for the cadmium and lead transferred by ceramic objects to the foodstuffs with which they enter into contact.

Declaration of conformity

To be sold, these ceramics must be accompanied by a written declaration provided by the manufacturer or importer, guaranteeing that they do not exceed the maximum limits for lead and cadmium. The information required is described in Annex II (introduced by Directive 2005/31/EC).

The declaration was introduced to meet the requirements of Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food (Directive 84/500/EEC is a measure specific to the groups of materials and objects listed in Regulation (EC) No 1935/2004).

The maximum limits for lead and cadmium must be checked by means of a test and a method of analysis (Annex III, introduced by Directive 2005/31/EC).

These methods take into account the very latest scientific progress in methods of analysis for official tests of lead and cadmium in foodstuffs, in accordance with Directive 2001/22/EC (see the Associated Acts heading below).

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Directive 84/500/EEC 17.10.1984 OJ L 277 of 20.10.1984; corrigenda: OJ L 114 of 27.04.1989 and OJ L 181 of 28.06.1989.
Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal
Directive 2005/31/EC 21.05.2005 20.05.2006
20.05.2007 (Ban on the production and import of products that do not meet the criteria)
OJ L 110 of 30.04.2005

Related Acts

Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the official control of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs [Official Journal L 88 of 29.3.2007].

Active and intelligent materials and articles

Active and intelligent materials and articles

Outline of the Community (European Union) legislation about Active and intelligent materials and articles

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Active and intelligent materials and articles

Document or Iniciative

Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food.

Summary

This Regulation establishes specific requirements for the marketing of active * and intelligent * materials and articles intended to come into contact with food. It supplements the general principles defined in Regulation (EC) No 1935/2004 and describes the procedure for the authorisation of substances at Community level.

Scope

This Regulation shall apply to active or intelligent materials and articles which are placed on the Community market.

Requirements for active and intelligent materials and articles

Active and intelligent materials and articles:

  • must be suitable and effective for the intended purpose of use;
  • must not release to food any components * in sufficient quantity as to endanger human health or to bring about an unacceptable change in the composition or organoleptic characteristics of food;
  • must not mislead consumers through their labelling, presentation or advertising material.

These specific requirements are without prejudice to Community or national provisions applicable to materials and articles to which active or intelligent components are added or into which they are incorporated.

Composition

Only substances which are included in the Community list of authorised substances may be used in components of active and intelligent materials and articles.

However, the following substances may be used in components of active and intelligent materials and articles without being included in the Community list:

  • released active substances, added or incorporated by techniques such as grafting or immobilisation which are used in full compliance with the relevant Community and national provisions (for example, legislation on food additives and food enzymes);
  • substances used in the components which are not in direct contact with food or the environment surrounding the food; and if they are not “mutagenic”, “carcinogenic”, or “toxic to reproduction” or substances produced deliberately in a particle size that exhibits chemical and physical properties that significantly differ from those at a larger scale.

Applications for authorisation of substances constituting the components of active and intelligent materials and articles

Applications for authorisation of substances constituting the components of active and intelligent materials and articles are to be made to the competent authorities of a Member State accompanied by a technical dossier containing the information described in the guide to safety assessment prepared by the European Food Safety Authority.

The Member State sends the application to the Authority which is responsible for assessing whether the substance meets the above conditions.

Community list of authorised substances

In order to be included in the Community list, substances constituting the components of active and intelligent materials and articles must meet the requirements that apply to the said products (see above).

The Commission shall adopt the Community list after the Authority has delivered its opinion on all substances for which a valid application for market authorisation has been submitted.

The Community list shall specify:

  • the identity of the substance(s);
  • the function of the substance(s);
  • the reference number;
  • if necessary, the conditions of use of the substance(s) or component.

Labelling

Active and intelligent materials and articles:

  • in contact with food are to be labelled appropriately to allow the consumer to identify the non-edible parts. In this case the words “DO NOT EAT” must be added to the label as well as (if possible) the symbol reproduced in Annex I;
  • labelled so that it is clear that they are active and/or intelligent.

Released active substances are considered as ingredients and are to be labelled pursuant to the general rules for the labelling of foodstuffs.

Application

The provisions relating to the composition of active and intelligent materials and articles apply from the date at which the Community list of substances that may be used in the composition of the said materials and articles enters into force.

The provisions on labelling apply from 19 December 2009.

Key terms of the Act
  • Active materials and articles: materials and articles 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 substances into or onto the packaged food or the environment surrounding the food.
  • Intelligent materials and articles: materials and articles which monitor the condition of packaged food or the environment surrounding the food.
  • A component: an individual substance or a combination of individual substances which cause the active and/or intelligent function of a material or article, including the products of an in situ reaction of those substances; it does not include the passive parts, such as the material they are added to or incorporated into.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 450/2009

19.6.2009

OJ L 135 of 30.5.2009

Materials and articles in regenerated cellulose film

Materials and articles in regenerated cellulose film

Outline of the Community (European Union) legislation about Materials and articles in regenerated cellulose film

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Materials and articles in regenerated cellulose film

Document or Iniciative

Commission Directive 2007/42/EC of 29 June 2007 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs.

Summary

This Directive is a specific directive provided for by Regulation (EC) No 1935/2004 concerning materials and articles intended to come into contact with food.

Scope

It applies to regenerated cellulose film which constitutes a finished product in itself, or forms part of a finished product containing other materials and which are intended to come into contact or are placed in contact with foodstuffs.

It does not apply to synthetic casings of regenerated cellulose.

Description

Regenerated cellulose film is defined as a thin sheet obtained from a refined cellulose derived from unrecycled wood or cotton. To meet technical requirements, suitable substances may be added either in the mass or on the surface. Regenerated cellulose film may be coated on one or both sides.

The regenerated cellulose films covered by this Directive belong to one of the following categories:

  • uncoated regenerated cellulose film;
  • coated regenerated cellulose film with coating derived from cellulose; or
  • coated regenerated cellulose film with coating consisting of plastics.

Authorised substances and restrictions

The Directive lays down a positive list of substances authorised in the manufacture of regenerated cellulose film with restrictions of use (see Annex II).

Regenerated cellulose films which are uncoated or coated with plastics may be manufactured with substances other than those specified in Annex II if they are employed as colouring matter or as adhesives, provided that there is no trace of migration of the substances into or onto foodstuffs.

Regenerated cellulose films which are coated with plastics shall comply with the provisions laid down by Regulation (EU) No 10/2011 concerning plastic materials and articles intended to come into contact with foodstuffs.

Printed surfaces of regenerated cellulose film shall not come into contact with the foodstuffs.

Marketing and labelling

At the marketing stages other than the retail stages, materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs shall be accompanied by a written declaration in accordance with Regulation (EC) No 1935/2004. However, materials and articles which, by their nature, are clearly intended to come into contact with foodstuffs are not subject to this obligation.

Where special conditions of use are indicated, the material or article made of regenerated cellulose film shall be labelled accordingly.

Context

This Directive codifies and repeals Commission Directive 93/10/EEC of 15 March 1993 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs and its amendments.

REFERENCES

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 2007/42/EC

20.7.2007

OJ L 172 of 30.6.2007

Recycled plastic materials and articles

Recycled plastic materials and articles

Outline of the Community (European Union) legislation about Recycled plastic materials and articles

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Recycled plastic materials and articles

Document or Iniciative

Commission Regulation (EC) No 282/2008 of 27 March 2008 on recycled plastic materials and articles intended to come into contact with foods and amending Regulation (EC) No 2023/2006.

Summary

This Regulation lays down specific measures for recycled plastic materials and articles, supplementing Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food.

Scope

This Regulation covers recycled plastic materials and articles which may come partially or totally into contact with food.

This Regulation does not apply to recycled plastic materials and articles:

  • made with monomers and substances derived from chemical depolymerization of plastic materials and articles;
  • made from unused production offcuts or process scraps;
  • in which the recycled plastic is used behind a plastic functional barrier *.

The materials and articles covered by this Regulation are subject to Regulation (EU) No 10/2011 on plastic materials intended for food packaging.

Requirements for recycled plastic materials and articles

The recycled plastic used for the manufacture of materials and articles covered by this Regulation must be obtained from an authorised recycling process. The said process is to be managed using a quality assurance system which complies with the rules laid down in the Annex of Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food.

Conditions for the authorisation of recycling processes

Authorisation may be granted if recycling processes comply with the following conditions:

  • the quality of plastic input must be characterised and controlled;
  • the plastic input must originate from plastic materials and articles that have been manufactured in accordance with Community legislation on plastic food contact materials and articles;
  • the recycling process must be able to guarantee that there can be no contamination or that it is reduced to a concentration that does not pose a risk to human health;
  • the conditions of use of recycled plastic must guarantee that the final materials and articles do not release into food components in a quantity likely to endanger human health or to bring about an unacceptable change in the composition of the food, or to bring about a deterioration in the organoleptic characteristics thereof.

Applications for authorisation of recycling processes

Applications for authorisation for a recycling process are to be made to the competent authority of a Member State accompanied by a technical dossier containing the information described in the guidelines for the safety assessment of a recycling process prepared by the European Food Safety Authority.

The Member State sends the application to the Authority which is responsible for assessing whether the said process meets the above conditions. Following a transitory phase, the Authority will have a period of six months from receipt of the application to give its opinion.

The Commission shall take into account the opinion of the Authority and adopt a Decision that it will send to the applicant. In this Decision, it will grant or refuse authorisation of the recycling process.

Community register

The Commission shall maintain a register of authorised recycling processes. The register shall be made available to the public.

Official control

Recycling plants and converters shall be subject to official controls. These controls aim at verifying that the recycling processes correspond to the processes for which authorisation was granted and that the quality assurance system is in place.

The authorisation holder shall notify the competent authority in the Member State about the recycling or manufacturing site in which the authorised recycling process is being applied. Member States shall send this information to the Commission who will keep updated a register of recycling sites in the Community and third countries.

Labelling of recycled plastic materials and articles

Voluntary self-declaration of the recycled content in recycled plastic materials and articles shall follow the rules laid down in ISO 14021:1999 or equivalent.

Declaration of compliance and record keeping

In addition to the conditions laid down by Regulation (EU) No 10/2011, the declaration of compliance of recycled plastic materials and articles shall certify that the recycled plastic used comes from an authorised recycling process and shall bear the EC register number corresponding to the recycling process.

In addition to the conditions laid down by Regulation (EU) No 10/2011, the declaration of compliance for recycled plastic materials shall certify that:

  • the recycling process has been authorised. A precise indication of the EC register number for the process;
  • the plastic input, the recycling process and the recycled plastic meet the specifications for which the authorisation has been granted;
  • a quality assurance system is in place.
Key terms of the Act
  • Plastic functional barrier: a barrier composed of one or several layers of plastic material ensuring that the finished material or article does not release into food components in a quantity likely to:
    1. endanger human health, or
    2. bring about an unacceptable change in the composition of the food, or
    3. bring about a deterioration in the organoleptic characteristics thereof.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 282/2008

17.4.2008

OJ L 86 of 28.3.2008

Extraction solvents used in foodstuffs

Extraction solvents used in foodstuffs

Outline of the Community (European Union) legislation about Extraction solvents used in foodstuffs

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Extraction solvents used in foodstuffs

Document or Iniciative

Directive 2009/32/EC of the European Parliament and of the Council of 23 April 2009 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients.

Summary

This Directive replaces Directive 88/344/EEC and establishes a single list of extraction solvents * for foodstuffs.

Extraction solvents

This Directive applies to extraction solvents used in the production of foodstuffs or food ingredients. It also applies to extraction solvents imported into the European Union (EU).

This Directive shall not apply to extraction solvents used in the production of food additives, vitamins and other nutritional additives (unless such food additives, vitamins or nutritional additives are listed in Annex I).

Use and marketing

Member States shall authorise the use on their territory of extraction solvents used in the production of foodstuffs or food ingredients. However, this is subject to compliance with conditions of use and permitted residues. Only extraction solvents listed in Annex I may be used.

Member States shall not prohibit, restrict or limit the marketing of a foodstuff or ingredient produced using an extraction solvent which meets the requirements of this Directive.

Water to which substances regulating acidity or alkalinity may have been added and other food substances which possess solvent properties are authorised as extraction solvents in the manufacture of foodstuffs or food ingredients.

Purity criteria

This Directive may, if necessary, establish specific purity criteria for the extraction solvents listed in Annex I, and in particular maximum permitted limits of mercury and cadmium.

The suspension or withdrawal of authorisation

A Member State may temporarily suspend or restrict an authorisation granted for an extraction solvent. To do this, the Member State must have grounds justifying that the solvent in question represents a risk for human health. It shall inform the Commission and the other Member States of its decision without delay.

The Commission shall examine the grounds cited as soon as possible and express an opinion. If appropriate, the Commission shall approve the measures taken by the Member State or supplement them with appropriate measures.

Labelling

This Directive lays down labelling requirements including:

  • the commercial name as indicated in Annex I;
  • a clear indication that the extraction solvent is of a quality suitable for use for the extraction of food or food ingredients;
  • the number of the batch or lot;
  • the commercial name of the manufacturer or packer;
  • the net quantity;
  • if necessary, the special storage conditions or conditions of use.

There may be exemptions from these labelling rules. Only the first two particulars (the commercial name and use) may appear on the label if the extraction solvents are accompanied by commercial documents for the batch or lot which include the remaining information.

The particulars must be easily visible, clearly legible and indelible. They must be expressed in a language which can be easily understood by the purchaser.

Key terms of the Act
  • Solvent: any substance for dissolving a foodstuff or any component thereof, including any contaminant present in or on that foodstuff.
  • Extraction solvent: a solvent which is used in an extraction procedure during the processing of raw materials, of foodstuffs, or of components or ingredients of these products and which is removed but which may result in the unintentional, but technically unavoidable, presence of residues or derivatives in the foodstuff or food ingredient.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 2009/32/EC

26.6.2009

JO L 141 of 6.6.2009

Arrangements for agricultural imports following Chernobyl

Arrangements for agricultural imports following Chernobyl

Outline of the Community (European Union) legislation about Arrangements for agricultural imports following Chernobyl

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Arrangements for agricultural imports following Chernobyl

Document or Iniciative

Council Regulation (EC) No 733/2008 of 15 July 2008 on the conditions governing imports of agricultural products originating in third countries following the accident at the Chernobyl nuclear power station [See amending act(s)].

Summary

This Regulation shall apply to agricultural products from third countries covered by:

  • Annex I to the Treaty on the Functioning of the European Union ;
  • Regulation (EC) No 1667/2006 on glucose and lactose;
  • Regulation (EC) No 614/2009 on ovalbumin and lactalbumin;
  • Regulation (EC) No 1216/2009 applicable to certain goods resulting from the processing of agricultural products.

This Regulation lays down the maximum permitted radioactive contamination levels to be complied with in order for agricultural products from third countries to be offered for sale on the European Union (EU) market. The accumulated maximum radioactive level in terms of caesium-134 and -137 shall be 600 Bq/kg. For milk and foodstuffs intended for infants, the maximum radioactive level shall be much lower, namely 370 Bq/kg. The level applicable to concentrated or dried products shall be calculated on the basis of the reconstituted product as ready for consumption.

Member States shall check compliance with these maximum permitted levels, taking into account contamination levels in the country of origin. Depending on the results of the checks carried out, Member States shall take the necessary measures and inform the Commission without delay. In cases of repeated non-compliance with the maximum permitted levels, these measures may take the form of a prohibition of the import of products originating in the third country concerned.

References

Act Entry into force – expiry date Deadline for transposition in the Member States Official Journal

Regulation (EC) No 733/2008

19.8.2008 – 31.3.2020

OJ L 201 of 30.7.2008

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 1048/2009

7.11.2009

OJ L 290 of 6.11.2009

Successive amendments and corrections to Regulation (EC) No 733/2008 have been incorporated into the basic text. This consolidated versionis for information only.

Plastic materials and articles

Plastic materials and articles

Outline of the Community (European Union) legislation about Plastic materials and articles

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Plastic materials and articles

Document or Iniciative

Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food.

Summary

This Regulation establishes specific requirements applicable to the manufacture and marketing of plastic materials and articles intended to come into contact with food. These requirements supplement the general provisions laid down in Regulation (EC) No 1935/2004 on materials and articles used for the packaging of food.

Materials

This Regulation applies to plastic materials and articles intended to come into contact with food. These materials and articles and parts thereof may be composed:

  • exclusively of plastics;
  • of several layers of plastics; or
  • of plastics combined with other materials.

This Regulation does not apply to ion exchange resins, rubber, or silicones.

The provisions on printing inks, adhesives or coatings supplement the requirements laid down in this Regulation.

Placing on the market

Plastic materials and articles intended to come into contact with food must comply with:

  • the requirements for use, labelling and traceability set out in Regulation (EC) No 1935/2004;
  • the good manufacturing practice defined in Regulation (EC) No 2023/2006;
  • the compositional and declaration requirements set out in this Regulation.

Authorised substances

Only the substances included in the list set out in Annex I may be intentionally used in the manufacture of plastic materials and articles. The list includes:

  • monomers;
  • additives (excluding colorants);
  • polymer production aids (excluding solvents); and
  • macromolecules obtained from microbial fermentation.

By way of derogation, substances not included on this list may be authorised under certain conditions.

Requirements on substances

This Regulation lays down the conditions of use for authorised substances (see Annex II) and migration limits (see Annex I). These migration limits correspond to the maximum amount of substances that materials and articles may transfer to food. They are expressed in mg of substance per kg of food (mg/kg).

All plastic materials and articles must comply with specific migration limits and overall migration limits.

The composition of each plastic layer constituting a material or article must comply with this Regulation. However, a layer which is not in direct contact with food may:

  • not comply with the restrictions and specifications of this Regulation (except for vinyl chloride monomer as provided in Annex I);
  • be manufactured with substances not included on the list of authorised substances (these substances must nevertheless not be mutagenic, carcinogenic or toxic to reproduction, or be in nanoform).

Declaration of compliance

The manufacturer shall draw up a written declaration containing the information set out in Annex IV. The information provided shall identify the materials, articles and products from intermediate stages of their manufacturing as well as the substances themselves. This declaration shall be renewed when substantial changes in the composition or production occur.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EU) No 10/2011

4.2.2011

OJ L 12, 15.1.2011

The successive amendments and corrections to Regulation (EC) No 10/2011 have been incorporated into the original text. This consolidated version  is of documentary value only.

Arrangements for exporting foodstuffs and feedingstuffs following a nuclear accident

Arrangements for exporting foodstuffs and feedingstuffs following a nuclear accident

Outline of the Community (European Union) legislation about Arrangements for exporting foodstuffs and feedingstuffs following a nuclear accident

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Contamination and environmental factors

Arrangements for exporting foodstuffs and feedingstuffs following a nuclear accident

Document or Iniciative

Council Regulation (EEC) No 2219/89 of 18 July 1989 on the special conditions for exporting foodstuffs and feedingstuffs following a nuclear accident or any other case of radiological emergency.

Summary

Foodstuffs and feedingstuffs in which the level of radioactive contamination exceeds the maximum permitted levels applicable on the internal market pursuant to Council Regulation (Euratom) No 3954/87 may not be exported.

Member States shall carry out checks to ensure that these maximum permitted levels are observed.

Each Member State must communicate to the Commission the fullest information on the application of this Regulation. The Commission shall forward this information to the other Member States.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EEC) No 2219/1989

25.7.1989

OJ L 211 of 22.7.1989

Related Acts

Council Regulation (EC) No 733/2008 of 15 July 2008 on the conditions governing imports of agricultural products originating in third countries following the accident at the Chernobyl nuclear power station [Official Journal L 201 of 30.7.2008].