Glossary

Macroscopic process of penetration of a substance into a condensed phase. More generally, it refers to macroscopic transport involving partitioning between two phases and molecular diffusion within the destination condensed phase.

A substance intentionally added to a plastic material in order to obtain a physical or chemical effect during the processing of the plastic material or to modify the physical or chemical characteristics of the final material or object, and which is intended to be present in the final material or object.

Source : Regulation (EU) n°10/2011

Any substance introduced into a food and intended to remain there, authorized by food legislation. Food additives belong to the following families: preservatives, antioxidants, colorants, flavoring agents, anti-caking agents, substances with a particular nutritional effect, etc.

A foodstuff for which, in migration tests, only foodstuff simulants other than simulants D1 (Ethanol 50%) or D2 (Vegetable oil) are designated in Annex III, Table 2, of Regulation (EU) No 10/2011.

Process with three components: risk assessment, risk management and risk communication

Source: Standard NF V 01 - 002

A substance that triggers polymerization and/or controls the formation of macromolecular structure.

Source : Regulation (EU) n°10/2011

A substance used to serve as a suitable medium for the manufacture of polymers or plastics, which may be present but is not intended to be present in final materials or articles and which does not alter the physical or chemical characteristics of the final material or article.

Source : Regulation (EU) n°10/2011

A functional barrier consists of one or more layers of any type of material that ensures that a layer of plastic, manufactured with substances not authorized by Regulation (EU) n°10/2011 and not classified as mutagenic, carcinogenic, reprotoxic or nanometric, is not in direct contact with a foodstuff and does not migrate above the detection limit of 0.01 mg/kg of foodstuff.

Characteristics perceived by the various senses, taking into account olfactory (smell), gustatory (taste), and if necessary visual (appearance, color), auditory (fizzing, crackling, noise, ...), tactile (consistency, roughness) aspects.

Substance which, when used in small proportions, initiates and/or increases the rate of a chemical reaction without apparently intervening in the composition of the products obtained.

Product circuits in which products circulate within a controlled system of reuse and distribution and in which recycled materials come only from these elements of the chain, so that the accidental introduction of outside materials corresponds to the minimum technically feasible.

Source : Regulation (EC) n°282/2008

The chemical activity of a species corresponds to the active concentration of that species in a non-ideal mixture. The activity coefficient reflects the non-ideal nature of the mixture. It relates the activity to a concentration Ci (in the case of a liquid mixture) or to a molar fraction xi (in the case of a gas mixture).

This is the constant of proportionality between the flow of matter due to molecular diffusion and the concentration gradient.

Henry's law establishes a relationship between the partial pressure p of a substance and its concentration C. Henry's coefficient is a constant expressed as the ratio of p and C.

The ratio of volume concentrations of a substance at equilibrium between F (Food) and P (Packaging).

This is the constant related to the material transfer rate across a transfer surface A and the molar concentration gradient.

A particular substance or a combination of different substances responsible for the active and/or intelligent function of a material or object, including the products of an in situ reaction of these substances. Passive parts, such as the material to which the substances are added or into which they are incorporated, are not constituents.

Source : Regulation n°450/2009

Any biological or chemical agent, foreign material or other substance not intentionally added to the food product that may compromise safety or wholesomeness.

Source: Standard NF V 01 - 002

Regulatory or non-regulatory analytical specifications for materials, substances or additives relating to:

• the nature of any impurities they may contain: traces of residual monomers, heavy metals
.
• their maximum permissible percentage (e.g.: impurity < 0.3%) or, a contrario, the product's minimum permissible purity level (e.g.: purity > 99.7%).

A biological, chemical or physical agent present in a food or condition of that food that may result in an adverse health effect.

Source: Standard NF V 01 - 002

In the chain of responsibility for packaging compliance with current regulations, the supplier must certify to its customer that the product (substance, preparation, material, object,...) it delivers for food application does indeed comply with regulations on materials and objects brought or intended to be brought into contact with foodstuffs.

This is the macroscopic mechanism opposite to sorption.

The term diffusion is generic and is understood as the transfer of substances in the absence of external forces (pressure gradient, electric field, mechanical stress...).

It involves the dispersion of a solute in the middle of other molecules (liquid, polymer) so that solute-solute interactions become negligible. Polymer dissolution corresponds to extreme swelling of the polymer until the polymer chains become disentangled.

The ADI is the amount of substance in mg/kg body weight that can be safely ingested by humans on a daily basis. This figure is used to assess the risk of substances used in the manufacture of foodstuffs.

The TDI is the maximum quantity of a substance that can be absorbed by a person, on a daily basis, over a lifetime, without any adverse health effects. This data is used to assess the risk of substances used in the manufacture of materials and which may migrate into foodstuffs.

To determine it: it is sometimes extrapolated from human data obtained during ecological disasters. But more often:

- the "maximum no-effect dose" is calculated from animal studies (e.g. a dose of 100 mg/day)

- we divide this dose by a safety factor, at least 100: division by 10 for extrapolation from the animal model to humans (whose organism may react differently to repeated ingestion of the compound) and division by 10 to take into account diversity at the human species level, and life expectancy.

If a compound can have mutagenic or carcinogenic effects at higher doses: the safety factor will be greater (for example: from the 100 mg/day dose admitted at animal level, we obtain a maximum admissible dose of 1 mg/day for humans, or even 0.5 or 0.2 mg/day...).

The minimum energy to be supplied to a chemical system for the reaction to take place.

Science-based process involving the following steps:

• Hazard identification
• Appreciation of consequences
• Appreciation of exposure
• Risk estimation

Source : Standard NF V 01 - 002

Factor used to express the result of a migration test in mg/kg of food by considering a ratio of 6 dm² of material surface for 1 kg of food in contact. This ratio is that of a 1dm³ cube with 6 faces of 1 dm². The overall migration limits of European plastics regulations (10 mg/dm² and 60 mg/kg) have been defined with this ratio in mind.

Correction factor for overall or specific migration test results that depends on the fatty food category (See Table 2 of Annex III to Regulation (EU) No 10/2011).

Factor for reducing specific migration results of lipophilic substances obtained in simulants foods fat that takes into account the fact that a person ingests daily an amount of fat of around 200 g and not of 1 kg, as is taken into account for other simulants of foodstuffs. This factor only applies to specific migration results for plastics in contact with foods containing more than 20% fat.

This is a significant sorption of a substance that leads to a significant change in the specific volume of the polymer and the distribution of associated free volumes.

HACCP: Hazard Analysis Critical Control Points

An approach that identifies, evaluates and controls hazards of food safety significance.

Source : Standard NF V 01 - 002

A set of conditions and measures necessary to ensure food safety and wholesomeness at all stages of the food chain.

Source : Norme NF V 01 - 002

The maximum permitted amount of non-volatile substances transferred from a material or article to food simulants.

Source : Regulation (EU) n°10/2011

The maximum permitted amount of a given substance transferred from a material or article to food or food simulants.

Source : Regulation (EU) n°10/2011

The maximum permitted sum of particular substances released to food or food simulants, expressed as the total of the grouping of substances indicated.

Source: Regulation (EU) n°10/2011

List of substances whose use is authorized, and which are specifically named in the regulations.

Materials and articles intended to extend the shelf life or to maintain or improve the condition of packaged foodstuffs designed to deliberately include constituents that release or absorb substances into the packaged foodstuffs or into the environment of the foodstuffs.

Source : Regulation n°450/2009

Active materials and objects that are designed to deliberately include constituents that release substances into or onto packaged food or the food environment.

Source : Regulation n°450/2009

Materials and objects composed of two or more layers of plastic.

Source : Regulation (EU) n°10/2011

Materials and objects that control the condition of packaged foodstuffs or the environment of foodstuffs.

Source : Regulation n°450/2009

Materials and articles composed of two or more layers of materials of different kinds, including at least one layer of plastic.

Source : Regulation (EU) n°10/2011

Polymer to which additives or other substances may have been added, capable of serving as the main structural component of final materials and objects. Regulation (EU) n°10/2011 excludes from its scope ion exchange resins, rubbers and silicones.

Source : Regulation (EU) n°10/2011)

Collected and sorted discarded plastic materials and objects used as raw material in a recycling process.

Source: Regulation (EC) n°282/2008

It is a generic term involving a movement of matter independently of the molecular mechanism: diffusion, advection, capillarity... In the field of contact materials, it is used to designate a transfer from the packaging compartment to the food compartment.

Substance subjected to any type of polymerization process in order to manufacture polymers, or natural or synthetic macromolecular substance used for the manufacture of modified macromolecules, or substance used to modify existing natural or synthetic macromolecules.

Source : Regulation (EU) n°10/2011

Nano-object whose three dimensions are on the scale, i.e. a particle with a nominal diameter of less than about 100 nm.

Source : Standard ISO TS/27687

This is a dimensionless number that characterizes the transfer resistance of the food side.

At thermodynamic equilibrium, chemical substances are divided according to their chemical affinity between two compartments: packaging (P: Packaging) and food (F: Food).

This term refers to the macroscopic mechanism involving transfer through a generally solid condensed phase. It includes sorption at one face, diffusion into the solid and then desorption at the opposite face.

Chemical substance, usually liquid, used in the composition of certain materials to give them flexibility during use.

This is an operation involving the incorporation of plasticizers to lower the glass transition temperature of a polymer.

Macromolecular substance obtained by a polymerization process, such as polyaddition or polycondensation, or any other similar process from monomers and other starting substances, or chemical modification of natural or synthetic macromolecules, or microbial fermentation.

Source : Regulation (EU) n°10/2011

Process in which plastic waste is recycled in accordance with the definition of recycling in Article 3(7) of Directive 94/62/EC on packaging and packaging waste; for the purposes of this Regulation, this term is limited to processes intended for the production of recycled plastics.

Source : Regulation (EC) n°282/2008

Product used for cleaning surfaces, materials, objects that come or may come into contact with foodstuffs.

Maximum permitted amount of substance in materials or articles intended for contact with food. The amount of the substance is determined by a validated method of analysis. If such a method does not exist, an analytical method with performance characteristics appropriate to the specified limit may be used pending the development of a validated method.

The natural or legal person responsible for ensuring that the requirements of regulation no. 282/2008 concerning the recycling process are met in the company under their control.

Source : Regulation (EC) n°282/2008

According to Regulation (EU) No. 10/20211, hot filling is the filling of any object with a foodstuff at a temperature not exceeding 100 °C at the time of filling, after which the foodstuff cools to a temperature of 50 °C or less in 60 minutes, or a temperature of 30 °C or less in 150 minutes.

Source : Regulation (EU) n°10/2011

A restriction on the use of a substance, a migration limit or a limit quantity of the substance in the material or object.

Source: Regulation (EU) n°10/2011

Function of the probability of an adverse health effect and the severity of that effect resulting from one or more hazards in a food. Risk can be expressed as the probability of being exposed to the hazard.

Source : Standard NF V 01 - 002

Assurance that food will not cause harm to consumers when prepared and/or consumed in accordance with its intended use.

Source: Standard NF V 01 - 002

The Threshold of Toxicological Concern (TTC) approach was developed to qualitatively assess the risk associated with substances at low concentrations in the diet. It can be used for the initial assessment of a substance to determine whether a full risk assessment is required. It is an important scientific approach for prioritizing the assessment of chemicals with low-level exposures that require more data, as opposed to substances that can be assumed to present no appreciable risk to human health.

Source: EFSA

A test medium that mimics a foodstuff and, through its behavior, reproduces migration from materials intended to come into contact with food.

Source : Regulation (EU) n°10/2011

It involves the dispersion of a solute in the middle of other molecules (liquid, polymer) so that solute-solute interactions become negligible. Polymer dissolution corresponds to extreme swelling of the polymer until the polymer chains are disentangled.

Macroscopic process of penetration of a substance into a condensed phase. More generally, it refers to macroscopic transport involving partitioning between two phases and molecular diffusion within the destination condensed phase.

The composition of a substance, the purity criteria of a substance, the physicochemical characteristics of a substance, indications relating to the manufacturing process of a substance or additional information concerning the expression of migration limits.

Source : Regulation (EU) n°10/2011

Substances refer to chemical elements or their compounds as they occur in the natural state or as produced by industry.

Substances intended to be released by active releasing materials and objects in or on packaged foodstuffs or the foodstuff environment and fulfilling a function in these foodstuffs.

Source : Regulation n°450/2009

An impurity in the substances used, a reaction intermediate formed during the production process or a decomposition or reaction product.

Source : Regulation (EU) n°10/2011

Conventional sign symbolizing a glass and a fork and which can accompany materials and objects ofintended to come into contact with the foodstuffs.

Image

Demonstrating the effectiveness of a recycling process in removing chemical contamination from plastic materials or objects.

Source : Regulation (EC) n°282/2008

Source: Wikipedia

The natural or legal person responsible for ensuring that the requirements of regulation no. 282/2008 on recycled plastic materials and articles are met in the company under their control.

Source : Regulation (EC) n°282/2008

Plastic articles as described in article 1^er of regulation (EU) n°10/2011 and falling under CN code ex 3924 10 00.

Source : Regulation (EC) n°284/2008