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How to Prepare a Food Contact Substance Notification for EU

By Little Pro on 2017-06-05 Views:  Update:2017-07-10

In EU, new substances (i.e.,additive) to be used to manufacture certain food contact materials (FCMs) such as plastic FCMs must be authorised at EU level first. In this article, we will give you a brief summary of authorisation procedure, how to prepare an application dossier and data needed for safety assessment. We will use plastic FCMs as an example . For other types of food contact materials (i.e., paper, inks) for which there is no harmonized regulation at EU level, please refer to material-specific national food contact legislation.

Procedure of Food Contact Substance Notification in EU

Any person (including non-EU legal entities)  seeking an authorisation for a plastic FCM substance can submit an application to the competent authority of a Member State, which will then forward the application to the European Food Safety Authority (EFSA). EFSA will check the validity of the application according to the EFSA Guidance and make proposals.

The following documentation needs to be submitted to the national authority of a Member State and European Reference Laboratory (EURL-FCM).

 Authority Required Documentation
Member State
  • Part A administrative information including applicant’s contact details, substance name and intended use.
  • Part B technical dossier including safety data, migration data, study reports and references. 
  • Part C Justification for confidential information
EURL-FCM
  • A physical sample of the substance (250 g);
  •  the relevant safety data sheet and spectroscopic data;
  •  the analytical method(s) including performance parameters
  • Part A - administrative info

Structure of A Technical Dossier

The technical dossier for the application of the authorisation of a new food contact substance consists of 9 sections. It must be prepared in a Word format.

 Section Detailed Requirements
0 SUMMARY OF THE DOSSIER A summary of the technical dossier including information on identity, intended use in the plastic materials, type of contact food, conclusion on migration tests and toxicological studies.
1 IDENTITY OF SUBSTANCE Substance name, identifiers, structure, purity, manufacturing details and specification.
2 PHYSICAL AND CHEMICAL PROPERTIES Melting point, boiling point, decomposition temperature, solubility, logPow, reactivity, stability, hydrolysis, etc.
3 INTENDED APPLICATION OF SUBSTANCE Intended food contact materials, technological function, max percentage in formulation,  process temperature, food to contact, time and temperature, surface to volume ration, etc.
4 AUTHORISATION OF SUBSTANCE Whether it has been authorised for use by a Member State, USA, Japan or other countries
5 DATA ON MIGRATION OF SUBSTANCE
  • Specific migration (test sample, food simulant, contact mode and temperature, treatment method, result)
  • Overal migration (test sample, food simulant, contact mode and temperature, treatment method, result); and 
  • Quantification and identification of migrating oligomers and reaction products derived from monomers and starting substances:
6 DATA ON RESIDUAL CONTENT  IN THE FCM
  • Actual content
  • Materials and methods
  • Residual content versus specific migration
7 MICROBIOLOGICAL PROPERTIES Needed if a substance is used as an antimicrobial agent.
8 TOXICOLOGICAL DATA
  • 8.1.1 Bacterial reverse mutation assay
  • 8.1.2 In vitro mammalian cell micronucleus test
  • 8.1.3 In vivo micronucleus test
  • 8.1.4 In vivo Comet assay
  • 8.1.5 Transgenic rodent gene mutation assay:
  • 8.2.1 Repeated dose 90-day oral toxicity study:
  • 8.2.2 Combined chronic toxicity/carcinogenicity:
  • 8.2.3 Reproduction/teratogenicity
  • 8.3.1 Absorption, distribution, biotransformation and excretion
  • 8.3.2 Accumulation in man
  • 8.4.1 Effects on immune system
  • 8.4.2 Neurotoxicity
  • 8.4.4 Other information:
9 LIST OF REFERENCES AND TECHNICAL ANNEXES Study reports, study summaries, references, etc.

Note: Not all toxicological studies listed above are required. The amount of toxicity data needed is related to the expected human exposure level, in accordance with the principle that the higher the exposure, the greater the amount of data required.

Tiered Toxicity Testing

Not all chemicals used in the manufacture of FCM will migrate into food. Many will form a stable part of a polymer, some will migrate only in minute quantities, if at all, and others will disappear during production, whereas yet others will decompose completely to result in either no or extremely low consumer exposure.Consequently, the amount of toxicity data needed should be related to the expected human exposure level.  The table below lists tiered approach to toxicity testing recommended by EFSA.

Tier Toxicity data required Other Considerations
Tier 1: Human exposure up to 1.5 μg/kg bw per day or if the substance is classified as Cramer class I and exposure is less than 30 μg/kg bw per day
  • Genotoxicity studies 
  • Available information including an appropriate literature search 
No other toxicity studies are required. Exceptions are: (1) if there are existing data indicating the potential to affect endocrine or neural systems; (2) for substances with a high potential to accumulate in humans; (3) for nanomaterials,
Tier 2: Human exposure from 1.5 to 80 μg/kg bw per day
  • + 90d repeated dose toxicity in rodents
If accumulation potential is anticipated, ADME study should be provided. If endocrine activity is expected, a 90-day study with a prenatal treatment period or an extended one-generation reproduction toxicity study (EOGRTS) should be considered.
Tier 3: Human exposure higher than 80 μg/kg bw per day
  • + Study on ADME
  • + Studies on reproduction and developmental toxicity
  • + Studies on long-term toxicity/carcinogenicity
If there are existing data indicating endocrine activity suggesting potential effects from prenatal exposure, a chronic study with a prenatal treatment period or an EOGRTS should be considered.

For genotoxicity studies, the following 2 tests are recommended by EFSA as minimum data requirement since this combination fulfils the basic requirements to cover the three genetic endpoints (gene mutations, structural and numerical chromosome aberrations).

  • a bacterial reverse mutation assay (OECD Test Guideline (TG) 471);
  • an in vitro mammalian cell micronucleus test (OECD TG 487).

The following in vivo tests would be suitable for following up substances that test positive in the above in vitro base set:

  • the in vivo micronucleus test (OECD TG 474);
  • the in vivo Comet assay (OECD 489);
  • the transgenic rodent gene mutation assay (OECD TG 488).

References

 

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