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Novel food safety testing

The success of your novel food begins with quality human safety toxicology analysis. Get the safety testing and regulatory support you need to accelerate your novel food program.
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What are novel foods and food improvement agents?

What are novel foods and food improvement agents?

A novel food is a food that is new or changed when compared to existing food products. It can include foods derived from new sources or substances or produced using new technologies or methods.

Food improvement agents are important as they can provide new sources of nutrition and can help address challenges like population growth, climate change and food insecurity. Novel food ingredients, additives, and products benefit greatly from an in-depth safety analysis that meets regulatory requirement and reduces risk in development.

At Labcorp, we collaborate with you by offering decades of experience in analytical chemistry, toxicology and metabolism along with regulatory guidance to determine that your novel food or food improvement agent is safe for human consumption.

Novel ingredients and products we help analyze:

Novel preservatives and antioxidants

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Bioengineered ingredients

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Texture modifiers and stabilizers

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Flavor enhancers and sweeteners

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Nutritional fortifiers and functional ingredients

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Enzymes and processing aids

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Plant-based and alternative protein sources

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Food additives

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Food colorings

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Gain clear insights from our trusted novel food toxicology testing
 

Regulatory support:

  • Literature data search

Physical chemistry:

  • Stability testing
  • Five batch analysis
  • Certification of analysis

Genotoxicity:

  • Literature data search support
  • In vitro genotoxicity test battery

ADME:

  • Literature data search support
  • Physiochemical studies and data
  • In vitro studies on absorption
  • Comparative metabolism in vitro studies
  • Pharmacokinetics

 

 

 

ADME

  • Single does administration studies
  • Repeated dose administration studies

Genotoxicity

  • In vivo genotoxicity studies
  • Evidence for target tissue exposure

Repeated dose toxicity:

  • Mechanistic and investigative studies to assess specific toxicity

Developmental, endocrine and reproductive toxicity:

  • Reproductive, fertility and/or endocrine disruption Studies
  • Neurotoxicity
  • Immunotoxicity
  • Other DART and endocrine related studies

Genotoxicity

  • Chronic toxicity studies
  • Carcinogenicity studies

Repeat dose - toxicity

  • Extended one generation reproductive toxicity study

Regulatory Support Services

  • Literature data search
  • Dossier redactions & privacy compliance
  • Study notifications
  • Manuscript preparation
  • Publication preparation & assistance

Regulatory support:

  • Literature data search

Physical chemistry:

  • Stability testing
  • Five batch analysis
  • Certification of analysis

Genotoxicity:

  • Literature data search support
  • In vitro genotoxicity test battery

ADME:

  • Literature data search support
  • Physiochemical studies and data
  • In vitro studies on absorption
  • Comparative metabolism in vitro studies
  • Pharmacokinetics

 

 

 

ADME

  • Single does administration studies
  • Repeated dose administration studies

Genotoxicity

  • In vivo genotoxicity studies
  • Evidence for target tissue exposure

Repeated dose toxicity:

  • Mechanistic and investigative studies to assess specific toxicity

Developmental, endocrine and reproductive toxicity:

  • Reproductive, fertility and/or endocrine disruption Studies
  • Neurotoxicity
  • Immunotoxicity
  • Other DART and endocrine related studies

Genotoxicity

  • Chronic toxicity studies
  • Carcinogenicity studies

Repeat dose - toxicity

  • Extended one generation reproductive toxicity study

Regulatory Support Services

  • Literature data search
  • Dossier redactions & privacy compliance
  • Study notifications
  • Manuscript preparation
  • Publication preparation & assistance

Supporting you through a tiered testing approach for novel foods

Leverage Labcorp’s testing portfolio to meet global regulatory requirements

The image is a structured flowchart outlining a tiered approach to assessing ADME (Absorption, Distribution, Metabolism, and Excretion), Genotoxicity, and Repeated Dose Toxicity. It is divided into three main columns, each representing one of these aspects, and further organized into three tiers. In the ADME section, the first tier includes literature data, physicochemical data, in vitro absorption data, and comparative metabolism studies. The key focus at this stage is identifying whether a novel food or its constituents are absorbed, with evidence for accumulation in the body or the formation of concerning metabolites. The second tier assesses substantial differences in ADME between species, incorporating information from single and repeated dose administration studies. The third tier examines differences in in vitro metabolism between test species and humans, looks for evidence of bioaccumulation, and may involve ADME studies in humans. The Genotoxicity section starts with literature data and an in vitro genotoxicity test battery in the first tier. The primary consideration here is whether positive or ambiguous findings suggest potential genotoxicity. If needed, the second tier moves to in vivo genotoxicity tests targeting relevant tissues. The third tier, in cases where further evaluation is required, leads to chronic toxicity and carcinogenicity studies. The Repeated Dose Toxicity section begins with literature data and subchronic toxicity studies in the first tier, focusing on identifying evidence for specific toxicity, such as effects on reproductive organs, fertility, endocrine function, neurotoxicity, and immunotoxicity. The second tier involves mechanistic and investigative studies to assess specific toxic effects, including cell proliferation and hyperplasia. The third tier evaluates evidence of reproductive, immune, or neurotoxicity, potentially leading to extended one-generation reproductive toxicity studies or chronic toxicity and carcinogenicity studies. The flowchart uses arrows and dashed lines to indicate the relationships between different evaluation stages, illustrating how findings in one tier may lead to further testing or escalate to higher-tier assessments.

EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA); Turck D, Bohn T, Castenmiller J, de Henauw S, et al. EFSA J. 2024;22(9):e8961. doi:10.2903/j.efsa.2024.8961

New approach methods and in vitro alternatives are available to meet regulatory requirements

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In vitro alternatives and new approach methods for novel food safety analysis

EFSA, FDA, SFA and other regulatory bodies already require in vitro studies as part of their submission guidelines within metabolism (ADME) and genotoxicity, but you can also leverage other advanced methods that don't involve animal testing to help accelerate development while reducing risk during the safety analysis stage.

In silico assessment uses advanced computation modelling to predict the potential toxicity of a compound rapidly. Meaningful in silico predictions can only be made after understanding the chemistry, toxicology and statistical basis behind these QSAR models. By working with us, you gain access to our diverse team of computational biologists, statisticians, chemists and toxicologists who are prepared to match your needs.

Advance your novel food with tailored solutions to make sure it's safe for plate

Every food improvement agent is unique. That's why we work closely with you to determine the best approach for your product. This includes:

  • Rapid study execution and customized reporting: Our streamlined processes provide quick turnarounds on study execution and report delivery, helping you meet or exceed key development milestones. Our tailored reports align with the redaction and privacy requirements of dossiers for your regulatory submission

  • In-house global laboratory network: All testing is conducted in-house within our global network of laboratories, offering quality, consistency and efficiency

  • Analytical techniques: Our experience includes offering analytical techniques like LC-MS, GC-MS and ELISA for all applicable novel food testing samples

  • Experienced team of scientists: Our scientific team has the specialized skill sets to accurately and confidently complete your toxicology, physical chemistry and metabolism studies with the quality science and insights you need and a turnaround time you desire

Labcorp is committed to being your trusted laboratory partner for human safety assessment for your food improvement, food additive and novel food development. Gain support developing a fit-for-purpose testing strategy to bring your next food innovation to market with comprehensive testing capabilities, regulatory guidance and tailored solutions.

Latest news:

Safety testing capabilities and regulatory support to accelerate your novel food development

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Novel foods testing FAQ:

The EU defines novel food as food that had not been consumed to a significant degree by humans in the EU before 15 May 1997, when the first Regulation on novel food came into force.

'Novel Food' can be newly developed, innovative food, food produced using new technologies and production processes, as well as food which is or has been traditionally eaten outside of the EU.

Food comprised of new food sources or substances that have not or are not commonly used as food ingredients. Benefits include new dietary choices or a new source of nutrients.

Examples of Novel Food include new sources of vitamin K (menaquinone) or extracts from existing food (Antarctic Krill oil rich in phospholipids from Euphausia superba), agricultural products from third countries (chia seeds, noni fruit juice), or food derived from new production processes (UV-treated food (milk, bread, mushrooms and yeast).

A novel food that has not been consumed to a significant degree in the EU before May 15, 1997

Novel food safety assessment studies include:

Physical Chemistry:

  • Stability tetsing
  • 5 batch analysis
  • Certification of Analysis
  • Pharmacokinetics

Genotoxicity:

  • OECD 471 AMES (including treat & wash)
  • OECD 487 in vitro micronucleus test
  • OECD 474 in vivo mammalian micronucleus test
  • OECD 488 transgenic rodent somatic and germ cell gene mutation assay
  • OECD 489: in vivo Mammalian Alkaline Comet Assay 
  • OECD474/489 - in vivo Rodent Combined Micronucleus-Comet Assay

Metabolism (ADME):

  • OECD 417: Toxicokinetics
  • In vitro digestibility
  • Non GLP feasibility in vitro comparative study
  • Main digestibility study, in vitro comparative study (2 species)
  • Main CaCo-2 study Caco
  • 2 Cell Permeability

Repeated Dose-Toxicity:

  • 14 day subacute -OECD 408 90-day sub chronic toxicity study
  • OECD 440: Uterotrophic Bioassay in Rodents
  • OECD 441: Hershberger Bioassay in Rats
  • OECD 455: Performance - Based Test Guideline for Stably Transfected Transactivation In Vitro Assays to Detect Estrogen Receptor Agonists and Antagonists
  • OECD 456: H295R Steroidogenesis Assay
  • OECD 451: Chronic toxicity & carcinogenicity - long-term carcinogenicity study 
  • OECD 452: Chronic toxicity study
  • OECD 453: Chronic toxicity and carcinogenicity testing of chemicals

DART/Endocrine:

  • OECD 421: Reproduction/Developmental Toxicity Screening Test
  • OECD 422: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test
  • OECD 414: Prenatal Developmental Toxicity Study (rat & rabbit species)
  • OECD 426: Developmental neurotoxicity study 
  • OECD 443: Extended one-generation reproductive toxicity study
  • OECD 416: Two-Generation Reproduction Toxicity

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