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Color Regulatory Affairs Quality Standards for Colors a Safety

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Color Regulatory Affairs Quality Standards for Colors a Safety Color Regulatory Affairs Quality Standards for Colors A safety perspective for the brands Sue Ann McAvoy, MS, CFS Sensient Colors LLC September 23, 2015 Why do we use colorants? Effective Color Usage Drives Consumer Trial and Acceptance • …a lasting color impression is made within 90 seconds and accounts for 60 percent of the acceptance or rejection of an object … • Color has a major impact on flavor perception and flavor acceptance. • Color plays a critical role in product identification. Research has indicated that people “see” flavors (Acree 2013, Lewis and others 2008), i.e, they form an opinion about the flavor of a food or beverage, based on its color. What is Permitted Worldwide? Issues Facing the Global Color Industry .Southampton Study .Sustainability Image can be enhanced by renewable natural colors .Ongoing food safety issues .Lack of specific quality and safety specifications in the regulations .On going import detentions involving color Synthetic Raw Materials Under Pressure • Increasing concern and Central Government activity around chemical industry in China and India • Availability of raw materials has become much more volatile • Cost are increasing and needs for environmental controls become more wide spread • Cost could double for synthetic colors over next 2 – 3 years • Natural colors may become an attractive alternatives from a supply security and environmentally responsible standpoint. Trends Towards Color from Naturals Sources in Europe CONFIDENTIAL Global Food Colours Market by Country/Region, 2012 17% 9% 36% Europe US 10% Japan China 28% Other Source: Leatherhead Food Research What are the risks we face with color specifications globally? Food Contamination Scares Synthetic dye ADULTERATION of natural colors Sudan dyes in Turmeric and Paprika CONFIDENTIAL 9 Food Safety Issues in the News • Extraction solvents not approved for use in colors – varies by region • Residuals solvents in excess of >1,000 ppm • Lead and mercury contamination in Carmine • Pesticide residues in Paprika • Dioxin in Paprika • Bacterial and pathogen contamination 10 Food Safety Issues in the News • Aromatic amines out of specification in synthetic colors • Beverage cloud adulterated with plasticizer • Synthetic dye adulteration of natural colors • Carthamus adulterated with Orange II • Saffron adulterated with Carthamus • Brick in Paprika • Sudan dyes in Turmeric and Paprika 11 Product Recalls • All raw materials have a risk profile that needs to be examined. • Product recalls are most importantly a public health issue! • They are also a significant economic issue. • The average cost of a recall to a food company is $10M USD in direct costs, in addition to brand damage. • 58% Leading Food Manufacturers in the US has at least one recall in the last five years. • Recalls can cause FDA and other regulatory bodies to come for inspections at the food manufacturing plants. • What can we do to help prevent them……? 12 What can we do to prevent them…..? • Clearly evaluate the supply chain for risks • These will vary by product, region, manufacturing process and storage conditions • Establish more robust standards – Current standards are not very detailed and tend to focus on the color itself – Need to establish more robust standards based on key risk factors such as microbiological, heavy metals, pesticide, adulteration and the use of unauthorized solvents. – Need to establish supplier reliability programs and full raw material traceability. 13 What are the risks we face with color specifications globally? International References (Links) International Regulations CFR21 Parte 74 Listing of Color http://www.accessdata.fda.gov/scripts/cdrh/cfd Additives Subject to Certification ocs/cfcfr/CFRSearch.cfm?CFRPart=74 Cfr21 Parte 73 Listing of Color http://www.accessdata.fda.gov/scripts/cdrh/cfd Additives Exempt from Certification ocs/cfcfr/CFRSearch.cfm?CFRPart=73 JECFA "Combined Compendium Of http://www.fao.org/food/food-safety- Food Additive Specifications" quality/scientific-advice/jecfa/jecfa-additives/en/ Standard 231/2012/EC Laying Down http://eur- Specifications For Food Additives lex.europa.eu/LexUriServ/LexUriServ.do?uri=O Listed In Annexes II And III To J:L:2012:083:0001:0295:ES:PDF Regulation (EC) No 1333/2008 Norma General Del Codex Para Los http://www.codexalimentarius.net/gsfaonline/in Aditivos Alimentarios dex.html?lang=es Codex Stan 192-1995 15 Risk Factors Managing the Key Risk Factors for Colors Hazard Mitigation Strategy Chemical Incoming materials in synthetic colors can bring unwanted contamination (FDA, EU & Codex) Microbiological Test all incoming raw materials for pathogens. Test all finished products for pathogens and spoilage organisms Heavy Metals Test for most common heavy metals (FDA, EU & Codex) Pesticides Test for pesticides that are not allowed (EPA, EU & Codex) Adulteration Test for synthetic dyes or other additives that adulterate product. Screening established for unknown adulterants. Unauthorized Solvents Map all supplier process and detail solvents used to ensure they meet all local regulations. Test for the presence of solvents. Supplier Reliability All vendors should be “certified” by the manufacturer. Raw Material Traceability Need full traceability for all ingredients Synthetic Colors Inherent risks for Synthetic Colors Aromatic Amines Component Yellow 5 Yellow 6 Red 2 Red 5 Red 6 Red 40 Sudan I X Sudan Red G X Aniline X X X X X X DONS X X Para-Cresidine Acid X SC-NTR X Fast Red X X X Sodium Naftionate X X Sulfanílic Acid X X Pirazolona T X Low Sulfonate X 4-aminobenzene X X 4-aminophenile X X Azobezene X X Schaeffer Salt X X 1,3-difeniltriezen X Benzinidine X Neville Winter X 19 Anilina en la Propuesta 65 de California STATE OF CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT SAFE DRINKING WATER AND TOXIC ENFORCEMENT ACT OF 1986 CHEMICALS KNOWN TO THE STATE TO CAUSE CANCER OR REPRODUCTIVE TOXICITY 20-jul-12 NSRL or Listing MADL Chemical Type of Toxicity CAS No. Date Listed a Mechanism (µg/day) Aniline cancer AB 62-53-3 01-ene-90 100 The Aniline is most representative the Aromatic Amine Aniline is toxic by inhalation of the vapour, ingestion, or percutaneous absorption. Aniline damages hemoglobin, a protein that carries oxygen in the blood. The damaged hemoglobin can not carry oxygen. This condition is known as methemoglobinemia and its severity depends on the amount of aniline which was exposed and the duration of exposure. It has permanent carcinogenic effects on rats that have ingested contaminated food with aniline, developing spleen cancer, so it appears to be carcinogenic in humans. 20 Amines Results in Amarillo No. 5 (Tartrazine) PT AS P5 EC P7 EPT BS AMINES Market HPLC COLOR COMMENTS sample (100 ppb PROFILE (0.2% Máx) (0.2 % Máx) (1% Máx) (1% Máx) (1% Máx) (0.1% Máx) (0.5% Máx) Máx) NOT Stange Pick 1 0.33 0.04 0.14 0.01 0.1 0.06 0.05 11.32 APPROVED 2 0.01 0.01 0.26 0.09 0.11 0.01 0.04 9.08 APPROVED APPROVED NOT 3 0.11 0.02 0.12 0 0.01 0.04 0.05 17.02 APPROVED APPROVED NOT 4 0.19 0.3 0.33 0.3 0 0.08 0.01 4.92 APPROVED APPROVED AMARILLO NOT 5 0.27 0.19 0.67 0.37 0.01 0.18 0.01 4.32 Stange Pick 5 APPROVED NOT Stange Pick 6 0.03 0.08 0.24 0.11 0.01 0 0 74.9 APPROVED NOT NOT 7 0.15 0.04 1.61 2.42 0.02 0.08 0.01 MI APPROVED APPROVED ATYPICAL NOT 8 0.41 0.06 0.83 0.01 0.09 0.06 0.01 161.46 PICKS APPROVED NOT NOT 9 0.502 0.175 0.297 0.254 0.344 0.014 0.005 124.85 APPROVED APPROVED 21 Componentes con Riesgos Inherentes: Intermediarios /Subsidiarios Compound Yellow 5 Yellow 6 Red 2 Red 5 Red 6 Red 40 Sudan I X Sudan Red G X Aniline X X X X X X DONS X X Para-Cresidine Acid X SC-NTR X Fast Red X X X Sodium Naftionate X X Sulfanílic Acid X X Pirazolone T X Low Sulfonate X 4-aminobenzene X X 4-amiofphenile X X Azobenzene X X Schaeffer Salt X X 1,3-difeniltriezene X Benzinidine X Neville Winter X 22 Cromatographic Profile Yellow No. 5 Standard Market Sample 23 23 Natural Colors Chemical JECFA monograph for Annatto CONFIDENTIAL 26 CONFIDENTIAL 27 CONFIDENTIAL 28 Chemical Specifications for Natural Colors • Botanical Standards will provide a reference used by all in the industry • Botanical Standards will be the guidance for sourcing • These standards will give a better definition of product quality • Technology exists that allows for authentication of natural colors • Industry standards will promote coordination of standards efforts with FDA , EC and JECFA. • Standards will offer brand protection of all companies in the supply chain Microbiological Microbiological Contamination • Natural color sources carry risk of microbial contamination exists. • Testing • Spoilage organisms • Indicator organisms • Pathogens (Salmonella, Listeria, E. coli, S. aureus) • Mycotoxins • Microsystins- bacterial toxin • Every batch should be tested. Heavy Metals Heavy Metals Mercury Arsenic Lead Cadmium Total Heavy Metals FDA 21CFR <1 ppm <3 ppm <10 ppm HC (Canada) <3 ppm <10 ppm <40 ppm EC 231/2012 <1 ppm <3 ppm <2 ppm <1 ppm <40 ppm JECFA <1 ppm <2 ppm <40 ppm JFSA (Japan) <2 ppm <2 ppm <20 ppm GB (China) <1 ppm <1 ppm <10 ppm <20 ppm Why do Heavy Metals cause health problems? • Heavy Metals- are toxic for humans in high concentrations • Lead • Arsenic • Mercury • Cadmium 34 Otro caso de Metales Pesados: Dióxido de Titanio Market Sample 1 Market Sample 2 Market Sample 3 PARAMETERS LIMITS* RESULTS RESULTS RESULTS Purity 99.0 % min. 99.2% 89.89% 99.30 % Loss in Dried to 105 ºF 0.5 % máx 0.40% 0.35% 0.410 % Insoluble matter in 0.5 % máx.
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