color regulatory affairs quality standards for colors a

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

Europe

Source: Leatherhead Food Research

What are the risks we face with color specifications globally?

CONFIDENTIAL 9

Food Contamination Scares

Synthetic dye ADULTERATION

of natural colors

Sudan dyes in Turmeric and Paprika

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

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

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……?

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.

What are the risks we face with color specifications globally?

International References (Links)

International Regulations

CFR21 Parte 74 Listing of Color

Additives Subject to Certification http://www.accessdata.fda.gov/scripts/cdrh/cfd

ocs/cfcfr/CFRSearch.cfm?CFRPart=74

Cfr21 Parte 73 Listing of Color

Additives Exempt from Certification http://www.accessdata.fda.gov/scripts/cdrh/cfd

ocs/cfcfr/CFRSearch.cfm?CFRPart=73

JECFA "Combined Compendium Of

Food Additive Specifications"

http://www.fao.org/food/food-safety-

quality/scientific-advice/jecfa/jecfa-additives/en/

Standard 231/2012/EC Laying Down

Specifications For Food Additives

Listed In Annexes II And III To

Regulation (EC) No 1333/2008

http://eur-

lex.europa.eu/LexUriServ/LexUriServ.do?uri=O

J:L:2012:083:0001:0295:ES:PDF

Norma General Del Codex Para Los

Aditivos Alimentarios

Codex Stan 192-1995

http://www.codexalimentarius.net/gsfaonline/in

dex.html?lang=es

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

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

Aniline cancer AB 62-53-3 01-ene-90 100

Chemical Type of Toxicity Listing

Mechanism CAS No. Date Listed

NSRL or

(µg/day)a

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.

Amines Results in Amarillo No. 5 (Tartrazine)

COLOR Market

sample

PT AS P5 EC P7 EPT BS AMINES HPLC

PROFILE COMMENTS

(0.2% Máx) (0.2 % Máx) (1% Máx) (1% Máx) (1% Máx) (0.1% Máx) (0.5% Máx) (100 ppb

AMARILLO

1 0.33 0.04 0.14 0.01 0.1 0.06 0.05 11.32 Stange Pick NOT

APPROVED

2 0.01 0.01 0.26 0.09 0.11 0.01 0.04 9.08 APPROVED APPROVED

3 0.11 0.02 0.12 0 0.01 0.04 0.05 17.02 APPROVED NOT

APPROVED

4 0.19 0.3 0.33 0.3 0 0.08 0.01 4.92 APPROVED NOT

APPROVED

5 0.27 0.19 0.67 0.37 0.01 0.18 0.01 4.32 Stange Pick NOT

APPROVED

6 0.03 0.08 0.24 0.11 0.01 0 0 74.9 Stange Pick NOT

APPROVED

7 0.15 0.04 1.61 2.42 0.02 0.08 0.01 MI NOT

APPROVED

8 0.41 0.06 0.83 0.01 0.09 0.06 0.01 161.46 ATYPICAL

APPROVED

9 0.502 0.175 0.297 0.254 0.344 0.014 0.005 124.85 NOT

APPROVED

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

Neville Winter X

Cromatographic Profile Yellow No. 5

Standard

Market

Sample

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

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

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 water

0.5 % máx. 0.32% 0.51% 0.39%

Lead as Pb 10.0 ppm max. 17.4 8.5 16.3

Arsenic as Ar 1.0 ppm max. 1.8 1.3 1.7 Cadmium 1.0 ppm max. 0.02 0.01 0.02

Iron 200 ppm max <100 <100 <100 Mercury 1.0 ppm max. <0.005 <0.001 0.01 Copper Unspecified 246 295 291

Antimony 2.0 ppm max. 1.59 0.23 1.06

Dispersability Positive Positive Positive Positive Volatile organic

impurities Pass Pass Pass Pass

Total count 1,000 UFC/g Máx <10 <10 <10

Coliforms 10 UFC/g Máx. <10 <10 <10

Mould and Yeast 100 UFC/g Máx. <10 <10 <10

E. Coli Negative Negative Negative Negative

Salmonella Negative Negative Negative Negative

¿What is Sensient Colors doing on this mattter?

Implemented an exhausitive monitoring of raw materials and

finished products, batch per batch using the most sensitive

equipment in the market ICP-MS

Pesticides

Pesticidas

Aplica a Colores Naturales (Ej. Cúrcuma y Paprika)

A pesticide is any substance made to control, kill, repel or attract pests. Such pest may be any living organism that causes damage or economic loss or to forward or produce disease.

Pesticide Residues

• Botanical natural color sources carry pesticide risk

• Pesticide residues can be concentrated during the extraction process to much higher levels than might present in a food crops.

• Compliance to EPA, Codex and EU pesticide residue regulations.

• The full list will number over 300 different pesticide types

• For colors from natural sources, a concentration factor based on coloring units, is applied similar to spice extracts.

• Every batch of the botanical product should be tested

Adulteration

Illegal Colors Apply to Synthetic and Natural Colors

Illegal Dye CAS Number

Bixin & Norbixin 6983-79-5 & 542-40-5

Sudan I 842-07-9

Sudan II 3118-97-6

Sudan III 85-86-9

Sudan IV 85-83-6

Sudan Red B 3176-79-2

Sudan Orange G 2051-85-6

Sudan Red 7B 6368-72-5

Sudan Red G 1229-55-6

Sudan Black B 4197-25-5

Para Red 6410-10-2

Butter Yellow 60-11-7

Rhodamine B 81-88-9

Orange II 633-96-5

Toluidine Red 2425-85-6

Acid Yellow 36 ( Metanil Yellow) 587-98-4

Oil Orange SS 2646-17-5

Auramine O 492-80-8

p- Nitroaniline 100-01-06

Fast Garner GBC 97-56-3

Adulteration

Purple Blue Green Yellow Orange Red Blue 2 Blue 1 Green 3 Yellow 5 Yellow 6 Red 40 Rhodamine B Patent Blue V B1 + Y5 Metamil Yellow Orange II Red 3 Green S Dimethyl Yellow Sudan Orange Para Red Fast Garnet GBC Oil Orange SS Sudan Red 7B Auramine Sudan I & II Ponceau 4R Quinoline Yellow p-Nitroaniline Carmoisine Chrysoidine G Sudan III Sudan IV Amaranth Toluidine Red

Adulteration

Residual Solvents

Solvent Residues United States (ppm) European Union (ppm) Japan Korea (ppm)

Acetone 30 50 30 50

1, 3 –Butylene glycol MA -- -- --

Ethyl acetate MA 50 -- --

Ethyl chloride 30 -- -- --

Isopropyl alcohol 50 50 50 30-50

Methyl alcohol 50 50 50 50

Methylene chloride 30 10 -- 10-30

Hexane 25 50 25 25

Trichloroethylene 30 -- 30 --

n-Butanol -- 50 -- --

Methyl ethyl ketone -- 50 -- --

Ethyl alcohol -- 50 --

Trichloro ethylene -- -- 30 30

Supplier Reliability and Raw Material Traceability

Supplier Reliability

• New supplier or raw material approval process is HACCP based

• Approvals done for each specific manufacturing site

• Hazard analysis on raw materials at the approval step

• Criteria established for rating raw materials “Quality Critical” (IPEC)

• Third party audits at these “Quality Critical” raw material suppliers

• Development of screening tools for potential adulterants

CONFIDENTIAL 47

Third party testing Protocol

• Food plants should meet GFSI requirements

• State-of-the-art GMP manufacturing in all facilities

• HACCP, GMP’s and internal audits should be available.

• IPEC guidelines (stringent pharmaceutical cGMP requirements)

• National organic program

CONFIDENTIAL 48

Benefits for Establishing Standards