Flavors & Fragrances Quality and Regulatory



It's simple; you need a partner you can trust.

From a comprehensive vendor approval process, to the testing of raw material at receipt as well as when product is ready to be shipped; we prove our dedication to supply chain transparency, every day.

Our product documentation and certifications ensure the integrity of our product through all steps of the supply chain, including 'third party' auditing. Quality management is critical for us because it is critical for your formulations.

The matrix below provides a quick reference for how Sigma-Aldrich meets and exceeds your quality and regulatory needs. Click on any column header for further explanations and definitions related to that quality requirement.

 

– Required & Fulfilled by Sigma-Aldrich
– Fulfilled by Sigma-Aldrich
Quality Grade
   Food Safe Elite Food Grade (FG) Natural
(EU or US)
Kosher or Halal IFRA
Quality Systems
FDA Registered Facility1
Food GMP Packaging (21CFR110)2
HACCP (21CFR120, EC 852/2004)
HARPC (21CFR117)
Manufactured according to US Food Regulations (21CFR117 and/or FCC) Where Applicable Where Applicable N/A
Manufactured according to EU Food & Hygiene Regulations (EC 178/2002 and EC 852/2004) Where Applicable Where Applicable N/A
Continuing Guarantee (21CFR117 / EC 1334/2008 / EU Regulation 1223/2009)3
Expiration Date (EC 1334/2008) Where Applicable Where Applicable Where Applicable
EU Natural(EC 1334/2008) and US Natural (21CFR101) Where Applicable Where Applicable Where Applicable
Meets requirements of EC 872/2012 flavoring substances list.   Where Applicable Where Applicable N/A
GMO Validation (7CFR205 / EC 1829/2003 and EC 1830/2003)3
Specifications / Testing
Additives identified (EC 1334/2008, 7CFR205)
Allergens Identified (EC 1829/2003 & EC 1830/2003)
Heavy Metals  (88/388/EEC) (≤3 ppm As, ≤10 ppm Pb, ≤1 ppm Cd, ≤1 ppm Hg)
Residual Solvents ( 2009/32/EC) Where Applicable Where Applicable Where Applicable Where Applicable
Isotopic testing for natural validation Where Applicable Where Applicable Where Applicable Where Applicable
Documentation
Allergen Statements (2003/15/EC)4
IFRA Guidelines (EU Regulation 1223/2009 and IFRA Standards) Where Applicable Where Applicable Where Applicable Where Applicable
BSE/TSE Declaration
Certificates of Analysis
Specification Sheets
MSDS / SDS
Country of Origin
CITES and FWS Compliance5 Upon Request Upon Request Upon Request Upon Request Upon Request
Food Grade statement (21 CFR 117 and EU 178/2002) Where Applicable Where Applicable Where Applicable
Regulatory statement
Natural statement (21 CFR 101.22 and/or EC 1334/2008) Where Applicable Where Applicable Where Applicable
Manufacturing Flow Chart Upon Request Upon Request Upon Request Upon Request
Kosher or Halal Certificate  Where Applicable Where Applicable Where Applicable

1 Required for import/export.
2 cGMP as defined by 21CFR110 relating specifically to food.
3 Indicates product is unadulterated.
4 Any allergens present must be declared, if no allergens are present a statement is not required
5 Guidelines on protecting endagered species.  See cites.org and fws.gov

Quality Management Systems
Learn more about our quality systems and processes.

Safety & Regulatory Systems
Find safety documents and learn more about Sigma-Aldrich.

Ask an Expert
Have a quality or regulatory question? We have our in house Quality Assurance expert to answer all your questions.

Food Safe Elite - All the quality and compliance you have come to trust with some added features. Sigma-Aldrich's food safe elite ingredients include vendor auditing, compliance to food grade requirements and all of the regulatory documentation you need including manufacturing process diagrams.


Food Grade (FG) - This referrs to Sigma-Aldrich products that are manufactured in full compliance with US Good Manufacturing Practice for Food (21 CFR 117) and EU General Food Law (EU 178/2002).  To learn more about our Food Grade Supply Chain click here.


Natural – Products that meet the EU natural flavorings designation (EC 1334/2008 art. 3, § 2 ) and US natural flavor designation (Title 21 Code of Federal Regulation (CFR) 101.22(a)(3) ). Products designated  Natural (US) meet only the natural flavor designation (Title 21 Code of Federal Regulation (CFR) 101.22(a)(3) ).  To learn more about the natural ingredient regulations click here.


Halal - Products are certified to meet halal requirements. The meaning of Halal in foods, beverages or ingredients for food or beverages refers to the  permissibility of those ingredients for consumption by Muslims under Islamic Shariʻah (law). The criteria specifies both what foods are allowed, and how the food must be prepared. The foods addressed are mostly types of meat and animal tissue. For a list of our Halal ingredients click here


Kosher - Products that are certified Kosher Parve. Kosher certified refers to food and ingredients that conform to the regulations of Jewish dietary law. To learn more about our Kosher certification click here


Nature Identical (NI) – Products made by chemical synthesis or isolated by chemical processes and are chemically identical to a substance naturally present in vegetable or animal origin materials as described in EU regulation 88/388/EEC.  Regulation EC 1334/2008 supersedes 88/388/EC and the current EU regulation (EC 1334/2008) makes no distinction for NI materials. Therefore, these materials are now considered artificial or synthetic.


IFRA – Products meeting the guidelines for fragrances as designated by IFRA (the International Fragrance Association). 


REACH - Products meeting the EU REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) requirements. REACH aims to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances.


HACCP - HACCP or Hazard Analysis Critical Control Point is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.


FSSC 22000 - The Food Safety Management System (FSSC) provides a framework for effectively managing your organization's food safety responsibilities. FSSC 22000 is fully recognized by the Global Food Safety Initiative (GFSI) and is based on existing ISO Standards (ISO 22000). To learn more click here


FSMA - The FDA Food Safety Modernization Act (FSMA), aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. To learn more click here

 

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