Comparison of LFGB and FDA Silicone Materials
Are you a brand owner, retailer, importer, or e-commerce brand? Have you ever tried to send your food storage products outside the country? Germany wants it to have LFGB certification, while America stamps the passport with the FDA approval before letting the products through customs.
They both are saying ‘Safe for food’ , just in different languages – one in exact German, the other in American legalese. But the people in the customs department want the product approval certification in their own regulatory language.
Understanding the difference between LFGB and FDA and how the system works with them is crucial for any brand. As an expert in the silicone industry, today, we’ll be doing a comprehensive comparison between LFGB and FDA to save you a thousand dollars in testing costs. And also, some unnecessary headache on the border.
Comparison of LFGB vs. FDA Silicone
|
Feature |
LFGB Silicone |
FDA Silicone |
|---|---|---|
|
Country of Regulation |
Germany (EU) |
United States |
|
Regulatory Body |
BfR (Federal Institute for Risk Assessment) |
FDA (U.S. Food and Drug Administration) |
|
Legal Framework |
Lebensmittel-, Bedarfsgegenstände- und Futtermittelgesetzbuch (LFGB) |
Food, Drug, and Cosmetic Act (FD&C Act) |
|
Standard Code |
BfR Recommendation XV for Silicone |
21 CFR 177.2600 |
|
Product Type |
Food-contact silicone |
Food-contact silicone |
Legal and Regulatory Framework
LFGB (Germany / EU)
LFGB is the German Food and Feed Code, aligned with EU Regulation (EC) No. 1935/2004. Silicone materials must comply with BfR Recommendation XV, which outlines allowable substances, migration limits, and testing procedures. LFGB is known for its stricter and more comprehensive testing, especially regarding sensory neutrality.
FDA (U.S.)
The FDA regulates food-contact materials under Title 21 CFR Part 177, specifically §177.2600 for rubber articles intended for repeated use. FDA compliance is based on the list of permitted ingredients, extraction limits, and intended use conditions (temperature, duration of contact, etc.)
Testing Requirements and Limits
FDA Silicone Testing (21 CFR 177.2600)
Extraction Tests: Determines the amount of extractable substances in food simulants (e.g., distilled water, n-hexane, ethanol).
Limits:
Total extractives must not exceed:
20 mg/in² (1st extraction)
1 mg/in² (2nd extraction)
Conditions: Tests performed at elevated temperatures (e.g., 40–70°C) to simulate use. Only approved ingredients and additives listed in FDA regulations are allowed.
LFGB Silicone Testing (BfR XV)
Total Migration Test: Measures the total amount of substances that migrate into food simulants.
Limits:
10 mg/dm² maximum total migration (EU standard)
Sensory Test (Organoleptic Test):
Products must not alter the taste or smell of food.
This is not required under FDA regulations.
Specific Migration Limits (SMLs): Some substances have individual limits (e.g., platinum catalysts).
Sensory Testing (Unique to LFGB)
LFGB includes sensory evaluation, where trained testers assess if the material imparts any smell or taste to food or simulants. This is a critical requirement for baby products in the EU. (FDA does not require sensory testing.)
Composition and Material Restrictions
|
Feature |
LFGB Silicone |
FDA Silicone |
|
Additives |
Must meet BfR XV criteria |
Must be on FDA’s approved list |
|
Catalysts |
Platinum-based preferred; residue limits apply |
Allowed, but must meet extractive limits |
|
Fillers |
Must be food-safe and not migrate |
Allowed if compliant with extraction limits |
Compliance Documentation
|
Requirement |
LFGB |
FDA |
|
Declaration of Compliance (DoC) |
Required under EU 10/2011 and LFGB |
Recommended but not mandatory |
|
Testing Report Validity |
Must comply with specific BfR test methods |
Must demonstrate compliance with §177.2600 |
|
Traceability |
Required under EU regulations |
Recommended under FDA GMP |
Market Implications
|
Criteria |
LFGB Silicone |
FDA Silicone |
|
Market Scope |
Germany, EU, global (preferred in premium markets) |
USA, Canada, some global markets |
|
Acceptance |
Often accepted globally due to stricter criteria |
Accepted in the U.S. and many other countries |
|
Cost |
Typically higher due to stricter compliance |
Lower testing and material costs |
Visual and Physical Differences
|
Attribute |
LFGB Silicone |
FDA Silicone |
|
Transparency |
Often clearer and purer |
May appear slightly cloudy depending on fillers |
|
Odor |
Odorless (due to sensory testing) |
May retain slight odor if not fully cured |
|
Durability |
High (pure silicone, fewer fillers) |
High, but may vary with composition |
Suitability for Baby Products
|
Feature |
LFGB Silicone |
FDA Silicone |
|
Chemical Safety |
✔️Excellent |
✔️Very Good |
|
Sensory Neutrality |
✔️Required |
❌Not required |
|
BPA-Free |
✔️Yes |
✔️Yes |
|
Dishwasher/Microwave Safe |
✔️Yes |
✔️Yes |
|
Baby Market Preference |
Preferred in EU and premium brands |
Common in U.S. and entry-level markets |
Summary Table
|
Feature |
LFGB Silicone |
FDA Silicone |
|
Regulatory Body |
BfR (Germany) |
FDA (USA) |
|
Main Standard |
BfR Recommendation XV |
21 CFR 177.2600 |
|
Migration Limit |
10 mg/dm² |
20/1 mg/in² |
|
Sensory Testing |
Required |
Not required |
|
Additive Restrictions |
Stricter |
More flexible |
|
Compliance Documentation |
Mandatory DoC |
Not mandatory |
|
Typical Applications |
U baby products, premium kitchenware |
U.S. market products, utensils |
|
Cost |
Higher |
Moderate |
|
Global Acceptance |
Widely accepted |
Region-specific |
Conclusion
LFGB silicone is generally held to stricter standards than FDA silicone — particularly due to the sensory (organoleptic) testing and tighter migration limits.
If you’re manufacturing or selling baby products, premium kitchenware, or items for the EU, LFGB compliance is highly recommended or required.
FDA-compliant silicone is suitable for products intended for the U.S. market and provides a cost-effective solution with good safety standards, though it may not meet the stricter expectations of some global buyers.
