식품 등급 규격 준수가 중요한 이유
컨베이어 벨트부터 포장 필름에 이르기까지 식품과 접촉하는 모든 플라스틱 부품은 법적 구속력을 지닌 안전 기준을 준수해야 합니다. 이러한 요건을 충족하지 못할 경우 제품 리콜, 규제 당국의 과태료 부과, 심각한 법적 책임에 직면할 수 있습니다. 이 가이드에서는 두 가지 주요 규제 체계를 다룹니다: FDA 21 CFR 미국에서 그리고 EU 규정 제10/2011호 유럽연합(EU) 내에서의 규정과 더불어, 재료 선정, 이온 이동 시험 및 공급업체 관련 서류에 대한 실질적인 지침도 포함되어 있습니다.
규제 체계: FDA 21 CFR 대 EU 10/2011
그리고 FDA 21 CFR (연방규정집 제21편)은 미국 내 식품 접촉 물질을 규제합니다. 주요 조항으로는 21 CFR 175(접착제 및 코팅제), 21 CFR 177(고분자), 21 CFR 178(보조제 및 제조 보조제) 등이 있습니다. FDA는 승인된 물질의 허용 목록을 관리하고 있으며, 신규 물질에 대해서는 식품 접촉 물질 신고(FCN) 프로그램을 운영하고 있습니다.
EU 규정 제10/2011호 식품과 접촉하도록 의도된 플라스틱 재료 및 제품에 관한 이 규정은 EU 회원국 전반에 걸쳐 통일된 체계를 마련합니다. 이 규정은 총 용출 한도(OML)를 10 mg/dm², 개별 물질에 대한 특정 이온 이동 한계치(SML) 및 승인된 단량체, 첨가제, 고분자 제조 보조제에 대한 연합 목록. 규정 준수 여부는 실제 사용 환경을 모사한 표준화된 조건 하에서 실시하는 이온 이동 시험을 통해 입증됩니다.
두 시스템은 철학적으로 차이가 있는데, FDA는 완제품의 안전성, 반면 EU는 다음과 같이 강조하고 있다 구성적 준수 — 제조에 사용되는 모든 물질은 승인된 목록에 포함되어야 합니다.
식품 접촉용으로 승인된 플라스틱
다음 표는 일반적으로 사용되는 식품용 엔지니어링 플라스틱, 해당 플라스틱의 최대 사용 온도, 그리고 식품 가공 및 포장 분야에서 주로 적용되는 용도를 요약한 것입니다:
| 재료 | 최대 온도 (°C) | 일반적인 식품 접촉 용도 |
|---|---|---|
| PP(폴리프로필렌) | 100 | 포장용 필름, 용기, 뚜껑, 전자레인지용 식기 |
| HDPE(고밀도 폴리에틸렌) | 90 | 우유 용기, 도마, 식품 보관 용기, 파이핑 |
| PET (폴리에틸렌 테레프탈레이트) | 70 | 음료 병, 클램쉘 포장, 오븐용 트레이 |
| PA6 / PA66 (나일론) | 120-150 | 컨베이어 부품, 육류 가공 부품, 기어, 부싱 |
| POM (아세탈 / 델린) | 100 | 충전 기계 부품, 밸브 시트, 커피 머신 부품 |
| PPSU (폴리페닐설폰) | 180 | 젖병, 의료용 및 식품 서비스용 트레이, 고온 충전 용도 |
| PEEK (폴리에테르 에테르 케톤) | 260 | 고온 처리, 제빵용 오븐, 살균 장비 |
재료 선정은 단순히 화학 성분만을 고려하는 것이 아닙니다. 등급은 반드시 특별히 고안된 식품 접촉용으로는 승인된 첨가물만을 허용된 농도로 사용해야 합니다. 예를 들어, 산업용 PA6에는 EU 10/2011 또는 FDA 21 CFR에서 허용되지 않는 윤활제나 열안정제가 포함되어 있을 수 있습니다.
마이그레이션 테스트: 이전되는 항목 측정
이동성 시험은 통제된 조건 하에서 플라스틱에서 식품 또는 식품 모사체로 이동하는 물질의 양을 정량적으로 측정합니다. 이 10 mg/dm²의 총 이동 한계치 (사료 1kg당 약 60mg)은 시험 조건은 다르지만 FDA와 EU 규정 모두에 적용됩니다.
EU 10/2011은 식품 유형에 따라 식품 모의 물질을 다음과 같이 규정하고 있습니다:
| 모의 대상 | ~를 나타낸다 | 예제 |
|---|---|---|
| 시뮬란트 A: 10% 에탄올 | 수분 함량이 높은 식품 | 물, 음료, 수프 |
| 모의 시료 B: 3% 아세트산 | 산성 식품 (pH < 4.5) | 식초, 감귤류 주스, 피클 |
| Simulant C: 20% Ethanol | Alcoholic foods (up to 20%) | Wine, beer, sauces with alcohol |
| Simulant D1: 50% Ethanol | Fatty foods (alternative) | Oils, butter, fried foods |
| Simulant D2: Vegetable Oil | Fatty foods (reference) | Cooking oils, fatty meat, cheese |
| Simulant E: Tenax (MPPO) | Dry foods | Flour, cereals, dried fruit |
Specific migration limits (SMLs) apply to individual substances. For example, primary aromatic amines (PAAs) — potential degradation products from polyurethane and certain colorants — are restricted to a detection limit of 0.01 mg/kg. Each substance on the Union List has its own SML, and compliance must be demonstrated for every authorized substance present in the material.
“Food Grade” Means Full Supply Chain Compliance
A common misconception is that “food grade” is a property of the raw material alone. In reality, food-grade compliance spans the entire supply chain:
- Raw material production: The polymer resin must be manufactured using only authorized monomers and additives listed in the applicable positive list.
- Compounding and coloring: Any masterbatch, pigment, or filler introduced during compounding must itself be food-contact approved. A non-compliant colorant can invalidate the entire batch.
- Processing and machining: Contamination risks arise from mold release agents, cutting fluids, and lubricants used during fabrication. Dedicated food-grade production lines or thorough cleaning protocols are essential.
- Storage and transport: Finished parts must be stored and shipped in conditions that prevent contamination from dust, chemicals, or cross-contact with non-food-grade products.
- End-use conditions: The manufacturer’s declaration of compliance is valid only for the tested conditions — if a part is used at higher temperature or with more aggressive foods than tested, compliance may be voided.
Supplier documentation must demonstrate traceability at every stage. A Declaration of Compliance (DoC) under EU 10/2011 requires identifying the material, confirming migration test results, and specifying any restrictions on use.
NSF Certification: An Additional Layer
NSF International (formerly the National Sanitation Foundation) provides third-party certification for materials used in commercial food equipment. NSF/ANSI Standard 51 covers plastic materials and components used in food zone applications. Certification involves:
- Formulation review against the NSF-approved ingredient list
- Migration testing under NSF-specified conditions
- Annual unannounced facility audits to verify ongoing compliance
NSF certification is not a substitute for FDA or EU compliance — it is an additional, voluntary certification commonly required by equipment manufacturers and end users in North American food service. Many global food equipment brands require NSF-listed materials as a procurement condition.
Common Compliance Mistakes
Experience shows several recurring errors in food-grade plastics sourcing and specification:
- Using recycled material without certification: Post-consumer recycled (PCR) plastics require a formal FDA Letter of No Objection or EFSA opinion confirming the recycling process produces food-grade material. Uncertified recycled content is not food-contact compliant, regardless of the original material grade.
- Wrong or undocumented additives: Heat stabilizers, UV stabilizers, nucleating agents, and processing aids must all be food-contact approved. Using an industrial-grade additive instead of its food-grade counterpart is one of the most frequent causes of compliance failure.
- Silicone contamination from lubricants and mold release: Silicone-based mold release agents and lubricants can migrate into food. Only food-grade silicone products should be used in production, and residual levels must be verified.
- Assuming equivalence across regions: A material approved under FDA 21 CFR is not automatically compliant with EU 10/2011 (and vice versa). The positive lists differ, and SMLs may vary significantly between jurisdictions.
- Incomplete supplier documentation: A material data sheet alone is insufficient. Full compliance requires traceable documentation including DoC, migration test reports, and evidence of audit trail through the supply chain.
자주 묻는 질문
FDA와 EU의 식품 접촉 관련 규정 간에 어떤 주요 차이점이 있나요?
The FDA system is risk-based and evaluates the safety of the finished article in its intended use. Substances not covered by an existing regulation can be submitted through the Food Contact Notification (FCN) process, which is confidential to the notifier. The EU system is substance-based: every monomer, additive, and production aid must appear on the Union List with a defined SML. The EU also mandates a written Declaration of Compliance for each material. In practice, EU compliance is generally more prescriptive and documentation-intensive, while FDA compliance allows more flexibility through the FCN pathway. For products sold in both markets, dual compliance must be verified independently.
PA6(나일론 6)을 식품과 직접 접촉하는 용도로 사용할 수 있습니까?
Yes, PA6 is widely used in food contact applications — but only when produced using approved monomers (caprolactam) and additives. Caprolactam has an SML of 15 mg/kg under EU 10/2011. The material must be tested to confirm caprolactam migration stays below this limit. PA6 is commonly found in meat processing equipment, conveyor components, coffee machine parts, and kitchen utensils. The key requirement is that the specific grade be formulated and documented for food contact use — an uncertified industrial PA6 grade is not suitable, even if the base polymer is chemically identical.
플라스틱 공급업체에 어떤 서류를 요청해야 할까요?
For EU compliance, request a Declaration of Compliance (DoC) per EU 10/2011 Article 15, which must include: (1) identity of the manufacturer/importer, (2) identity of the material/article, (3) date of declaration, (4) confirmation of compliance with applicable regulations, (5) information on substances subject to SMLs or restrictions, (6) adequate information on restricted-use substances, (7) specification of use conditions (food types, time, temperature), and (8) the overall migration ratio when a functional barrier is used. For FDA compliance, request a letter of compliance 또는 FCN reference number, along with supporting test data. Additionally, request migration test reports, formulation disclosure statements, 및 ISO 9001 or FSSC 22000 certification as evidence of quality management systems.
식품 등급 적합성 인증은 얼마나 자주 갱신해야 합니까?
There is no fixed recertification interval in either FDA or EU regulations. However, best practice recommends: (1) Annual DoC renewal — suppliers should reissue declarations at least yearly to confirm no formulation changes have occurred. (2) Re-certification upon any change — any modification to raw materials, additives, processing conditions, or the supplier of a critical input requires new migration testing and updated documentation. (3) Periodic surveillance testing — many end users conduct annual migration spot-tests as part of their supplier quality program. (4) NSF-listed materials are subject to annual unannounced audits and re-certification. In practice, large food companies often require their suppliers to confirm compliance annually as a contractual condition, even if the regulations do not explicitly mandate it.
Making Confident Material Choices
Food-grade compliance is ultimately about documented, verifiable safety. The most technically suitable plastic is useless if its compliance pedigree cannot be demonstrated. When specifying materials, insist on full documentation covering formulation, migration testing, and supply chain traceability. The cost of compliance is insignificant compared to the cost of a recall.
