食品グレードの基準への準拠が重要な理由
コンベアベルトから包装フィルムに至るまで、食品と接触するすべてのプラスチック部品は、法的拘束力のある安全基準に準拠しなければなりません。これらの要件を満たさない場合、製品の回収、規制当局による罰金、および重大な法的責任のリスクが生じる可能性があります。本ガイドでは、主要な2つの規制枠組みについて解説します： FDA 21 CFR 米国では、そして EU規則第10/2011号 欧州連合（EU）における要件に加え、材料選定、移行試験、およびサプライヤーの文書に関する実践的なガイダンスも含まれています。.
規制の枠組み：FDA 21 CFR 対 EU 10/2011
について FDA 21 CFR （連邦規則集第21編）は、米国における食品接触物質を規定しています。 主な条項には、21 CFR 175（接着剤およびコーティング剤）、21 CFR 177（ポリマー）、および21 CFR 178（添加剤および製造補助剤）が含まれます。 FDAは、承認済み物質のポジティブリストを管理するとともに、新規材料を対象とした食品接触物質届出（FCN）プログラムを運営しています。.
EU規則第10/2011号 食品と接触することを意図したプラスチック材料および製品に関する規則は、EU加盟国全体で統一された枠組みを定めています。この規則では、総移行限界（OML）を 10 mg/dm², 、個々の物質に対する特定移行限度（SML）、および認可されたモノマー、添加剤、ポリマー製造助剤のEUリスト。適合性は、実際の使用状況を模擬した標準化された条件下での移行試験を通じて実証される。.
この2つの制度は理念が異なります。FDAは 完成品の安全性, 一方、EUは次のように強調している 構成上の適合性 — 製造に使用されるすべての物質は、承認リストに記載されているものでなければならない。.
食品接触用として認可されたプラスチック
以下の表は、食品用途で一般的に使用されるエンジニアリングプラスチック、それらの最高使用温度、および食品加工・包装分野における代表的な用途をまとめたものです。
| 素材 | 最高温度（°C） | 食品との接触における代表的な用途 |
|---|---|---|
| PP（ポリプロピレン） | 100 | 包装用フィルム、容器、キャップ、電子レンジ対応食器 |
| HDPE（高密度ポリエチレン） | 90 | ミルクジャグ、まな板、食品保存容器、配管 |
| PET（ポリエチレンテレフタレート） | 70 | 飲料ボトル、クラムシェル型パッケージ、オーブン対応トレイ |
| PA6 / PA66（ナイロン） | 120-150 | コンベヤ部品、食肉加工用部品、歯車、ブッシュ |
| POM（アセタール／デルリン） | 100 | 充填機の部品、バルブシート、コーヒーマシンの部品 |
| PPSU（ポリフェニルスルホン） | 180 | 哺乳瓶、医療用および外食産業用トレイ、高温充填用途 |
| PEEK（ポリエーテルエーテルケトン） | 260 | 高温処理、製パン用オーブン、殺菌装置 |
材料の選定は、単に化学組成の問題だけではありません。そのグレードは、 特別に配合された 食品との接触を目的とする場合は、認可された添加物のみを、許容濃度内で使用すること。例えば、工業用グレードのPA6には、EU規則10/2011やFDA 21 CFRで許可されていない潤滑剤や熱安定剤が含まれている場合がある。.
移行テスト：何が移行されるかを測定する
移行試験は、管理された条件下で、プラスチックから食品または食品模擬物質へ移行する物質の量を定量的に測定するものです。この 総移行限界値：10 mg/dm² （飼料1kgあたり約60mg）という基準は、試験条件は異なるものの、FDAとEUの両方の枠組みに共通して適用される。.
EU 10/2011では、食品の種類に応じた食品模擬物質が規定されています：
| シミュラント | を表す | 例 |
|---|---|---|
| 試験物質A：10% エタノール | 水分を多く含む食品 | 水、飲み物、スープ |
| 試料B：3% 酢酸 | 酸性の食品（pH < 4.5） | 酢、柑橘類の果汁、ピクルス |
| 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.
よくある質問
FDAとEUの食品接触規制の主な違いは何ですか？
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（ナイロン6）は、食品と直接接触する用途に使用できますか？
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.
プラスチックのサプライヤーには、どのような資料を依頼すべきでしょうか？
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 または FCN reference number, along with supporting test data. Additionally, request migration test reports, formulation disclosure statements, そして ISO 9001 or FSSC 22000 certification as evidence of quality management systems.
食品グレードの適合性について、どのくらいの頻度で再認証を受けるべきですか？
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.
