4 Food Laws and Regulations

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    Food Laws and Regulations

    2015

    Mata Kuliah

    Sanitasi Industri Perikanan

    © Bayu Kusuma, S.Pi, M.ScTeknologi Hasil PerikananFakultas Perikanan dan Ilmu KelautanUniversitas Brawijaya

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    Buku bahan ajar• Troller, J.A. 1983. Sanitation in Food Processing.

    Academic Press: New York.

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    Daftar Isi

    Impact of Regulation

    Enforcement

    Law

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    History• Pada masa yang lalu, konsumen akan dengan mudahnya

    merasa puas dengan makanan yang terlihat aman sertaberbau dan berasa enak.

    • Sekarang, konsumen mengetahui bahwa banyak komponenyang berbahaya efeknya bagi kesehatan sehingga trust darikonsumen membutuhkan sebuah law dan regulation .

    • Banyak organisasi yang mengatur regulasi dan hukum tentangpangan didirikan guna perlindungan konsumen seperti FDA,WHO, dsb.

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    The Federal Food, Drug, and Cosmetic Act of 1938

    • It contains added poisonous or added deleterious substancesthat may render it injurious to health.

    • It bears or contains any added poisonous or added deleterioussubstance that is unsafe.

    • It consists in whole, or in part, of any filthy, putrid, ordecomposed substance, or if it is otherwise unfit for food.

    • It has been prepared, packed or held under unsanitaryconditions whereby it may have become contaminated with

    filth or whereby it may have been rendered injurious tohealth.

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    TIME TO THINK ANDDISCUSS

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    FDA Inspectors1. Present credentials to appropriate company officials.

    2. Provide written notice of inspection [Form 482].

    3. After the inspection has been completed, a written statementcovering any violative conditions [Form 483] must be

    presented to the offending company.

    4. Receipts [Form 484] must be furnished for any samplesobtained. Samples must be paid for by the FDA.

    5. In some cases, such as low-acid canned foods, a writtenrequest for certain records may be used.

    6. In similar instances to number 5, a written request forinformation on procedures and processes also may besubmitted.

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    Outcome Inspections1. Nothing. Your plant is picture-book perfect or the inspector

    missed a few little "problems" that you were holding yourbreath over.

    2. Regulatory letter informing you of unsatisfactory conditionsand requesting appropriate corrections.

    3. Reinspection within some designated period of time.4. Seizure of adulterated or misbranded products.

    5. Hearing on possible criminal proceedings.

    6. Recall.

    7. Criminal prosecution.

    8. Federal court order prohibiting violative acts.

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    Notice of Adverse Findings• Surat informasi mengenai kecurigaan terhadap kondisi atau

    produk yang melanggar hukum dalam sebuah industrimakanan.

    • Kriteria dikeluarkannya Notice of Adverse Findings adalah:1. Violation of the law has occurred or there is evidence that an existing

    practice may lead to a violation if not corrected.2. The history of the case indicates that there is a likelihood of prompt

    and complete correction.

    3. The agency has elected to request voluntary action and has not madea final decision to seek formal administrative or judicial relief if a

    correction is not effected.

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    Market Recoveries• Stock recovery.• Market withdrawal.• Recalls. Types issue for recalls:

    1. Class I. There is a reasonable expectation that use of or exposure to aviolative product will cause serious health risks or death.

    2. Class II. Use of or exposure to a violative product may causetemporary or medically reversible adverse health consequences, orthe probability of serious, adverse health consequences is remote.

    3. Class III. A situation in which use of or exposure to a violative productis not likely to cause adverse health consequences.

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    TIME TO THINK ANDDISCUSS

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    Exports and Imports Regulations

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    Food Defect Action Levels 1

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    Food Defect Action Levels 2

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    Impact of Regulation

    • Cost• Safety• Effect on product development. Consideration on product

    development:1. What the product is to be. Is a common name for it established?

    2. Ingredients —dietary considerations and definition of standard3. Ingredients. Amounts of ingredients. Are they restricted?

    4. Size of marketing unit. Identify reasonable serving portions and their proportion of the recommended daily allowance.

    5. Consumer concept of the product. Is it represented honestly?

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    GMP (Good Manufacturing Practices)

    • The GMP regulations were established in 1969 to define in

    clearer terms what the FDA expects from food plants thatmeet the provision of the Food Drug and Cosmetic Act of1938, which essentially states that a food is consideredadulterated if it has been packed, held, or prepared under

    conditions in which it might have become contaminated.• The GMPs are an attempt to delineate what these conditions

    are and as such, are an aid to industry by directing attentiontoward what the FDA looks for with regard to sanitation.

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    TIME TO THINK ANDDISCUSS

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    TERIMA KASIH