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宠物食品的管理法规--美国

  • : 2013-03-06 11:20:14
  • : 49955

FDA(美国食品及药物管理局宠物食品法规)    FDA's Regulation of Pet Food

  在此法案中“药品”在某种程度上是:旨在用来诊断、治愈、减缓、治疗或者预防某种疾病,或者旨在区别于食品来讲对身体的某部分构造起到一定作用的用品。 (Sec. 201 (g)(1)) 在药物学法案定义中,法院已对“食品”进行解释:用以提供营养、滋味或者芳香的物品。如果食品影响着身体某部分结构,其也必须具备此类功能(如:某种食品可供给营养物质比如钙,会对骨骼结构产生影响;亦或者牛磺酸会对猫科动物的心脏健康有益等)。但是,如果某种物质不仅影响了身体部分构造或者功能,而且其影响远超出它自身的营养功效,比如能使尿液酸化或者提高关节的功能等,那其物质就应该被视为一种药物。(药物)对身体结构、功能的影响效应远超出“食品”的范围,但是同时也应要求(药物)的生产及功效应用于改变或提高(身体某部分)的功能。

  In the Act a "drug" is, in part, an article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, or an article intended to affect the structure or function of the body other than food (Sec. 201 (g)(1)). In the drug definition, the courts have interpreted "food" as something that provides nutrition, taste, or aroma. If a food affects the structure or function of the body, it does so by these properties (for example, a food may provide nutrients such as calcium for proper bone structure or taurine for healthy heart function in cats). However, if a substance affects the structure or function of the body apart from its nutritive value, such as urine acidification or improvement in joint function, it may be considered a drug. Structure、function effects extending beyond the "food" umbrella also include claims for improved or increased production and performance, or alteration or improvement in function.

  当一种物质包含一种被认为是食物的物质,但其旨在用于治疗或预防某种疾病或者其物质本身为“非食品”的结构、功效的,FDA视其为一种药物。在联邦法律定义下,一种新的动物药物必须被证明安全且有足够充分的数据证明其符合新型动物药物应用法案(21 CFR, Part 514)的相关规定。如果一种上市产品并没有得到核准,其应该被视为一种劣质药物并被我局监管。

  When a substance, including one considered food, is intended to be used for the treatment or prevention of disease or "non-food" structure、function effect, FDA considers it a drug. Under the law, a new animal drug must be shown to be safe and effective for its intended use by adequate data from controlled scientific studies as part of a New Animal Drug Application (21 CFR, Part 514). If a product on the market is not approved, it may be deemed an adulterated drug and subject to regulatory action.

  在1958年,旨在回应公众对日益增加的食品及食品生产过程中的化学添加剂的担心,国会修改了法案以要求(食品)在入市前预检中应明确列出不被大众所熟知的添加剂成分,并规定如果某种食品包含了不被批准的食品添加剂,将被视为不安全食品。在此法案的Sec.201(s)中对食品添加剂的定义为:所添加的物质须为一般认为安全的(GRAS),如所添加物质非“食品添加剂”则应豁免于入市前预检手续。

  In 1958, in response to public concern about the increased use of chemicals in foods and food processing, Congress amended the Act to require the pre-marketing clearance of additives whose safety was not generally recognized. The Act was also amended to deem food unsafe and adulterated if it contains an unapproved food additive. Under the definition for food additive in Sec. 201 (s) of the Act, it provides that substances added to food that qualified scientists generally recognize as safe (GRAS) under the conditions of the intended use are not "food additives" and as such are exempt from pre-clearance approval.

  食品添加剂申请书是由FDA发展而来的一项旨在证实一种未知食品添加剂在其预期用途及实用功效上是否安全的预检机制。如果FDA通过该申请,一项相关的联邦法规(21 CFR, 573部分)食品添加剂在动物喂食及饮用水方面的许可将被相应的修改。该申请中所必要的信息如联邦法规第571部分,21篇所描述。简短说来,该申请书必须包括:对申报产品的化学属性的描述、加工流程及过程控制、分析方法、实际应用数据、人类食品级别安全数据、目标应用动物类安全数据、产品标识以及在某些特定情况下的环境评估。

  A food additive petition is the pre-clearance mechanism developed by the FDA for demonstrating that a food additive is safe for its intended use and has utility. If the FDA agrees with the petition, a regulation is published in the Federal Register and 21 CFR, Part 573, Food Additives Permitted in the Feed and Drinking Water of Animals, is amended. The information needed in a food additive petition is described in Part 571 of Title 21. Briefly, a petition contains a description of the chemical identity, manufacturing process and controls, analytical methods, utility data, human food safety data, target animal safety data, product labeling, and in some cases an environmental assessment.

  一种GRAS(一般认为安全)的物质仅在其预期目的上被认为是普遍安全的。比如:氯酸归纳在被作为一种抗凝剂时被认为是GRAS(一般认为安全)的物质,但是同时此物质据称会在凝固霉菌毒素以及在肠道吸收功能方面被认为不是一种一般认为安全的物质。一种食品也不能在其预防、治疗、减缓某种疾病时被认为是一种一般认为安全的物质。因此,硫酸软骨素在治疗关节炎时不能被认为是一种一般认为安全的物质,而应被视为一种药物。

  A GRAS substance is GRAS only for an intended purpose. For example, sodium aluminosilicate is GRAS as an anticaking agent. It has been purported to bind mycotoxins and prevent absorption from the intestinal tract but would not be GRAS for this use. A food substance also cannot be GRAS for the prevention, treatment, or mitigation of a disease. So, chondroitin sulfates cannot be GRAS to prevent or treat arthritis. For this use it would be a drug.

  在鉴别某种物质是否为一般承认的安全物质时,对其预期作用的评估鉴定是否仅依靠经过科学培训并且有经验的专家通过观察鉴别从而定义,是非常重要的。一般而言由FDA和法院解释:某种物质被定义为一般承认并且普遍认为安全前必须符合以下两个方面的要求:

  It is very important to recognize that general recognition of safety of a substance for an intended use may only be based on the views of experts qualified by scientific training and experience to evaluate the safety of the substance. As interpreted by FDA and the courts, there are two requirements that must be satisfied before a substance can be GRAS -- general recognition and safety:

  1、如果某物质被认为一般安全时,其前提必须在视为一种食物原料时被专家普遍共识为一种安全的物质;

  For general recognition, there must be an expert consensus that the substance is safe for use as a component of food, and;    

  2、专家共识该物质为安全物质的前提是:要么符合a)从1958年前的公众数据及信息中证实该物质一直被大众作为一种食品饲料所用; b)科学程序,即相同数量及质量的物质的实验数据已被FDA批准,被视为一种安全的食品添加剂。另外,该实验信息必须在大众科学期刊中发表过。

  This expert consensus of safety must be based on either (a) generally available data and information to show common use of the substance in animal feed prior to 1958 or (b) scientific procedures, which require the same quantity and quality of scientific data needed for FDA approval of the substance as a food additive. In addition, this information must be published in the scientific literature.   

  这两种要求:大众承认的和安全的,都必须基于该物质是被视为是一种GRAS(一般认为安全)的基础上。而GRAS的要求其实比单独就某种食品添加剂的审批过程要严格很多,因为被视为一种GRAS物质必须要求该物质在一定时期内以相同数量和质量的食品添加剂成分存在。此外,该物质的信息必须发表于相应的科学刊物上且被专家普遍共识为安全的物质,基于上述数据,此物质可被视为使用安全。作为公司年度报告的期刊数据不符合科学出版物的标准。为佐证大众普遍承认且安全而存在的数据,必须是刊登在相关专家认可的科学期刊上。联邦法案准许公司自行制定自己的GRAS裁定,而且很多时候GRAS板块是由相关领域的专家在对该物质的预期用途的安全性具体评估后刊登的。尽管如此,无论是FDA还是公司制定的GRAS裁定,其标准必须是一致的。

  Both of these requirements, general recognition and safety, must be met for a substance to be considered as GRAS. The GRAS standard is actually more stringent than that required for a food additive approval because for a substance to be GRAS there must exist the same quality and quantity of information needed for a food additive approval. In addition, the data must be published and there must be a consensus among qualified experts, based on the data, that the substance is safe for that use. Publication of data in a company's annual report does not meet the publication standard. For general recognition of safety to exist, the data must be available to the experts by publication in the scientific literature. The Act permits companies to make their own GRAS determination, and many times GRAS Panels will be assembled that are comprised of scientific experts in a particular field to evaluate the safety of a substance for an intended use. However, regardless of who makes the determination, the FDA or the company, the standard for GRAS is the same.

  在1997年4月17日,食品安全及营养应用中心(CFSAN)和兽医中心(CVM)共同在联邦法案(62 FR 18938)中颁布了一条告知程序法案,旨在对现有的GRAS(一般认为安全)裁定原则作出修改,代替原有的GRAS裁定原则。此告知程序中规定了,任何个人都可告知我局对某种特定用途的物质作出是否为GRAS的裁定。在告知中,须注明特定物质的以下描述:适用环境,裁定是否为GRAS物质的具体标准。我局(FDA)将不会对所提供数据的任何评估数据作出引导,因为在此物质的GRAS的申请时已经给出相关确认。当然,无论GRAS申报材料中所提供的材料是否充分,或者所提供信息是否对我局评估此物质这个议题上是否有作用,我局都会对所申报物质是否被视为一种GRAS物质这个议题上作出评估。一般我局将在90天内回复申报者。关于GRAS的通告可在我局的主页上的“摘要”一项中查看,我局同时也会回复申请者。兽医中心一般会接受已符合GRAS通告的申请,营养中心也同样。GRAS申请名单可从我局以下网站上找到:http://www.fda.gov/Food/FoodIngredientsPackaging/ GenerallyRecognizedasSafeGRAS/GRASListings/default.htm1.

     On April 17, 1997, the Center for Food Safety and Applied Nutrition (CFSAN) and CVM published a proposed rule in theFederal Register (62 FR 18938) to amend the regulations to replace the current GRAS affirmation process with a notification procedure. Under the notification procedure, any person could notify the agency of a determination that a particular use of a substance is GRAS. The notification would include a description of the substance, the conditions of use, and the basis of the GRAS determination. The FDA would not conduct its own detailed evaluation of the data, as was done previously for GRAS affirmation petitions. Rather, FDA would evaluate whether the notice provides sufficient basis for a GRAS determination and whether the information in the notification or otherwise available to FDA raises issues on whether the use of the substance is GRAS. In the proposal FDA would have 90 days to respond to the notifier. The summary of the GRAS notifications would be available on the FDA Home Page, as would the FDA's responses to the person submitting the notification. CVM is not currently accepting GRAS notifications under the proposed rule; however, CFSAN is. A listing of the notifications that have been submitted can be found on.

  一旦最终裁决被公布(关于GRAS的裁决),兽医中心(CVM)将会接受此公告结果,并且用于动物饲料添加剂物质的GRAS申请将会在兽医中心网站主页公布。当此物质通过兽医中心对其有效性的评估后,美国饲料管制协会的饲料材质主席将被告知,并将其物质作为已合格的物质发布在其协会的刊物中。

  Once the final rule is published, CVM will accept GRAS notifications. It is anticipated that GRAS notifications submitted for use of substances in animal feed will be posted on the CVM Home Page. When a GRAS notification raises no issue of concern to CVM, the AAFCO Feed Ingredient Chair will be notified so that the substance and its use can be listed in the AAFCO publication.

食品强化剂及健康教育法案  The Dietary Supplement and Health Education Act 

  当国会在1994年10月25日颁布《食品强化剂及健康教育法案》时,创造了一个新的物质分类法以及一套新的监督管理方案。其法案中修订了食品强化剂在食品生产中作为增强,补充某种食品所用时,至少含有一种或多种以下材质:一种维他命;一种矿物质;一种草药或植物性食材;一种氨基酸;一种旨在增加食品摄入量而添加的物质;或者一种浓缩的,代谢的,提炼的,萃取的,也或者由上述方法组合制成的物质(详见法案201(ff) 部分)。健康教育法案(DSHEA)主要作用是在某种食材的售前批准程序中,撤销某种作为食品添加剂的材质。在1996年4月22日,兽医中心曾公布过联邦公报揭示为什么我局(FDA)不将健康教育法案(DSHEA)应用到动物食品中去,且此公报至少在一次法庭讼案中被支持。因此,当申请某种物质作为动物食品中的食品强化剂时仍须归入人类食品的售前健康教育管辖,即其物质会被被作为一种食品,一种添加剂或者一种新型动物药物,又或者是一种一般认为安全的物质(GRAS)取决于其预期作用。目前大多数在市流通的此类产品按其预期作用来看,多被视为未被批准的以及不安全的食品添加剂或者一种新型动物药品。

  When Congress enacted the Dietary Supplement and Health Education Act (DSHEA) on October 25, 1994, it created a new category of substances and new regulatory scheme. The Act was amended to define a dietary supplement as a product intended to supplement the diet and that contains at least one or more of the following ingredients: a vitamin; a mineral; a herb or other botanical; an amino acid; a dietary substance for use to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract or combination of any of the previously mentioned ingredients (Sec. 201 (ff) of the Act). The main effect of DSHEA was to remove certain dietary ingredients from regulation as food additives, which requires pre-market approval. On April 22, 1996, CVM published a notice in theFederal Register outlining the reasons why FDA believes that Congress did not intend DSHEA to apply to substances for use in animals. This has been upheld in at least one court case. Thus, substances marketed as dietary supplements for humans still fall under the pre-DSHEA regulatory scheme when marketed for animals; that is, they are considered food, food additives, new animal drugs, or GRAS depending on the intended use. Most of these types of products on the market would be considered unapproved and unsafe food additives or new animal drugs based on current intended uses.

食品标签的健康声明  Health Claims 

  国会在1990年也修订过法案,当营养标识和健康教育法颁布时,此法案要求我局(FDA)编撰关于批准在人用食品上标注食品健康声明的法规。有相当数量的食品已经被批准,具体名单可从营养中心(CFSAN)主页上找到。

  Congress also amended the Act when it enacted the Nutrition Labeling and Education Act in 1990. This law required FDA to write regulations to permit health claims on human food. A number of these claims have been approved for various foods. These can be found on the CFSAN web page.

  兽医中心已经综合了营养标识和健康教育法案(NLEA)中的理念旨在宠物食品应用中批准有意义的健康方面信息,比如:在猫粮中注明食品对猫科动物泌尿系统健康的声明,以及美国饲料管制协会(AAFCO)中要求明确,精细,少添加或者减少卡路里,或者明确,精细,少添加或者减少脂肪含量。最近,兽医中心已经被要求完善其对控制猫类食品中对毛球病影响的因素。我们可能不会对那些已通过批准的且已达到要求功效的用以猫类食品的原料进行监管活动,比如:纤维来源。在这种情况下,我们要求申报公司提交已经从一定数量的食品,配制剂,营养成分分析以及标识中得出的信息,并给予以上信息审议后做出健康声明。也就是说,基于某种材质的生物学目的的科学研究常识。如果该物质已证明可达到某种功效,则我局会认为该申报物质已证明安全并应当具备市场准入条件。

  CVM has incorporated the philosophy of NLEA in its policies in order to permit meaningful health information on pet foods. Examples are the use of urinary tract health claim on cat food diets, and development of AAFCO regulations for light, lean, less or reduced calories, lean, and less or reduced fat. Recently, CVM has been asked about complete cat foods for the control of hairballs. We would likely not take regulatory action provided the effect is achieved by ingredients already permitted for use in cat food, such as fiber sources. In this case, we ask that the firm submit information for review on the quantitative diet formulation, nutrient analysis, and labeling, and discussion on the basis for the claim, i.e., scientific studies or common knowledge of ingredients biological properties. If novel ingredients are used to achieve the effect, then we believe data demonstrating ingredient safety should be obtained prior to marketing.

  重点指出的是在健康教育法案中(DSHEA)定义术语“食品强化剂”时排除了预期目的作为传统食品的物质。比如:圣约翰麦芽汁在添加到汤里时,不被视为一种食品强化剂。汤是一种传统食品,而任何被添加进传统食品的物质必须符合食品添加剂法规或者必须是一种一般认为安全的物质(GRAS)。

  It is important to note that DSHEA defines the term "dietary supplement" to exclude products intended for use as conventional foods. For example, St. John's Wort would not be considered a dietary supplement if it were added to soup. Soup is a conventional food and any ingredient added to conventional foods must be used in accordance with the food additive regulation or be GRAS.Congress also amended the Act when it enacted the Nutrition Labeling and Education Act in 1990. This law required FDA to write regulations to permit health claims on human food. A number of these claims have been approved for various foods. These can be found on the CFSAN web page.

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