监管逐渐完善 质检仍存盲区

  国家市场监督管理总局特殊食品监管司司长周石平表示,党的十八大以来,在各级监管部门和食品生产企业的共同努力下,食品安全形势总体稳定向好,食品安全保障水平正处于历史最好时期。尤其在特殊食品的安全保障方面,监管部门采取了一系列前所未有的重大举措,严字当头,“放管服”结合,以监管制度的创新引领特殊食品产业转型升级、提质增效、供给侧结构性改革。近两年先后出台了20多项特殊食品方面的监管制度和法律法规,包括《特殊医学用途配方食品注册管理办法》《保健食品注册与备案管理办法》《婴幼儿配方乳粉产品配方注册管理办法》和与之配套的实施细则、规范性文件;同时结合特殊食品的特点,在食品生产经营许可、日常监督检查管理等方面明确了区别于普通食品的监管要求和政策措施,努力在监管中强化服务,在服务中加强监管。与此同时,国家市场监管总局努力改革审评审批制度,为特殊食品生产监管提供更大的“放”,更好的“管”,更优的“服”。
  对于特殊食品的质量检测仍然存在盲区的现象,北京市食品安全监控和风险评估中心(国家食品质量安全监督检验中心)总工程师曹红分析说,以婴幼儿配方奶粉为例,婴幼儿配方奶粉中添加的酪蛋白磷酸肽(CPP)、乳铁蛋白、低聚半乳糖、1,3-二油酸-2-棕榈酸甘油三酯(OPO)等新型可选择营养成分,目前仍暂无国标检测方法;目前有国标方法但检测中仍存在问题的脂肪酸、肌醇、核苷酸、牛磺酸、β-胡萝卜素、碘和氯等物质,虽然国标中有规定的检测方法,但实际操作中还存有争议。这些成分因不同企业的不同原料来源、生产环境、生产方法以及生产含量的不同,甚至存在同一企业不同批次的产品含量存在较大差异;或者因配方中不同成分的比例高而使检测结果存在较大误差,质量检测存在一定的局限性。据了解,北京市食品安全监控和风险评估中心已接受原国家食药监总局委托开展方法研究和调研工作,以集中优势力量开展相关项目的科研攻关,进一步推动和完善我国婴幼儿配方乳粉标准体系建设,提升我国婴幼儿配方乳粉产品国际竞争力。
  河北省市场监督管理局党组书记丁锦霞表示,我国新修订的食品安全法明确了特殊食品的法律地位,为特殊食品产业更好、更快发展奠定了法律基础,也体现出党和政府加强特殊食品安全监管、促进特殊食品产业发展的决心。对于企业来说,在配合有关部门监管的同时,也要严格自查。
  河北三元食品有限公司技术中心主任、北京三元食品股份有限公司技术中心副主任李朝旭表示,特殊食品的监管会越来越严格,消费者特定的需求越来越明显,产品越来越复杂,投入大且市场取得回报时间长,可以说对特殊食品的研究开发一定程度上难度要大于药品。而且注册门槛很高,产品市场主要被几家国际巨头垄断,我国尚处于起始阶段,特殊食品产品的研究开发是一个巨大的挑战。河北省食品检验研究院审查技术部部长吴磊提醒企业,特殊医学用途配方食品的生产必须与产品注册相互认可,监管部门会按照注册时申请的原料、配方、生产工艺条件进行检查,不能擅自改变。“以前,监管部门对硬件设施进行大力度检查,如今我国许多企业的硬件设施达到世界第一水平,反而是生产规范达不到要求。”吴磊表示,严格生产管理制度,对关键环节的控制、原料的管理、高标准检验管理等都是目前企业需要尽快提升的部分。
  中国工程院院士丛斌对我国特殊食品产业发展提出了几点建议。他表示,首先要充分认识特殊食品产业发展和质量安全工作的重要性,充分发挥专家委员会专家特长,为科学监管提供技术咨询和技术支撑;同时,专委会要积极开展国内外学术交流与合作,为行业健康发展提供信息共享平台。“特殊食品和普通食品不一样,一定程度上承担着临床、辅助治疗的作用。这就要求有较高的技术含量,严格的技术标准,高质量的生产原料。而且,中医药是我国特有资源,应将药食同源的中药纳入特殊食品配方中。”
市场潜力巨大 发展尚多困扰
  近年来,随着我国居民生活水平和健康意识的不断提高,人们的生活方式和观念也在不断改变,从满足基本生理需要向均衡营养摄入、利于身体健康转变;从有病治病,向无病预防、提高健康质量转变。特殊医学用途配方食品正是随着时代的进步、医学的发展、社会的需求而逐步发展起来的,为疾病患者等某些特殊人群提供特殊营养支持,其在有效减少并发症、降低死亡率、增强治疗效果、降低治疗成本、改善患者生活质量、延长晚期肿瘤患者生存期等方面具有重大的社会价值。
  特殊食品抽检监测专家委员会副主任委员王丽霞表示,由于我国特医食品行业起步较晚,市场体系还不够成熟,人口基数庞大、老龄化程度持续加深、慢性病患者快速增长、全面放开二孩政策等现状和客观因素,特殊人群的数量不断增加,其营养健康需求日益攀升。因此,我国特医食品市场潜力巨大,而且正迎来前所未有的发展机遇和重大挑战。
  特殊医学用途配方食品是指为满足进食受限、消化吸收障碍、代谢紊乱或者特定疾病状态人群对营养素或者膳食的特殊需要,专门加工配制而成的配方食品,特殊医学用途配方食品属于特殊膳食食品。在全球特医、特膳食品消费高速增长的背景下,我国特殊食品产业仍处在初级发展阶段,但我国市场前景广阔,特殊食品将成为未来健康产业大蓝海。
  从全球来看,特医食品产业呈现蓬勃发展之势。据统计,全球每年消费特医食品约560亿—640亿元人民币,市场每年以6%的速度递增。欧美年消费量占据全球较大比重,约为400亿—500亿元人民币,增速为4.5%;日本和韩国的市场规模为150亿—220亿元人民币,增速为4.8%。在我国,特医食品的应用起步较晚,但随着新修订的食品安全法明确了特医食品的“食品”身份以及2016年注册管理办法、临床试验质量管理规范等配套政策法规的出台,特医食品产业开始快速发展,2017年国内总产值达33.7亿元,较2016年增长30.12%;2017年国内产量达2.47万吨,同比增长37%;2017年行业需求量为3.66万吨,同比增长27.53%。但从规模来看,我国占全球市场不到3%,与发达国家存在较大差距。鉴于我国拥有全球最大的特医食品消费市场,健康需求迫切且多样,业内人士预测,到2020年,国内特医食品销售额将超过200亿元,2025年将突破1000亿元。
  面对如此巨大的蓝海,特医食品产业发展仍面临种种困境。从实施的特医食品注册许可来看,国家设定了高门槛,对生产企业的研发能力、生产能力、检验能力以及申请人资质条件、审评审批程序、标签标志、临床试验、监督检查和法律责任等提出了具体而严格的要求。特医食品作为新兴产业,患者、医院、企业认知度不够,市场培育需要一定的时间和过程。除此之外,外资企业主导市场,国内自主研发生产的产品却难觅踪影;新政策下,对特医食品的监管会越来越严格,非常明确的营养素要求会导致严重的产品同质化现象,市场竞争将异常激烈。因此,如何加强产品的研发、生产和管理,尽早突破准入门槛,有效利用新政策的规范和保护,打破国外垄断,并在众多同质产品中脱颖而出,是国内特医食品企业和想要进入该行业的企业都必须认真思考和研究解决的问题。
  除了企业研发、推广难,医院作为特医食品临床应用的主要场所也存在许多问题。据统计,我国每年近亿人次的住院病人中,营养诊断率不足万分之一,我国住院和门诊病人的营养诊断和营养治疗率低是我国医疗服务中的一种普遍现象。北京清华长庚医院临床营养科主治医师林兵提出,当前我国特医食品在管理上问题凸显,缺乏与临床医生在肠内营养工作上的诊疗协作,特医食品收费路径不通畅,缺乏特医食品规范化的流程管理理念,虽然目前已经有特殊医学用途配方食品临床应用规范(征求意见稿),但因各地区医院在应用规范上差别较大,且需考虑成本,因此规范化的推进仍受重重阻碍。鉴于特医食品在治疗过程中的重要辅助作用及其市场需求和发展前景,各医疗机构应更加重视特医食品的规范化应用。基于“营养风险筛查—营养评估—营养治疗”的临床思路,强调适应症和禁忌症,以满足患者的营养治疗需求,包括住院、出院和门诊患者,临床路径应实现规范化和信息化管理。

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