十天EC1935_2004食品接触类原料和制品(欧盟)1935_2004指令_中英文整理版

2021年1月22日发(作者：匹克英文)
REGULATION (EC) No 1935/2004 OF THE
EUROPEAN PARLIAMENT AND OF THE
COUNCIL
of 27 October 2004
on materials and articles intended to come into
contact with food and repealing Directives
80/590/EECand 89/109/EEC
2004
年
10
月
27
日发布关于 食品接触类原料和物料的欧
盟
1935/2004
指令，同时撤销原欧洲共同体
80/590
和
89/109
指令

THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN
UNION,
欧洲议会与理事会

Having regard to the Treaty establishing the European
Community,
and in particular Article 95 thereof,
注意到建立欧洲共同体的《条约》，特别是第
95
条

Having regard to the proposal from the Commission,
注意到委员会的提案

Having regard to the opinion of the European Economic
and
Social Committee (1),
注意到欧洲经济和社会委员会的意见（
1
）

Acting in accordance with the procedure laid down in
Article 251
of the Treaty (2),
按照《条约》第
251
条规定的程序（
2
）

Whereas:
鉴于

(1) Council Directive 89/109/EEC of 21 December 1988
on the approximation of the laws of the Member States
relating to materials and articles intended to come into
contact with foodstuffs (3) established general principles
for eliminating the differences between the
laws of the
Member States as regards those materials and articles and
provided for the adoption of implementing directives
concerning specific groups of materials and articles
(specific directives). This approach was successful and
should be continued.
理事会
1988
年
1 2
月
21
日的指令
89 /109 /EEC
关于
统一各成 员国材料和制品用于接触食品的法律，为消
除各成员国关于这些原料和物料制定的差异，以及为
特定材料和物品（具体指令）提供通过执行的指令而
建立的一般原则。这种做法是成功的并会延续下去。


(2) The specific directives adopted under Directive
89/109/EEC in general contain provisions which leave
little room for the exercise of discretion by the Member
States in their transposition besides being subject to
frequent amendments required to adapt them rapidly to
technological progress. It should therefore be possible for
such measures to take the form of regulations or decisions.
At the same time it is appropriate to include a number of
additional subjects. Directive 89/109/EEC should
therefore be replaced.
具体通过
89 /109 /EEC
的指令一般来说囊括的规定都
没有空间让 成员国在法律移植上斟酌运用，除了遇到
要求快速适应技术上进步的常见修正。因此，这应当
可 以采用相关方法决定规章或决议的形式。同时，添
加额外的项目是可取的。
89/109/EE C
指令因此被取代。

(3) The principle underlying this Regulation is that any
material or article intended to come into contact directly
or indirectly with food must be sufficiently inert to
preclude substances from being transferred to food in
quantities large enough to endanger human health or to
bring about an unacceptable change in the composition of
the food or a deterioration in its organoleptic properties.
此规章的基本原则是任何用于直接或间接接触食物原
料或物件对于在 传输一定数量食物过程中危害人类健
康或者给食物结构带来不可接受的改变或者恶化其感
官作用 的物质呈现充分的惰性反应。

(4) New types of materials and articles designed to
actively maintain or improve the condition of the food
(active food contact materials and articles) are not inert
by their design, unlike traditional materials and articles
intended to come into contact with food. Other types of
new materials and articles are designed to monitor the
condition of the food (intelligent food contact materials
and articles). Both these types of materials and articles
may be brought into contact with food. It is therefore
necessary, for reasons of clarity and legal certainty, for
active and intelligent food contact materials and articles
to be included in the scope of this Regulation and the
main requirements for their use to be established. Further
requirements should be stated in specific measures, to
include positive lists of authorized substances and/or
materials and articles, which should be adopted as soon as
possible.
所有旨在积极保持或提高食品 （活性食品接触的原料
或物件）状况的新款式的原料或物件在设计过程中必
须呈现惰性，
不同于以往新原料或物件会接触到食物。
其他新原料或物件需用于监测食品（智能型食品接触
的原料或物件）状况。这两种原料或物件可能会接触
到食物。所以，出于明确原因和合法性，对于活性食
品和智能型食品的接触原料或物件都在此规章范围
内，以及它们使用的主要要求也有明确规定。 那些尽
快被采用的进一步要求包括授权物质和原料或物件的
准许进口货单将规定在具体措施中。

1
(5) Active food contact materials and articles are
designed to
deliberately incorporate ‘active’ components
intended to be released into the food or to absorb
substances from the food. They should be distinguished
from materials and articles which are traditionally used to
release their natural ingredients into specific types of food
during the process of their manufacture, such as wooden
barrels.
活性食品接触的原料或物件旨在有意的吸收释放到食
物中的“活性 ”成分或者从食物中吸收物质。它们在
生产过程中，如木桶的生产，必须区分那些传统用于
释放 天然配料到具体食物中的原料与物件。

(6) Active food contact materials and articles may change
the composition or the organoleptic properties of the food
only if the changes comply with the Community
provisions applicable to food, such as the provisions of
Directive 89/107/EEC (4) on food additives. In particular,
substances such as food additives deliberately
incorporated into certain active food contact materials and
articles for release into packaged foods or the
environment surrounding such foods, should be
authorised under the relevant Community provisions
applicable to food and also be subject to other rules which
will be established in a specific measure.
活性食品接触的原料或物件当且只有符合食品的社区
规定，如
89/107/EEC (4)
指令中的食品规定，才可以改
变其成分或感官特性。特别是某些特定的活性食品的
食品添加剂所接触的原料和物件释放到包装上或周围
的环境等，应当授权于相应的食品社区规定同时要 遵
循即将成立的具体措施规定。

(1) OJ C 117, 30.4.2004, p. 1.
(2) Opinion of the European Parliament of 31 March
2004 (not yet published in the Official Journal) and
Council Decision of 14 October 2004.
2004
年
3
月
31< br>日的欧盟议会意见（还没在官方期刊出
版）和
2004
年
10
月
14
日理事会决议

(3) OJ L 40, 11.2.1989, p. 38. Directive as amended by
Regulation (EC) No 1882/2003 of the European
Parliament and of the Council(OJ L 284, 31.10.2003, p.
1)
指令由欧盟议会和理事会的
1882/2003
规章修改

.(4) Council Directive 89/107/EEC of 21 December 1988
on the approximation of the laws of the Member States
concerning food additives authorised for use in foodstuffs
intended for human consumption(OJ L 40, 11.2.1989, p.
27). Directive as last amended by Regulation (EC) No
1882/2003.L 338/4 EN Official Journal of the European
Union 13.11.2004
理事会
1988
年
12
月
21
日的指令
89 /109 /EEC
关于
统一各成员国授权使用添加剂的法律
(OJ L 40,

11.2.1989, p. 27)
。指令最后由
13.11.2004
官方期刊的
No 1882/2003.L 338/4
规章修正

In addition, adequate labelling or information should
support users in the safe and correct use of active
materials and articles in compliance with the food
legislation, including the provisions on food labelling.
除此以外，提供充足的满足食品法规 的标签或者信息
支持用户处于安全和活性原料和物件的正确使用

(7) Active and intelligent food contact materials and
articles should not change the composition or the
organoleptic properties of food or give information about
the condition of the food that could mislead consumers.
For example,active food contact materials and articles
should not release or absorb substances such as aldehydes
or amines in order to mask an incipient spoilage of the
food. Such changes which could manipulate signs of
spoilage could mislead the consumer and they should
therefore not be allowed.
活跃性和智能型的食品触点原料和物件不应该改变其
组成或 者食品的感官特性或者给关于能误导消费者食
品状态的信息。例如，活跃性食品触点原料和物件不
应该释放或者吸收像乙醛或者胺那样的物质从而为了
掩饰食品的开始变化。这样能操纵变质迹象的变化 能
误导消费者，因此不被允许。

Similarly, active food contact materials and articles which
produce colour changes to the food that give the wrong
information concerning the condition of the food could
mislead the consumer and therefore should not be
allowed either.
与此类似，活性食品触点原 料和物件换乘错了信息关
于食品的状态可能误导消费者的给的食品，

因此也不
被允许。


(8) Any material or article intended to come into contact
with food which is placed on the market should comply
with the requirements of this Regulation. Nevertheless,
materials and articles supplied as antiques should be
excluded as they are available in restricted quantities and
their contact with food is therefore limited.
所有要接触食品的原料或物件在投入市场前需要符合
这条规章的要求。


虽然如此，

视为古董的原料或物
件排除在一定限制数量内是被允许的情况， 因此接触
食品也是被限制的。

(9) Covering or coating materials forming part of the food
and possibly being consumed with it should not fall
within the scope of this Regulation. On the other hand,
this Regulation should apply to covering or coating
materials which cover cheese rinds, prepared meat
products or fruit but which do not form part of food and
are not intended to be consumed together with such food.
可能和食物一起使用的组成部分覆盖原料或涂料表层
2
不适合这条规章的范围。另一 方面，这条规章应该适
用于那些非组成部分的且不一起消费使用的涂层原料
如盖住乳酪皮、预加 工肉产品或者水果的涂料表层。

(10) It is necessary to lay down various types of
restrictions and conditions for the use of the materials and
articles covered by this Regulation and the substances
used in their manufacture. It is appropriate to establish
those restrictions and conditions in specific measures
having regard to the technological characteristics specific
to each group of materials and articles.
对此规章覆盖的原料和物件的使用情况和其生产过程
中使用的材料，制定 不同类型限制和制约是非常必要
的。对各组原料和物件的具体关于技术性质细节的措
施建立限制 条件是合适的。

(11) Pursuant to Regulation (EC) No 178/2002 of the
European Parliament and of the Council of 28 January
2002 laying down the general principles and requirements
of food law, establishing the European Food Safety
Authority and laying down procedures in matters of food
safety (1), the European Food Safety Authority (the
Authority) should be consulted before provisions liable to
affect public health are adopted under specific measures.
(11)
按照欧盟议会的
(EC) No.178/2002
规章和
2002
年
1
月
28
日委员会拟定总则和食品法律的要求，建立欧 洲
食品安全局并且对有关食品安全拟定程序

( 1 ) ,
在具
体 措施下影响公众健康的规定采用前，需要咨询欧洲
食品安全局的意见。

(12) When specific measures include a list of substances
authorized within the Community for use in the
manufacture of materials and articles intended to come
into contact with food, those substances should undergo a
safety assessment prior to their authorisation. The safety
assessment and authorisation of those substances should
be without prejudice to the relevant requirements of the
Community legislation concerning the registration,
evaluation, authorization and restriction of chemicals.
当具体措施包括用于生产接触食品类的原料和物件的
一系列社区授权物 质，这些物质必须经过安全评估阶
段才能获得授权。这些物质的安全评估和授权必须不
影响共同 体就注册、评估、授权和化学限制的相关立
法要求。

(13) Differences between national laws, regulations and
administrative provisions concerning the safety
assessment and authorisation of substances used in the
manufacture of materials and articles intended to come
into contact with food may hinder the free movement of
those materials and articles, creating conditions of
unequal and unfair competition. An authorisation
procedure should therefore be established at Community
level. In order to ensure harmonized safety assessment of
those substances, the Authority should carry out such
assessments.

国家法律、规章和管理条例对在接触食品的原料和物< br>质生产过程中所用的物质的安全评估和授权的规定差
别，会阻碍这些原料和物件的自由活动，产生 不平等
和不公平的竞争。
因此审定程序须在社区水平上建立。
为了保证这些物质安全评 估协调，食品安全局须执行
这样的评估。

(14) The safety assessment of substances should be
followed by a risk management decision as to whether
those substances should be entered on a Community list
of authorized substances.
物质的安全评估必须遵循风险管理决定，不管这些物
质是否列入社区授权目录

(15) It is appropriate to provide for the possibility of an
administrative review of specific acts or omissions on the
part of the Authority under this Regulation. This review
should be without prejudice to the role of the Authority as
an independent scientific point of reference in risk
assessment.
就此规章下的安全局 而言，为具体作为或不作为的，
提供可能性管理检阅是合适的。这种检阅在风险评估
中作为独立 的科学参考点，对于安全局的角色不能有
任何偏倚。

(16) Labelling supports users in the correct use of the
materials and articles. Methods used for such labelling
may vary according to the user.
标签支持用户正确使用原料和物件。标签的使用方法
可以根据用户做相应的改变。

(17) Commission Directive 80/590/EEC (2) introduced a
symbol that may accompany materials and articles
intended to come into contact with foodstuffs. This
symbol should, for reasons of simplicity, be incorporated
in this Regulation.
委托指令的
80/590 /EEC( 2 )

采用一种符号可以伴随
接触食品的原料和物件。这各符号出于简化的原因，
应该被并入这条规章里。

(18) The traceability of materials and articles intended to
come into contact with food should be ensured at all
stages in order to facilitate control, the recall of defective
products, consumer information and the attribution of
responsibility. Business operators should at least be able
to identify the businesses from which, and to which, the
materials and articles are supplied.
(1) OJ L 31, 1.2.2002, p. 1. Regulation as amended by
Regulation (EC) No
1642/2003 (OJ L 245, 29.9.2003, p. 4).
(2) Commission Directive 80/590/EEC of 9 June 1980
determining the symbol that may accompany materials
and articles intended to come into contact with foodstuffs
(OJ L 151, 19.6.1980, p. 21). Directive as last amended
by the 2003 Act of Accession
3
13.11.2004 EN Official Journal of the European Union L
338/5
接触食品 类的原料和物件保证在任何阶段都可以追
溯，为了便于控制，瑕疵品的回收，客户信息和责任
归 因。交易运营商最低限度必须做到识别出原料和物
件是从哪里来，运到哪里去。

(1)
根据规章
(EC)NO.1642/2003(OJ L 245
，
29.9.2003
，

页


4).
修改的规章
OJ L 31
，
1.2.2002
，

页


1.
(2)
欧盟委员会
1980
年
6
月
9
日关 于确定接触食品类原料
和物件的
80/590/EEC
指令。此法规以
200 3
指令添加到
2004
年
11
月
13
日的欧盟L L 338/5
联合公报为最后修
正。

(19) In the control of the compliance of the materials and
articles with this Regulation, it is appropriate to take into
account the special needs of developing countries, and in
particular of the least developed countries. The
Commission has been committed by Regulation (EC) No
882/2004 of the European Parliament and of the Council
of 29 April 2004 on official controls performed to ensure
the verification of compliance with feed and food law,
animal health and animal welfare rules (1) to support
developing countries with regard to food safety, including
the safety of the materials and articles in contact with
food. Special provisions have therefore been established
in that Regulation which should be applicable also to the
food contact materials and articles.
(19)
对受控于此规则的原料和物件，
应该考虑发展中国家，特别是不发达国家的特殊需求。委员会遵循欧盟
议会
No 882/2004
和
2004
年
4
月
29
号的理事会，
关于
执行确定饲料和食品法、
动物的健康和动物福利法规（
1
）受
控事实
的官方管理手段，以确保发展中国家的食品，包
括接触食品原料和物件的安全。具体条例因此成立，同时适用于接触食品的原料和物件。


(20) It is necessary to establish procedures for the
adoption of safeguard measures in situations where a
material or article is likely to constitute a serious risk to
human health.
(20)
当原料或物件对人类有一系列持续的危害，
需要建
立保卫措施的程序


(21) Regulation (EC) No 1049/2001 of the European
Parliament and of the Council of 30 May 2001 regarding
public access to European Parliament, Council and
Commission documents (2) applies to documents held by
the Authority.
2001
年
3
月
30
日欧盟议会和 理事会关于公众参与欧盟
议会、
理事会和共同体文献的
(EC) No 1049/2001
规章，
适用于安全局执行文献。

(22) It is appropriate to protect the investment made by
innovators in gathering the information and data
supporting an application made under this Regulation. In
order to avoid unnecessary repetition of studies and in

particular animal testing, however, sharing of data should
be permitted provided there is agreement between the
interested parties.
保护搜集支持此规章下 实际应用的信息和数据的改革
人的投资是合理的。为了避免不必要的重复实验，特
别是动物测试 ，然而，在利益关系的双方同意下，分
享数据时允许的。

(23) Community and national reference laboratories
should be designated to contribute to a high quality and
uniformity of analytical results. This objective will be
achieved within the framework of Regulation (EC) No
882/2004.
(23)
欧共体和国家参数实验室必须致力于高品质和一
致性的分析结果。
这个目标将在在
(EC) No 882/2004
规
章框架下得到实现。

(24) The use of recycled materials and articles should be
favoured in the Community for environmental reasons,
provided that strict requirements are established to ensure
food safety and consumer protection. Such requirements
should be established taking also into account the
technological characteristics of the different groups of
materials and articles mentioned in Annex I. Priority
should be given to the harmonisation of rules on recycled
plastic material and articles as their use is increasing and
national laws and provisions are lacking or are divergent.
Therefore, a draft of a specific measure on recycled
plastic materials and articles should be made available to
the public as soon as possible in order to clarify the legal
situation in the Community.
对于回收原料和物件的使用需符合共同体出于环境因
素为了保证食品安 全和消费者的保护而制定严格要
求。这些要求也要考虑附件一提及的各类原料和物件
的技术特征 。再循环的塑料原料和物件使用量增加，
当国家法律和规章有分歧时，优先考虑和谐持续的规
则 。因此，需要尽快起草有关回收利用的原料和物件
的具体措施，从而明确共同体的合法性。

(25) The measures necessary for the implementation of
this Regulation and amendments to Annexes I and II
hereto should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down the
procedures for the exercise of implementing powers
conferred on the Commission (3).
此规 则的必要执行措施和附件
1,2
的修正必须与理事会
1999
年
6< br>月
28
日的
{1999/468/EC
决定
}
规定的 执行权力
程序相符。

(26) Member States should lay down rules on sanctions
applicable to infringements of the provisions of this
Regulation and ensure that they are implemented. Such
sanctions must be effective, proportionate and dissuasive.
会员国应该制定评定违反这条规章条 款的制裁并保证
其有效性。这些制裁必须是有效的，均衡的和有劝诫
4
作用。

(27) It is necessary for business operators to have
sufficient time to adapt to some of the requirements
established by this Regulation.
应该给运营商足够的时间适应此规章的要求。

(28) Since the objectives of this Regulation cannot be
sufficiently achieved by the Member States because of
the differences between the national laws and provisions
and can therefore be better achieved at Community level,
the Community may adopt measures, in accordance with
the principle of subsidiarity as set out in Article 5 of the
Treaty. In accordance with the principle of
proportionality, as set out in that Article, this Regulation
does not go beyond what is necessary in order to achieve
those objectives.
基于国家间的法律和条约有差异，各国不能保证达到< br>此规章的目标，因此，在共同体的基础上会达到更好
的效果，共同体也许会根据条约第五章辅助原 则采用
一系列措施。依照条款的均衡性原则，为了达到这些
目标，此规章超出其范围。

(29) Directives 80/590/EEC and 89/109/EEC should
therefore be repealed,
HAVE ADOPTED THIS REGULATION:
指令
80/590 /EEC
和
89/109 /EEC
因此应该被废止，

已经采用这条规章：


第
1
条


Article 1
Purpose and subject matter
1. The purpose of this Regulation is to ensure the
effective functioning of the internal market in relation to
the placing on the market in the Community of materials
and articles intended to come into contact directly or
indirectly with food, whilst providing the basis for
securing a high level of protection of human health and
the interests of consumers.
(1) OJ L 165, 30.4.2004, p. 1. Regulation as corrected in
OJ L 191,
28.5.2004, p. 1.
(2) OJ L 145, 31.5.2001, p. 43.

(3) OJ L 184, 17.7.1999, p. 23
L 338/6 EN Official Journal of the European Union
13.11.2004
目的和主要内容


1. < br>这条规章的目的是为了保证直接或间接接触食品类
的原料和物件国际市场的高效运作，时时为人类 健康

和客户利益提供固定的高水准保护

(1) OJ L 165
，
30.4.2004
，
页
1.
作为

OJ L 191 28.5.2004 ,
页
1.
修正版


(2) OJ L 145
，
31.5.2001
，页
43.
(3) OJ L 184
，
17.7.1999
，页
23
，
13.11.2004
的政府公
关

L 338/6

2. This Regulation shall apply to materials and articles,
including active and intelligent food contact materials and
articles, (hereinafter referred to as materials and articles)
which in their finished state:
(a) are intended to be brought into contact with food;or
(b) are already in contact with food and were intended for
that purpose;or
(c) can reasonably be expected to be brought into contact
with food or to transfer their constituents to food under
normal or foreseeable conditions of use.
2.
这条规章将适用于接触活性食品和智能型食品的原
料和物件，
(
在下文称为的原料和物件
)


(a)
计划与食品接触；或者


(b)
已经与食品接触，并且已打算倾向于那目的；

或
者


(c)
在平常或者可预见的情况下能购买到与食品接触
或者转移成分到食品的

3. This Regulation shall not apply to:
(a) materials and articles which are supplied as antiques;
(b) covering or coating materials, such as the materials
covering cheese rinds, prepared meat products or fruits,
which form part of the food and may be consumed
together with this food;
(c) fixed public or private water supply equipment.
3.
这规章将不适用于：


(a)
作为古董的原料和物件；


(b)
涂层材料，
例如包装乳酪皮，
预加工肉产品或者水
果，组成食品的部分和可能和食品一 起食用的；


(c)
修理公众或私人用水设备。


Article 2
Definitions
1. For the purposes of this Regulation, the relevant
definitions laid down in Regulation (EC) No 178/2002
shall apply, with the exception of the definitions of
‘traceability’ and ‘placing on the

market’, which shall
have the following meanings:
(a) ‘traceability’: the ability to trace and follow a material
5
or article through all stages of manufacture, processing
and distribution;
(b) ‘placing on the market’: the holding of materials and
articles for the purpose of sale, including offering for sale
or any other form of transfer, whether free of charge or
not, and the sale, distribution and other forms of transfer
themselves.
第
2
条


定
义


1.
为了这条规章的目的，
指令
(EC)No. 178/2002
制定的
相应定义，“可追溯的”和“在市场配售”的定义例
外，需要有以下的定义：

(a)
可追溯性：

在生产，整合和运输的所有阶段都能
追溯和跟踪原料或物件

(b)
可在市场配售
'
：

为了销售而持有的那些原料和物
件，包 括供应商或其他形式的经销商，是否免费，以
及销售，分配和其他形式经销。

2. The following definitions shall also apply:
(a) ‘active food contact materials and articles’ (hereinafter

referred to as active materials and articles) means
materials and articles that are intended to extend the
shelf-life or to maintain or improve the condition of
packaged food. They are designed to deliberately
incorporate components that would release or absorb
substances into or from the packaged food or the
environment surrounding the food;
2.
下列定义也将适用：


(a)
接触活性食品的原料和物件
(
在下文称为的活性原
料和物件
)
意思是为了延长保质期或保持或提高包装
食品的状态。它们含有那些可以 从包装食品或食品周
边环境释放或吸收物质。

(b) ‘intelligent food contact materials and articles’
(hereinafter referred to as intelligent materials and articles)
means materials and articles which monitor the condition
of packaged food or the environment surrounding the
food;
(b)
接触智能型食品的原料和物件
(
在下文称为智 能型
原料和物件
)
意思是能监察包装食品或食品周围环境
的情况。

(c) ‘business’ means any undertaking, whether for profit
or not and whether public or private, carrying out any of
the activities related to any stage of manufacture,
processing and distribution of materials and articles;
(c)
商业单位意思为那些从事这些原料和物件在生产，
加工 和分销的任何阶段的任何活动，无论是公众事业
还是私人事业。

(d) ‘business operator’ means the natural or legal persons
responsible for ensuring that the requirements of this

Regulation are met within the business under their
control.
(d)
“

商业运营商”
意为自然人或法人有责任在其控制
范围内保证达到此规章规定的要求。

Article 3
General requirements
1. Materials and articles, including active and intelligent
materials and articles, shall be manufactured in
compliance with good manufacturing practice so that,
under normal or foreseeable conditions of use, they do
not transfer their constituents to food in quantities which
could:
(a) endanger human health; or
(b) bring about an unacceptable change in the
composition of the food; or
(c) bring about a deterioration in the organoleptic
characteristics thereof.
第
3
条


一般
规
格


1.
原料和物件，包括活性的和智能型的，需保证良好
的生产惯例能保证在正常或可 预见的情况下的使用都
不会在数量上传递组成要素到食物上致：

(a)
危害人健康；

或者


(b)
给食品组成带来不利的改变；

或者


(c)
恶化感官的特性


2. The labelling, advertising and presentation of a
material or article shall not mislead the consumers.
2.
产品标签、广告及外观不能误导消费者

Article 4
Special requirements for active and intelligent
materials
and articles
1. In the application of Article 3(1)(b) and 3(1)(c), active
materials and articles may bring about changes in the
composition or organoleptic characteristics of food on
condition that the changes comply with the Community
provisions applicable to food, such as the provisions of
Directive 89/107/EEC on food additives and related
implementing measures, or, if no Community provisions
exist, with the national provisions applicable to food.
13.11.2004 EN Official Journal of the European Union L
338/7
第
4
条


活
性
和智能化
原料和物件
的特
别
的要求

6
1.
在第三条
(1)(b)
和
(1)(c)
所列，活性原料和物件也许
会给食品的组成或感官性质带来变化，这些变化必须
服从
89/107/EEC
关于食物的指令和相关执行措施，或
者，如果没有共同体的指令存在，则 参考
2004
年
11
月
13
日欧盟政府公告

2. Pending the adoption of additional rules in a specific
measure on active and intelligent materials and articles,
substances deliberately incorporated into active materials
and articles to be released into the food or the
environment surrounding the food shall be authorised and
used in accordance with the relevant Community
provisions applicable to food, and shall comply with the
provisions of this Regulation and its implementing
measures. These substances shall be considered as
ingredients within the meaning of Article 6(4)(a) of
Directive 2000/13/EC (1).
2. 在对于活性和智能型材料采用额外规则期间，活性
材料包含的会释放到食品或其环境的物质需符合共 同
体关于食品的相应条例，还有此规章的规定及其执行
措施。这些物质即为
2000/ 13/EC (1)
指令的第
6
条
(4)(a)
所定义的配料。

3. Active materials and articles shall not bring about
changes in the composition or organoleptic characteristics
of food, for instance by masking the spoilage of food,
which could mislead consumers.
3.
活性的原料和物件不能改变食品的组成或感官特
性，如掩饰食品腐化来误导消费者。

4. Intelligent materials and articles shall not give
information about the condition of the food which could
mislead consumers.
智能型的原料和物件不能提供误导消费者的产品信
息。

5. Active and intelligent materials and articles already
brought into contact with food shall be adequately
labelled to allow identification by the consumer of
non-edible parts.
活性和智能型接触食品的原料和物件必须提供可分辨
的标签，提醒消费者不可食用。

6. Active and intelligent materials and articles shall be
adequately labelled to indicate that the materials or
articles are active and/or intelligent.
活性和智能原料和物件必须标上活性和
/
或智能型

Article 5
Specific measures for groups of materials and articles
1. For the groups of materials and articles listed in Annex
I and, where appropriate, combinations of those materials
and articles or recycled materials and articles used in the
manufacture of those materials and articles, specific
measures may be adopted or amended in accordance with

the procedure referred to in Article 23(2). Those specific
measures may include:
第
5
条


归类原料和物件
具体的措施


1.
在附件
1
所列的原料物件的归类以及这些材料的组
合物或生产过程中的回收利用，将会在
23
条（
2
）提及
的程序里采 用或修正具体措施。这些具体措施包括：

(a) a list of substances authorised for use in the
manufacturing of materials and articles;
列出生产过程中所用的授权物质

(b) list(s) of authorised substances incorporated in active
or intelligent food contact materials and articles, or list(s)
of active or intelligent materials and articles and, when
necessary, special conditions of use for these substances
and/or the materials and articles in which they are
incorporated;
列出活性或智能型接触食品的原料和物件所 包含的授
权物质，或活性（智能型）材料，当有必要时，还要
提供这些包含物质的具体使用情况 。

(c) purity standards for substances referred to in (a);
(a)
提及的物质有纯度指标。

(d) special conditions of use for substances referred to in
(a) and/or the materials and articles in which they are
used;
(a)
提及物质的具体使用情况

(e) specific limits on the migration of certain constituents
or groups of constituents into or on to food, taking due
account of other possible sources of exposure to those
constituents;
关于某些要素的转移或 在食物里边或表面的要素群的
具体限制，对于这些要素暴露的其他资料都要有适当
的数据记录< br>
(f) an overall limit on the migration of constituents into or
on to food;
食品内或表明的转移要素的整体限制
。

(g) provisions aimed at protecting human health against
hazards arising from oral contact with materials and
articles;
保护人类健康免受口服接触材料产生危害的条例

(h) other rules to ensure compliance with Articles 3 and
4;
其他符合第三条和第四条的规则。

(i) basic rules for checking compliance with points (a) to
(h);
7
符合（
a
）到（
h
）要点的基本检测规则

(j) rules concerning the collection of samples and the
methods of analysis to check compliance with points (a)
to (h);
符合（
a
）到（
h
）要点检测样品和分析方法的规则

(k) specific provisions for ensuring the traceability of
materials and articles including provisions regarding the
duration for retention of records or provisions to allow, if
necessary, for derogations from the requirements of
Article 17;
确保材料的可追溯性的具体条例 ，如果有必要，根据
第
17
条的损毁要求保存记录的时间或许可的条例。


(l) additional provisions of labelling for active and
intelligent materials and articles;
活性和智能型材料要有额外的标签规则。

(m) provisions requiring the Commission to establish and
maintain a publicly available Community Register
(Register) of authorised substances, processes, or
materials or articles;
委员会需要建立和保持一个公开的关于授权物质、进
程或材料的注册簿

(1) Directive 2000/13/EC of the European Parliament and
of the Council of 20 March 2000 on the approximation of
the laws of the Member States relating to the labelling,
presentation and advertising of foodstuffs (OJ L 109,
6.5.2000, p. 29). Directive as last amended by Directive
2003/89/EC (OJ L 308, 25.11.2003, p. 15). L 338/8 EN
Official Journal of the European Union 13.11.2004
2000
年
3
月< br>20
日欧洲议会和委员会
2000/13/EC
指令综
合各成员国关于 食品标签、外观和广告的法律
(OJ L
109, 6.5.2000, p. 29)
。指令于欧洲政府公告
2003/89/EC
(OJ L 308, 25.11.2003,
页
. 15). L 338/8
最后修订。

(n) specific procedural rules adapting, as necessary, the
procedure referred to in Articles 8 to 12, or making it
appropriate for the authorisation of certain types of
materials and articles and/or processes used in their
manufacture, including, where necessary, a procedure for
an individual authorization of a substance, process, or
material or article through a decision addressed to an
applicant.
具体程序上的规则根据需要适应第
8
到
12
条涉及的内
容，或者使其适用于某些类型的材料或其在生产 过程
包括个人授权的物质、制作法或者送样材料。

2. Existing specific directives on materials and articles
shall be amended in accordance with the procedure laid
down in Article 23(2).
2.
现存关于原料和物件的具体指令需根据第
23
条

( 2 )
作修正。



Article 6
National specific measures
In the absence of specific measures referred to in Article
5, this Regulation shall not prevent Member States from
maintaining or adopting national provisions provided they
comply with the rules of the Treaty.
第
6
条


国家具体的措施


在缺乏第
5
条提及的具体措施时，此规章不得阻止会员
国主张或采用条约规定的国际规则

Article 7
Role of the European Food Safety Authority
Provisions liable to affect public health shall be adopted
after consulting the European Food Safety Authority,
hereinafter referred
to as ‘the Authority’.

第
7
条


欧洲
食品
安全
局
的角色


可能影响公众健康安全的规则需在咨询欧盟食品安全
局后方可采用，以下简称安全局。

Article 8
General requirements for the authorisation of
substances
1. When a list of substances as referred to in points (a)
and (b) of the second subparagraph of Article 5(1) is
adopted, anyone seeking an authorisation for a substance
not yet included in that list shall submit an application in
accordance with Article 9(1).
第
8
条


物
质
的
审
定的一般
规
格

当需采用第
5
条（
1
）的第二段中
a
点和
b< br>点提及的一栏
物质，所有人对没有包含在内的物质需按照第
9
条（
1< br>）
提交申请书以获得授权书。

2. No substance shall be authorised unless it has been
adequately and sufficiently demonstrated that, when used
under the conditions to be set in the specific measures, the
final material or article satisfies the requirements of
Article 3 and, where they apply, Article 4.
当在具体措施设立的情况下使用的物质 需提供合适的
充足的说明才能授权，当申请时（第
4
条），最后的原
料和物件 需满足第三条的要求。

Article 9
Application for authorisation of a new substance
1. To obtain the authorisation referred to in Article 8(1),
8