Regulatory ESSENTIAL



Regulatory ESSENTIALS - modular information package with all the essential information for compliant products in your target market. Conveniently read online at Product-Compliance-Portal ROGER WILLCO.

Food contact materials; food contact substances; food processing machinery; hygienic design of food processing machinery; hygienic design; hygienic sanitary design; product contact surfaces; cleaning; disinfection; dead spaces; bakery machines; grocery machines; meat; diary

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Scope: This ESSENTIAL describes conformity procedures for food contact materials (FCM), based on the Australia and New Zealand Food Standards Code and FSANZ guidances.

Stakeholders: Manufacturer, Importer
Legislation in force: Australia and New Zealand Food Standards Code, contains four chapters: 1) Introduction and standards that apply to all foods; 2) Food standards; 3) Food safety standards; and 4) Primary production standards. Attention: Chapters 3 and 4 apply only in Australia. Food Contact Substances defined under the Code are: - Food additives - Processing aids - Food Package 1.1.2—11 Definition of "used as a food additive, etc": Food additives are defined as substances added to food to perform one or more technological functions in the finished food. 1.1.2—13 Definition of "used as a processing aid". Processing aids include substances used to perform a technical purpose during food processing, but not in the finished food 1.1.2 Definition of "package": (a) means any container or wrapper in or by which food for sale is wholly or partly encased, covered, enclosed, contained or packaged; and (b) if food is carried or sold or intended to be carried and sold in more than one package—includes each package; and (c) does not include: (i) a bulk cargo container; or (ii) a pallet overwrap; or (iii) a crate and packages which do not obscure labels on the food; or (iv) a transportation vehicle; or (v) a vending machine; or (vi) a hamper; or (vii) a container or wrapper (including a covered plate, cup, tray or other food container) in which food is served in a prison, hospital or medical institution; or (viii) for Standard 2.9.5—a covered plate, cup, tray or other food container in which food for special medical purposes is served by a *responsible institution to a patient or resident. Standard 1.4.1 - Contaminants and natural toxicants (limits for metal/non-metal contaminants, natural toxicants, average and maximum levels of mercury in fish). - Reference: Schedule 19 Standard 3.2.1 Food Safety Programs This Standard is based upon the principle that food safety is best ensured through the identification and control of hazards in the production, manufacturing and handling of food as described in the Hazard Analysis and Critical Control Point (HACCP) system, adopted by the joint WHO/FAO Codex Alimentarius Commission, rather than relying on end product standards alone. This standard enables States and Territories to require food businesses to implement a food safety program based upon the HACCP concepts. The food safety program is to be implemented and reviewed by the food business, and is subject to periodic audit by a suitably qualified food safety auditor. Standard 3.2.2 - Food Safety Practices and General Requirements This Standard specifies process control requirements to be satisfied at each step of the food handling process. Some requirements relate to the receipt, storage, processing, display, packaging, distribution disposal and recall of food. Other requirements relate to the skills and knowledge of food handlers and their supervisors, the health and hygiene of food handlers, and the cleaning, sanitising, and maintenance of premises and equipment. Food Standards Australia New Zealand Act 1991 - describes the applicability of food regulatory measures Part 2 - The Authority Division 2 - Food regulatory measures Section 16 - Matters that may be included in standards and variations of standards (1) Standards, and variations of standards, developed by the Authority may relate to any of the following: - (a) the composition of food, including: (i) the maximum amounts of contaminants or residues that may be present in the food; and (ia) the maximum or minimum amounts of additives that must or may be present in the food; and (ii) its microbiological status and safety; and (iii) the method of sampling and testing the food to determine its composition; - (b) the production of food; - (c) the handling of food; - (ca) the prohibition of the sale of food: (i) either in all circumstances or in specified circumstances; and (ii) either unconditionally or subject to specified conditions; - (d) any information about food including labelling, promotion and advertising; - (e) the knowledge, skill, health and hygiene requirements for people handling food; - (f) the responsibilities of businesses that are handling food relating to any hygiene requirements in force under paragraph (e) for people involved in the business who are handling food; - (g) the responsibilities of businesses that are handling food to ensure that information in connection with hygiene requirements in force under paragraph (e) that is provided by individuals involved in the business and who are handling food remains confidential except in specified circumstances; - (h) the use of devices of a particular standard to measure the temperature of food; - (i) the design, construction, maintenance and cleanliness of: (i) premises (including fittings and fixtures) at which food is handled; or (ii) equipment (including single use items) used to handle food; or (iii) vehicles used to transport food; - (j) the information that a business that handles food may be required to give about the business to State or Territory authorities; - (k) restrictions on the premises at which, and the persons by whom, particular food may be sold or otherwise supplied; - (l) restrictions on the publications that may contain advertisements for particular food; - (m) requirements relating to animals and pests at premises in which food is handled, or in vehicles in which food is transported; - (n) the interpretation of other standards; - (o) the application of standards; - (p) such other public health matters relating to food as are prescribed. (2) Without limiting subsection (1), a standard may relate to: (a) a class of food generally; or (b) a particular brand of food.

Application national: Australia, Food Contact Materials, FSANZ

Countries: Image for AU Australia,  
Status: Published 2021-12-14 by Anette Dunkel-Reinboth and Michael Loerzer
Last change 2024-10-21 by Anette Dunkel-Reinboth: Link/Reference to other reference document(s), Food contact materials
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Scope of this ESSENTIAL
This ESSENTIAL describes conformity procedures for food contact materials (FCM), based on the Australia and New Zealand Food Standards Code and FSANZ guidances.'

Abbreviations
Here you will get a table

Important abbreviations which are special for this legislation or theme.

Analysis of regulatory requirements

Legislation in force for this PCT
Here you will get related hyperlink(s)

Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Legislation in force for this PCT
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(only reachable with additional ROGER WILLCO license)

Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Responsible actors
Here you will get textual information

Which actor(s) are responsible for compliance with the legal provisions: e. g. - economic operators (manufacturer, importer, distributor, fulfilment service provider), - user (commercial/industrial/professional), - user (private, consumer)?

Regulatory market access conditions for the actor(s)
Here you will get textual information

What are the main regulatory requirements (e. g. conformity assessment fulfilment of essential requirements of Annex I 2006/42/EC) prior placing on the market, importation and putting into service (brief description)

Penalty by this legislation
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What are the possible penalties (e. g. sales ban, fines) in the case of non-compliance?

Exemption clauses
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Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties
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E. g. by 2019 an Inter-Governmental Agreement (IGA) on governance of the Electrical Equipment Safety System (EESS) has been signed by Queensland, Victoria, Western Australia and Tasmania.

FTA/MRA status with EU
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Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority
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Name of the authority for approval, registration, market surveillance and/or enforcement

Market surveillance authority
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Name of the authority for market surveillance and/or enforcement

Link/Reference to other reference document(s)
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(only reachable with additional ROGER WILLCO license)

Link/Reference to other reference document(s)
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Hints
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Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Registration at related authority required?
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Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?
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[Yes/No]

Equipment authorization (approval process)

Approval process (conformity assessment procedure)
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Means each legally required approval process prior placing on the market, importation or putting into service

Conformance document(s) to show compliance to the authority
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(only reachable with additional ROGER WILLCO license)

e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Conformance document(s) to show compliance to the authority
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e. g. SDoC, technical documentation (for 10 years), filled-in approval forms (e. g. ACMA in AUT)

Is a factory inspection legally required
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Hint to voluntary certification scheme
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If a important voluntary certification schemes exists, one link will be given. Important voluntary schemes are for example: UL, CSA, VCCI (Japan)

Hints
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Specific recommendations, information or most common mistakes

Hints
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

Specific recommendations, information or most common mistakes

Testing & Standards

Specific requirements for testing
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e. g. is an accredited test lab. mandatory, limits, test samples, product description

General information to the application of standards
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e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"

National Standardisation Organisation
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Link to organisation

Is in-country testing legally required?
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Acceptance of foreign test reports
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Hints
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(only reachable with additional ROGER WILLCO license)

Specific recommendations, information or most common mistakes

Regulatory labelling, markings and user information

Regulatory label (mandatory)
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e. g. product label

Regulatory e-labelling allowed?
Here you will get textual information

e. g. put the regulatory information and labels in a software menu

Required information on the product and/or packaging
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e. g. address of the manufacturer/importer, serial number

User instructions language(s)
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Regulated by the legal provisions

Hints
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Specific recommendations, information or most common mistakes


Code, ContinentAUS, Australia
Economic AreaAPEC
Official LanguageAustralia does not have an official language, the main language of Australia is definitely ENGLISH. The written English used is closely related to the English of Britain, although there are a few differences in spelling.
Standard InstituteStandards Australia | https://www.standards.org.au/
HS CodememberYes






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