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Non-prescribed goods

European Union

Considerations prior to updating of establishment details (added 3 June 2021)

The following should be considered prior to updating establishment details:

  • When an establishment notifies the Department of an administrative change (that is, a change of occupier, company name, address, or in some instances product specific changes), the Department amends the establishment record in the system.
  • The establishment's amended details will appear on applicable export documentation including health certification from the date that the Department amends the establishment record
  • When relevant changes are made to an establishment's details, the Department will advise trading partners that maintain establishment lists of the change of details; however, the Department is unable to guarantee a timeframe as to when trading partners will update the establishment's overseas listing details they maintain. This means that there may be a period in which export certification issued by the Department does not match the trading partner's official published listing, which may result in clearance issues at the port of entry.
  • Establishments should be aware that their ability to export to some countries may be impacted during this transition period and may include issues with goods in transit.
  • Exporters and manufacturers are encouraged to check that their establishment's details are recorded accurately where they appear on trading partners' lists and to contact the Department if errors are found.
Table 1: EU member states, dependencies and other European countries that adopt EU requirements

Relationship with the EU

Countries and territories

Member States

Austria (AT), Belgium (BE), Bulgaria (BG), Croatia (HR), Cyprus (CY), Czech Republic (CZ), Denmark (DK), Estonia (EE), Finland (FI), France (FR), Germany (DE), Greece (GR), Hungary (HU), Italy (IT), Latvia (LV), Lithuania (LT), Luxembourg (LU), Malta (MT), Netherlands (NL), Poland (PL), Portugal (PT), Republic of Ireland (IE), Romania (RO), Slovakia (SK), Slovenia (SI), Spain (ES), Sweden (SE)

Note
These Member States adopt all EU requirements for products that have been harmonised throughout the EU and may have additional requirements for products that are not yet harmonised.

EU dependencies

  • France: French Guiana (Cayenne) (GF), Guadeloupe (GP), Mayotte (YT), Martinique (MQ), Reunion Island (RE), and St Pierre and Miquelon (PM)
  • Portugal: Azores (PT), Madeira (PT)
  • Spain: Canary Islands (ES)
Note
These countries adopt all EU requirements for products that have been harmonised throughout the EU and adopt requirements of the country they are a dependency of for products that are not yet harmonised.

Other European countries that adopt EU requirements

Faroe Islands (FO), Iceland (IS), Liechtenstein (LI), the Republic of North Macedonia (MK), Norway (NO), United Kingdom (GB) (including Gibraltar (GI) and the Channel Islands) and Switzerland (CH)

Note
These countries may not adopt all EU requirements for products that have been harmonised throughout the EU.

Northern Ireland Protocol

Northern Ireland (GB)

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General conditions

1. General conditions for edible non-prescribed goods

1.1. Prohibited

Unless specified in the specific goods list below, the Department is not aware of any prohibited edible non-prescribed products, including apiculture products for this market.

1.2. Conditions

Government certification

Australian producers and exporters of animal products should understand and adhere to the requirements under Commission Implementing Regulation (EU) 2020/2235 concerning official certificates for certain animals and goods. In particular, the export certificate must be issued before the consignment departs Australia (Article 5).

Registration and Listing

Establishments that export edible products to the EU must be export registered with the Department and included on the lists on the European Commission's (EC) website.

Packaging requirements

Ban on use of PFAS in paper and cardboard food contact materials

Denmark has banned paper and cardboard food contact material containing per- and polyfluoroalkyl substances (PFAS) (for example, from recycled paper and cardboard or from printing inks), unless the food contact materials are separated from the food by a functional barrier which prevents the migration of PFAS substances to the food.

The ban came into effect from 1 July 2020.

Food processors may be asked by importers to demonstrate that materials in contact with foods such as non-prescribed goods do not contain any PFAS or if they do, are used with a functional barrier to ensure no migration to food can occur.

While Denmark is currently the only EU member state to take action on use of PFAS in food contact materials, it is noted that individual member states and the EU as a whole are considering risks associated with human exposures to PFAS and similar proposals may be made at a later date in other jurisdictions.

The Department encourages all exporters to work with their importer to ensure that product meets the current importing country requirements.

Labelling requirements

Exporters should be aware of European Union (EU) labelling requirements, including allergen statement requirements, as detailed in EU Regulation No 1169/2011.

Conditions

The European Commission (DG SANTE) has adopted a regulation setting a limit for the presence of trans fatty acids in food (two grams of industrially produced trans fat per 100 grams of fat). The new limit will apply to food intended for the final consumer and food intended for supply to retail in the European Union from 2 April 2021.

Residues

Export Destination Residues Warning – EU residue standards

Maximum residue limits (MRLs) or import tolerances for residues of specific agricultural and veterinary chemicals approved for use in Australia may not exist in the EU or may be established at levels lower than those established in Australia. Respective maximum limits (MLs) for contaminants may also vary between the EU and Australia.

Food business operators who are eligible to export to the EU should note that:

  1. a) These differences can be interrogated case-by-case by considering the EU standards (here for pesticides, veterinary drugs and contaminants) and the Australian standards (here for pesticides & veterinary drugs and here for contaminants).
  2. b) Any detection of a residue above the EU MRLs/MLs (if applicable) at the EU border would result in rejection of the consignment and trigger an information, alert and/or border rejection notification in the (public) EU Rapid Alert System for Food and Feed (RASFF).

2. General conditions for inedible non-prescribed goods

2.1. Prohibited

In accordance with Article 25, Chapter VIII of Regulation (EU) No 142/2011, beeswax in the form of honeycomb is a prohibited import into the European Union.

The Department is not aware of any other prohibited inedible non-prescribed goods, including inedible apiculture products for this market.

2.2. Conditions

Apiculture by-products

Establishments that produce/process some inedible apiculture products to the EU must be listed on the European Commission's (EC) website. Listing of new establishments that produce/ process inedible products for export to the EU generally takes up to two months.

Apiculture by-products are defined in Regulation (EU) No 142/2011 as honey, beeswax, royal jelly, propolis or pollen not intended for human consumption.

Beeswax in the form of honeycomb

In accordance with Article 25, Chapter VIII of Regulation (EU) No 142/2011, beeswax in the form of honeycomb is a prohibited import into the European Union.

Apiculture by-products intended exclusively for use in apiculture (bee keeping)

Apiculture by-products must have been produced in accordance with the requirements of Regulation (EU) No 142/2011 and (EC) No 1069/2009.

For the English only certificate, use M453 (Manual only)

For the English/French bilingual certificate, use M454 (Manual only)

For the English/German bilingual certificate, use M455 (Manual only)

Certification attestations

I, the undersigned official veterinarian, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a) and in particular Article 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Annex XIV, Chapter II thereof, and certify that the apiculture by-products described above:

come from an area where the diseases listed below are officially notifiable and which is not subject to any restrictions associated with:

  1. American foulbrood (Paenibacillus larvae)
  2. Acariosis (Acarapis woodi (Rennie))
  3. Small hive beetle (aethina tumida)
  4. Tropilaelaps mites (Tropilaelaps spp.)

have been:

Either subjected to a temperature of -12 degrees Celsius or lower for at least 24 hours,
OR
In the case of wax, refined or processed in accordance with processing method 1-2-3-4-5-7 (2), as set out Chapter III of Annex IV to Regulation (EU) No 142/2011.

For beeswax, other than beeswax in the form of honeycomb, exported for purposes other than feeding to farmed animals

  • The beeswax must only be derived from Category 3 materials referred to in Article 10(e) of Regulation (EC) 1069/2009.
  • The beeswax must have been produced in accordance with the requirements of Annex XIV, Chapter II, Section I, Table 2, Row 10. of Regulation (EU) No 142/2011.
  • The beeswax must be refined before export,
  • OR
  • It must have been processed in accordance with processing methods 1 to 5 or 7, as set out in Annex IV, Chapter III of Regulation (EU) No 142/2011 before export.

Other inedible non-prescribed goods

Compliance with relevant Australian domestic requirements. The Department is unaware of any certification requirements for this market.

Specific goods

Edible apiculture products

1. Preconditions for market access

1.1 Import permit

Exporters are not required to obtain an import permit.

1.2 Listing and audit
Listing and audit procedureRequired?
AuditCurrent certificate of compliance for a Hazard Analysis and Critical Control Points (HACCP)-based food safety management program
Listing — Department's Establishment Register (ER)Yes
Listing — European Commission's (EC) websiteYes

Establishments that produce/process edible apiculture products to the EU must be listed on the European Commission's website. Listing of new establishments generally takes up to three months. Refer to the current Establishment Lists.

In order to be listed on the European Commission's website, Australian producers and packers of edible apiculture products must be listed with the Department as EU eligible and have a current certificate of compliance for a HACCP-based food safety management program.

1.3 Prohibited products

The Department is not aware of any prohibited edible apiculture products for this market.

2. Documentation requirements

2.1 Government certification

The following export certificates are available as a manual only certificate. These are completed and printed manually and then submitted to the Department’s regional offices for signature.

Language
Certificate number
English onlyEUHGB

To request certification for EU Member countries that require bilingual certificates, exporters are advised to contact the Department through ExportStandards.agriculture.gov.au

Australian producers, packers and exporters of edible apiculture should understand and adhere to the requirements under Commission Implementing Regulations (EU) 2020/2235 and 2022/36 concerning official certificates for certain animals and goods. In particular, the export certificate must be issued before the consignment departs Australia (Article 5).

The following document provides instructions on how to complete certificate number EUHGB:

2.2 Supporting documents and exporter declarations
Australian honey only

A manufacturer's declaration is required to confirm that the honey is 100% Australian origin and unblended with imported honey.

Blended honey

Only honey originating from countries eligible to export to the EU, as outlined in Decision 2019/525/EU (and subsequent legislation amending Decision 2011/163/EU), may be used to blend honey destined for export to the EU. This requirement also applies to honey that is imported to Australia for repackaging and then exported to the EU.

An exporter's declaration is required to confirm the honey for export is either Australian honey blended with imported honey or is 100 per cent imported honey.

To obtain an export certificate to export to the EU honey that has been blended with honey from third countries the exporter must provide certification or a letter on official letterhead from the agricultural authorities of the third countries with the following attestations:

I, the undersigned, declare that I am aware of the relevant requirements of Regulation (EC) No 178/2002 of the European Parliament and of the Council, Regulation (EC) No 852/2004 of the European Parliament and of the Council, Regulation (EC) No 853/2004 of the European Parliament and of the Council, Regulation (EU) 2017/625 of the European Parliament and of the Council, and Council Directive 2011/110/EC and hereby certify that honey and other apiculture products described in Part I were produced in accordance with these requirements, in particular that they:

  1. (a) come from (an) establishment(s) that has(ve) been registered and implement(s) a programme based on the hazard analysis and critical control points (HACCP) principles in accordance with Article 5 of Regulation (EC) No 852/2004 and regularly audited by the competent authority;

  2. (b) have been handled and, where appropriate, prepared, packaged and stored in a hygienic manner in accordance with the requirements of Annex II to Regulation (EC) No 852/2004;

  3. (c) fulfil the guarantees covering live animals and products thereof provided by the residue plans submitted in accordance with Article 29 of Council Directive 96/23/EC, and honey is listed in Commission Decision 2011/163/EU for the concerned country of origin;

  4. (d) have been produced under conditions guaranteeing compliance with the maximum residue levels for pesticides laid down in Regulation (EC) No 396/2005 of the European Parliament and of the Council, and the maximum levels for contaminants laid down in Commission Regulation (EC) No 1881/2006; and

  5. (e) in the case of honey, conforms to the product description and composition criteria as defined in Annexes I and II to Council Directive 2001/110/EC and, in particular, does not contain any added food ingredient, including food additives or extraneous sugars, with the exception of honey.

3. Other requirements

Australian producers, packers and exporters of edible apiculture products must understand and implement provisions set out in the following European regulations:

  • (EC) No. 2002/178 relating to general food laws, including traceability.
  • (EC) No. 2004/852 relating to food hygiene.
  • (EC) No. 2004/853 relating to specific rules for food of animal origin.

Edible apiculture products must have been handled and, where appropriate, prepared, packaged and stored in a hygienic manner in accordance with the requirements of Annex II to Regulation (EC) No 852/2004.

Exporters should be aware of EU labelling requirements, including allergen statement requirements, as detailed in EU Regulation No 1169/2011.

Edible apiculture products exported to the EU must comply with European Directive 96/23/EC, which sets EU standards for residues of agricultural and veterinary chemicals and environmental contaminants. The Department's National Residue Survey honey program gives the EU adequate assurance of the compliance of Australian edible apiculture products. Edible apiculture products must be solely of Australian origin or blended with products imported from countries that meet the EU's requirements for residue testing.

Each year, Australia and other countries that export animal products to the EU submit their residue monitoring programs for assessment. The Commission then publishes its results of its assessment. This decision is amended and placed on the EUR-Lex website periodically. Decision 2015/1338/EU is in force and includes a list of countries that have been accepted as meeting the EU’s residue requirements and whose honey could be included in blended products for export to the EU.

4. Exemptions granted by the European Union

Products of animal origin, composite products, products derived from animal by-products, plants, plant products and other objects which form part of passengers’ personal luggage and which are intended for personal consumption or use, are exempted from official controls at EU border control posts provided that their combined quantity does not exceed a weight limit of 2 kg, as written in the Commission Regulation (EC) No 2019/2122.

Composite Products

Composite products are defined as products containing both products of plant origin and products of animal origin such as chocolate bars, biscuits, soups, frozen cakes and pies.

Commission Delegated Regulation (EU) 2019/625 stipulates the following categories for composite products:

  1. (1) non shelf stable composite products;
  2. (2) shelf stable composite products that contain meat products; and
  3. (3) shelf stable composite products that do not contain meat products.

A non shelf-stable composite product needs to be transported or stored under controlled temperature. It is not the case for shelf-stable composite products which can be kept at ambient temperature.

All processed products of animal origin (meat, dairy, eggs and fish), regardless of their percentage as an ingredient in the product, are required to be sourced from EU listed establishments to be eligible for import.

1. Preconditions for market access

1.1 Import permit

Exporters are not required to obtain an import permit.

1.2 Listing and audit
Listing and audit procedureRequired?
AuditCurrent certificate of compliance for a Hazard Analysis and Critical Control Points (HACCP)-based food safety management program
Listing — Department's Establishment Register (ER)Yes
Listing — European Commission's (EC) websiteYes

Establishments that produce/process composite products to the EU and those establishment from which the animal origin ingredients are sourced must be listed on the European Commission's website. Listing of new establishments generally takes up to three months.

The processing establishment must be listed under Section IV of Animal By-products: Processing Plant. Refer to the current Establishment Lists.

In order to be listed on the European Commission's website, Australian producers and packers of composite products must be listed with the Department as EU eligible and have a current certificate of compliance for a HACCP-based food safety management program.

1.3 Prohibited products

Please note Australia does not currently maintain an EU approved residue plan for porcine or poultry and therefore is not permitted to export those commodities or products containing these ingredients to the EU. Australia does maintain EU approved residue plans for meat, dairy and fish products and can export these products, and products containing these ingredients, to the EU.

2. Documentation requirements

2.1 Government certification

The following export certificate is available as a manual only certificate.

This is completed and printed manually and then submitted to the department's regional offices for signature.

Certificate number
Title
​Language
M492Official Certificate for the Entry into the Union of Not Shelf-Stable Composite Products and Shelf-Stable Composite Products, containing any quantity of meat products except gelatine, collagen and highly refined products, and intended for human consumption​English
​M492A
​Official Certificate for the Transit Through the Union to a Third Country either by Immediate Transit or After Storage in the Union of Not Shelf-Stable Composite Products and Shelf-Stable Composite Products, Containing any Quantity of Meat Products and Intended for Human Consumption
​English

The attestations on M492 and M492A are crossed out based on the internationally recognised animal disease status of Australia and access and prohibitions on Australian commodities entering the EU. Refer to notes under 1.3 above, on prohibited products.

Manufacturer's Private Attestation

This Attestation is for shelf stable composite products that do not contain meat products. 

It is required to be prepared and signed by the representative of the importing food business operator (in case of exemption from control at the border, it may accompany the products only at the time of the placing on the market)

The Private attestation is found in Annex V of Commission Implementing Regulation (EU) No 2020/2235. It is not an Australian Government document.

3. Other requirements

4. Exemptions granted by the European Union

Edible Tallow

1. Preconditions for market access

Establishments that export edible products to the EU must be export registered with the Department and included on the lists on the European Commission's (EC) website.

2. Documentation requirements

For exports of rendered animal fats and greaves (inclusive of edible tallow) to the EU, use certificate template EUET (manual only). This certificate is titled, "Health Certificate For The Entry Into The Union Of Meat Products Intended For Human Consumption, Including Rendered Animal Fats And Greaves, Meat. Extracts And Treated Stomachs, Bladders And Intestines Others Than Casings, That Are Not Required To Undergo A Specific Risk-Mitigating Treatment."

Please open the link below for instructions on how to complete the front page for Certificate Number EUET.

3. Other requirements

4. Exemptions granted by the European Union

Raw materials for the production of gelatine and collagen

1. Preconditions for market access

Establishments that export edible products to the EU must be export registered with the Department and included on the lists on the European Commission's (EC) website.

2. Documentation requirements

For the export of untreated raw materials for the production of gelatine and collagen intended for human consumption to the EU, use certificates template M022 (manual only).  This certificate is titled, "Health Certificate For The Entry Into The Union Of Raw Materials For The
Production Of Gelatine And Collagen Intended For Human Consumption."

3. Other requirements

4. Exemptions granted by the European Union

Treated raw materials for the production of gelatine and collagen

1. Preconditions for market access

Establishments that export edible products to the EU must be export registered with the Department and included on the lists on the European Commission's (EC) website.

2. Documentation requirements

For the export of treated raw materials for the production of gelatine and collagen intended for human consumption to the EU, use certificate template M589 (manual only).  This certificate is titled, "Health Certificate For The Entry Into The Union Of Treated Raw Materials For The
Production Of Gelatine And Collagen Intended For Human Consumption."

3. Other requirements

4. Exemptions granted by the European Union

Processed edible collagen to the EU

1. Preconditions for market access

Establishments that export edible products to the EU must be export registered with the Department and included on the lists on the European Commission's (EC) website.

2. Documentation requirements

For the export of processed edible collagen to the EU, use certificate template Z995 (manual only) titled, “Official Certificate for the Entry into the Union of Collagen intended for Human Consumption.”

3. Other requirements

4. Exemptions granted by the European Union

Latest updates

03/11/2022 - Updated Information on honey, composite products, edible tallow and others.
22/04/2022 - Added warning regarding existing EU residues requirements (section 1.2).
09/08/2021 - Packaging requirements - Ban on use of PFAS in paper and carboard food contact materials (Section 1.2).
16/09/2020 - Added apiculture product requirements.
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Last updated: 3/11/2022 4:14 PMCreated: 17/08/2020 9:32 AM