Latest revision date (dd/mm/yyyy): 01/10/2021

Packaging

Packaging marketed within the EU must comply with the general requirements which aim at
protecting the environment, as well as with the specific provisions designed to prevent any risk to
the health of consumers.

Directive 94/62/EC (CELEX 31994L0062) defines 'packaging' as every product made of any
material of any nature to be used for the containment, protection, handling, delivery and
presentation of goods, from raw materials to processed goods, from the producer to the user or the
consumer. 'Non-returnable' items used for the same purposes are also considered to constitute
packaging. Annex I of the Directive contains a list of illustrative examples of 'packaging' and 'non-
packaging' products according to criteria set out by Article 3.

Hence, this type of products are affected by:

General requirements related to packaging and packaging waste

Specific provisions related to package sizing
Specific rules on nominal quantities for prepacked products
Specific rules for materials and articles intended to come into contact with foodstuffs
Specific rules for single-use plastics

General requirements related to packaging

and packaging waste
All packaging placed on the EU market, including packaging designed for industrial, commercial
and domestic purposes, must comply with the essential requirements on the composition and the
heavy metals limits specified in Directive 94/62/EC (CELEX 31994L0062), aiming at minimising the
impact of packaging waste on the environment.

The essential requirements which are set forth in Annex II to the Directive relate to:

Waste reduction by minimising the weight and/or volume of packaging;

Minimising the presence of substances considered to be noxious or hazardous;
Nature and conditions for packaging to be reused;
Recovery of packaging by material recycling and/or composting and/or energy recovery.

Besides these mandatory provisions, imports into the EU of packaging made of wood and other
plant products may be subject to phytosanitary measures established by Directive 2000/29/EC
(CELEX 32000L0029). Regulation (EU) 2021/127 (CELEX 32021R0127) sets out specific
requirements for the introduction into the Union territory of certain products listed in Annex for
Belarus, China and India.

In relation to wood packaging, the provisions introduced by Directive 2004/102/EC (CELEX

32004L0102) establish that wood packages of any type (cases, boxes, crates, drums, pallets, box
pallets and other load boards, pallet collars, etc.) shall go through one of the approved treatments
specified in Annex I to FAO International Standard for Phytosanitary Measures No. 15 and shall bear
the corresponding mark as specified in Annex II.
Companies responsible for placing packaging on the EU market must ensure that the essential
requirements are met. However, packaging is presumed to comply with these requirements if the
packaging comports with harmonised standards that are first adopted by European Committee for
Standardisation (CEN), and then approved and published by the European Commission. Nowadays,
six CEN standards have been published in the Official Journal.

The heavy metal limits apply to cadmium, mercury, lead and hexavalent chromium. The total level
of these metals in packaging or packaging components must not exceed 100 parts per million
(ppm). Packaging entirely made of lead crystal glass is exempted from the application of heavy
metal concentration levels.

Packaging must bear the appropriate marking on the packaging itself or on a label, in particular,
the nature of the packaging materials used must be indicated. Decision 97/129/EC (CELEX
31997D0129) establishes a Packaging Material Identification System to facilitate identification and
classification of packaging materials.

Market surveillance
Each Member State is responsible to designate one or more market surveillance authorities or any
other authority in their territory as the authorities in charge of controlling that the products
entering the Union market meet the requirements of the applicable rules in accordance with the EU
market surveillance framework laid down in Regulation (EU) 2019/1020 (CELEX 32019R1020). Each
Member State shall inform the Commission and the other Member States of its market surveillance
authorities and the areas of competence of each of those authorities.

Products complying with the general and specific requirements exposed before, enjoy free
circulation within the EU. However, in case a Member State ascertains that a product does not
comply with the requirements of the Directive, the competent authority of the Member State shall
forbid its placing on the market, restrict the free movement, or even withdraw the product from the
market where other corrective measures have failed.

The Member State shall inform the Commission and the other Member States of any measure
adopted, indicating the grounds for its decision.

List of applicable legislation

Specific provisions on package sizing

Certain prepackaged products shall only be placed on the market provided the nominal quantity
and capacity of the container fits into one of the sizes permitted by the EU legislation.

The labelling must indicate the volume in the case of liquid products and the weight in the case of
other products. The label of the prepacked product must also bear the weight and volume
indications used in trade practice or comply with the national regulations of the destination
country.

The packaging of these goods must bear specific inscriptions and markings such as the
identification of the packer, the person responsible for the packing or the importer established in
the EU, and the EEC mark, a small 'e', that must be placed in the same field of vision as the
indication of the nominal volume or weight of the contents.

This EEC marking symbolises the conformity with the metrological requirements laid down by
Directive 76/211/EEC (CELEX 31976L0211), in order to ensure that consumers get indeed the
quantity indicated on the packaging.
Specific rules on nominal quantities for
prepacked products
Directive 2007/45/EC (CELEX 32007L0045) establishes the range of nominal quantities for
prepacked products. According to this scheme:

Member States shall ensure that products listed in section 2 of the Annex to Directive
2007/45/EC (CELEX 32007L0045) and put up in prepackages in the intervals listed in section 1
of the Annex, are placed on the market only if they are prepacked in the nominal quantities
listed in section 1.
Aerosol dispensers shall indicate the nominal total capacity of the container, avoiding any
confusion with the nominal volume of the contents. Such dispensers will not need to be
marked with the nominal weight of their contents.
The nominal quantities listed in section 1 of the Annex shall apply to each individual
prepackage when two or more individual prepackages make up a multipack, as well as to the
prepackage when it is made up of two or more individual packages which are not intended to
be sold individually.

However, in accordance with the Regulation (EU) 2019/787 (CELEX 32019R0787) single distilled
shochu, produced by pot still and bottled in Japan, may be placed on the Union market in nominal
quantities of 720 ml and 1800 ml.

List of applicable legislation

Specific rules for materials and articles

intended to come into contact with
foodstuffs
All materials and articles intended to come into contact with foodstuffs, including packaging
materials and containers, must be manufactured so that they do not transfer their constituents to
food in quantities that could endanger human health, change the composition of the food in an
unacceptable way or deteriorate the taste and odour of foodstuffs.

Annex I of Regulation (EC) 1935/2004 (CELEX 32004R1935) on materials and articles intended to
come into contact with food establishes a list of materials and articles which may be subject to
specific measures related to authorised substances, special conditions of use, purity standards,
etc.

This Regulation also lays down that these products will be labelled 'for food contact' or shall bear
the symbol with a glass and fork.

Regulation (EC) 2023/2006 (CELEX 32006R2023) lays down the rules on good manufacturing
practice (GMP) for the groups of materials and articles intended to come into contact with food
listed in Annex I to Regulation (EC) 1935/2004 (CELEX 32004R1935) and combinations of those
materials and articles or recycled materials and articles used in their manufacturing process.
According to this Regulation, the application of printing inks to the non-food contact side of a
material or article is subject to specific rules.

Furthermore, and following the scope of both Regulations above mentioned, several EU
Regulations have laid down specific conditions applicable to the placing on the EU market of plastic
materials and articles intended to come into contact with food:
 Recycled plastics used to manufacture materials and articles intended for food contact shall
be obtained only from processes authorised by the Commission following a safety assessment
performed by the European Food Safety Authority (EFSA) according to Regulation (EC)
282/2008 (CELEX 32008R0282). The recycling process shall also be managed by a quality
assurance system (QAS) that should meet the requirements laid down in the Annex of
Regulation (EC) 2023/2006 (CELEX 32006R2023).
Only the substances included in the Union list of authorised substances set out in Regulation
(EU) 10/2011 (CELEX 32011R0010) may be used for the manufacture of these products.
Plastic materials and articles complying with Regulation (EU) 10/2011 (CELEX 32011R0010)
before the entry into force of Regulation (EU) 2020/1245 (CELEX 32020R1245) and which
were first placed on the market before 23 March 2021 may continue to be placed on the
market until 23 September 2022 and remain on the market until the exhaustion of stocks,
according to Regulation (EU) 2020/1245 (CELEX 32020R1245) that amends and corrects
Regulation (EU) 10/2011 (CELEX 32011R0010).
According to the same Regulation, the marketing and importation into the Union of plastic
materials and articles intended to come into contact with foodstuffs containing Bisphenol A
(BPA) is restricted since, BPA is prohibited in the manufacture of polycarbonate baby bottles.
Polyamide and melamine plastic kitchenware originating in or consigned from China and Hong
Kong shall be imported into the Member States only if the importer submits to the competent
authority for each consignment a declaration confirming that it meets the requirements
concerning the release of primary aromatic amines and formaldehyde laid down in Annex II to
Regulation (EU) 10/2011 (CELEX 32011R0010), according to Regulation (EU) 284/2011 (CELEX
32011R0284).

List of applicable legislation

Specific rules for single-use plastics

Directive (UE) 2019/904 (CELEX 32019L0904), applied from 3 July 2021, defines 'single-use
plastic product' as every product that is made wholly or partly from plastic and that is not
conceived, designed or placed on the market to accomplish, within its life span, multiple trips or
rotations by being returned to a producer for refill or re-used for the same purpose for which it was
conceived. Commission guidelines on single-use plastic products includes examples of what
is to be considered a single-use plastic product for the purposes of this Directive. It is also applies
to products made from oxo-degradable plastic and to fishing gear containing plastic.

It is important to note that, this Directive is a special law in relation to Directive 94/62/EC (CELEX
31994L0062). This means that in the event of conflict between those Directives, Directive (UE)
2019/904 (CELEX 32019L0904) should prevail within the scope of its application.

According to the Directive (UE) 2019/904 (CELEX 32019L0904) the placing on the market of the
single-use plastic products listed in Part B of the Annex and of products made from oxo-degradable
plastic is banned as of 3 July 2021. For other single-use plastic products, the Directive is limiting
their use addopting different measures:

Consumption reduction
Reduction in the consumption of single-use plastic products listed in Part A of the Annex through
awareness-raising measures addopted by Member States, that ensure a measurable quantitative
reduction in the consumption of the single-use plastic products by 2026.

Product requirements
Product requirements for single-use plastic products listed in Part C of the Annex. Those products
that have caps and lids made of plastic may be placed on the market only if the caps and lids
remain attached to the containers during their use. This requirement shall apply from 3 July 2024.

In relation to beverage bottles listed in Part F of the Annex, Directive includes specific target,
contain al least 25 % of recycled plastic by 2025 and at least 30 % of recycled plastic by 2030.

Marking requirements
Marking requirements for single-use plastic products listed in Part D of the Annex. Those products
placed on the market must bear a conspicuous, clearly legible and indelible marking on its
packaging or on the product itself informing consumers about the plastic content of the products,
appropiate waste management options for the products and the negative impact of littering the
products on the environment.

The harmonized marking specifications for position, size, design, format, colour and minimum
resolution of the marking can be found in Annex I for sanitary towels, tampons and tampon
applicators, Annex II for wet wipes, pre-wetted personal care and domestic wipes, Annex III for
tobacco products with filters and filters marketed for use in combination with tobacco products and
Annex IV for beverage cups to the Regulation (EU) 2020/2151 (CELEX 32020R2151).

Extended producer responsibility

In the line with the polluter-pays principle, the Directive introduces extended producer
responsability to cover the necessary costs of waste management and clean-up of litter as well as
the costs of awareness raising measures to prevent and reduce such litter. Those costs should not
exceed the costs that are necessary to provide those services in a cost-efficient way. Within this
scheme producers of the single-use plastic products listed in Part E of the Annex should cover the
following costs:

the costs of the awareness raising measures referred to in Article 10 of this Directive
regarding those products;
the costs of waste collection for those products that are discarded in public collection
systems, including the infrastructure and its operation, and the subsequent transport and
treatment of that waste;
the costs of cleaning up litter resulting from those products and the subsequent transport and
treatment of that litter; and
the costs of data gathering and reporting in accordance with point (c) of Article 8a(1) of
Directive 2008/98/EC (CELEX 32008L0098).

List of applicable legislation

Other information sources

European Committee for Standardisation (CEN): https://www.cencenelec.eu/about-cen/
European Food Safety Authority (EFSA): https://www.efsa.europa.eu/
Packaging Waste: https://ec.europa.eu/environment/topics/waste-and-recycling/packaging-
waste_en
Legal metrology: https://ec.europa.eu/growth/single-market/goods/building-blocks/legal-
metrology_en
Food contact materials:
https://ec.europa.eu/food/safety/chemical_safety/food_contact_materials_en
European Union Reference Laboratory for Food Contact Material (EURL-FCM):
https://ec.europa.eu/jrc/en/eurl/food-contact-materials/substance-database
EU guidance on conditions and procedures for the import of products originating in or
consigned from China and Hong Kong: https://ec.europa.eu/food/system/files/2016-
10/cs_fcm_legis_china_guidelines_import-polymide-melamine.pdf
European Organisation for Packaging and the Environment (EUROPEN): https://www.europen-
packaging.eu/
Packaging Recovery Organisation Europe (PRO EUROPE): https://www.pro-e.org/
Single-use plastics: https://ec.europa.eu/environment/topics/plastics/single-use-plastics_en
Marking specifications for single-use plastic products:
https://ec.europa.eu/environment/topics/plastics/single-use-plastics/sups-marking-
specifications_en
Market surveillance for products: https://ec.europa.eu/growth/single-market/goods/building-
blocks/market-surveillance_en