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French Packaging Council – All Rights Reserved – March 2015 1 Packaging and Product Traceability

Packaging and Product Traceability · Traceability can cover the entire supply chain of the product/packaging pairing (knowing on time where the products/packaging are, managing the

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Page 1: Packaging and Product Traceability · Traceability can cover the entire supply chain of the product/packaging pairing (knowing on time where the products/packaging are, managing the

French Packaging Council – All Rights Reserved – March 2015 1

Packaging and Product Traceability

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Foreword: A Message from the Chairman Traceability is a major trend nowadays. Citizens and consumers are eager for knowledge. They want to know everything. The internet is another reason for this ever-growing trend since it enables people to react faster than our forbearers ever could. Everything has become a leitmotiv! We know that the major and persisting trends in our society undoubtedly have an impact on our living conditions and the products we use. Using products implies using packaging as well. As a consequence, traceability has an impact on packaging, an impact that will be greater in the near future. That is why the CNE (the French Packaging Council) wants this topic, which goes well beyond packaging, to be broadly discussed. Firstly, as usual, we need to define what traceability means in our line of work. Then, we will analyse it through relevant and complimentary points of view.

Traceability regarding users and consumers’ health and safety means informing them on the substances contained in the product (including in the packaging)/, allergies/ lot numbers/ recall procedures/ tamper-evident technology/legally responsible person/ shelf life/ safety guidelines/ precautions for use/ information on recycling. This type of traceability must guarantee that the product is perfectly safe to use, from its purchase to the final phase of its lifecycle.

Traceability regarding the country of origin, place of provenance and logistics provides information on the origin of the substances/ country/place of production and storage/ the type of transport/ the follow-up of dates, places and storage conditions (temperatures, pressure, humidity)/ the impact on the environment. This type of traceability should help the consumer/user understand how the product was produced and transported, so that, if need be, the informed decision they make as to whether or not to buy to the product is not solely based on the price (for example: I do not want to buy strawberries produced in Chili).

Traceability regarding counterfeiting gives assurance that the product does come from the brand that is indicated on the product. This traceability must guarantee that the product is not counterfeit.

In fine, we need to be able to answer the simple questions below:

- Why do we need traceability (regulation, voluntary initiative, etc.)? - How can it be applied? How can it be formalised? - What does it mean for packaging in the future?

Michel Fontaine Chairman of CNE

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Summary Traceability is a regulatory requirement for numerous products. With this document, the French Package Council (CNE) shows how important packaging is as a tool for traceability because, on the one hand, traceability is carried out through packaging, and on the other hand, because packaging is often the only tool by which traceability can be ascertained. Using a couple of examples, CNE shows that traceability has several dimensions. Traceability can be upstream (the origin of the packaging, the resources used to make it, the type of life cycle, etc.). It can be downstream (user/consumer information on the type of product, measures against counterfeit or falsified products, etc.). Traceability can cover the entire supply chain of the product/packaging pairing (knowing on time where the products/packaging are, managing the flows, calling the products back, managing logistics, etc.) in a downward manner (in order to find the product location, especially in case of a recall/withdrawal) or in an upward manner (in order to trace the origin and characteristics of a product, especially in case of quality issues). As proved by these examples, packaging is a crucial tool for traceability, all the more so since it is required by law itself (European Directive 94/62/EC), especially when it comes to performance criteria, such as consumer information, safety and, even, logistics. Considering its purpose, traceability may require the use of techniques or the association of different materials. The French Package Council indicates the sources of information and the best practices in terms of design so that the packaging retains its traceability function while taking into account its real recyclability.

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Table of contents

Foreword: A Message from the Chairman page 2

Summary page 3

1. Context/Purpose of Traceability page 5

2. Definitions page 6

3. Regulation page 8

4. Implementing Traceability page 10

5. Traceability and the Environment page 14

6. Some Examples of Traceability page 16

7. Appendices page 24

8. Acknowledgements page 31

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1. Context and Purpose of Traceability Context According to WHO1, one out of two medicines sold on internet websites in 2012 was counterfeit. This counterfeit medicine business is worth 75 billion euros2 worldwide. In 2006, an Ipsos study was already pointing out that counterfeit food represented 10% of all seized counterfeit products. Beyond counterfeiting, recent events show that traceability is necessary in order to trace the product and its components at each step of the supply chain. The use of packaging to trace the product is one of the tools guaranteeing the global safety of packaged products and consumers. It is also one of the performance criteria that must be analysed within the context of standard NF EN 13428.

Purpose Regarding traceability, packaging must guarantee: Traceability regarding consumer and user health and safety

Give information to the consumer and end user (on the origin, the provenance, the date of durability, etc.),

Preserve the integrity of the package/product pairing against any violation, Protect the consumer, the user (safety), Abide by regulatory requirements when, by law, the packaged product must be traced, Understand the impact of raw materials on processes/products, Use a potential competitive advantage: ‘assert traceability as one of the company’s core

values’. Traceability regarding origin-provenance-logistics

Register the history of the product life cycle, Be able to ensure the product withdrawal/recall, Guarantee better control of logistic operations and follow transport and delivery

operations in real-time, Manage remnants and losses at best, Guarantee traceability control, Optimise quality management of products and processes.

Traceability regarding counterfeiting

Prove the authenticity of the product: fight against counterfeiting Establish liability.

1 http://www.who.int/mediacentre/factsheets/fs275/en/

2 Institute of Research Against Counterfeit Medicines (IRACM)

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2. Definitions

2.1 Traceability Traceability is an obligation, which can be directly or indirectly required by regulation. It covers almost all types of products (food products, cosmetic products, household products, pharmaceutical products, toys, etc.). Traceability is a way to ensure that all products on the market are safe for use. Here, the CNE offers a number of definitions taken from standards and regulations.

The ability to retrace the history, use or location of a product by the means of recorded identification.3

The ability to trace the history, application or location of that which is under consideration with an additional clause which states that “when relating to products, traceability can be specifically linked to the origin of materials and parts, the processing history, and the distribution and location of the product after delivery.” 4

The ability to trace and follow a material or article through all stages of production, processing and distribution.5

The ability to trace and follow foodstuff, feed, food-producing animals or substances intended to be, or expected to be, incorporated into a food or feed, through all stages of production, processing and distribution.6

Traceability can be defined through the flow of products:

Upstream traceability means all the procedures and tools implemented before another player takes part in the production chain. It helps identify all the suppliers and raw materials involved. It is also called “N-1 traceability”.

Downstream traceability is all the procedures and tools implemented once the product is delivered to a third party. It helps identify all the clients and products provided. It is also called “N+1 traceability”.

Internal traceability represents all the information that helps define all the steps undertaken between the reception of the raw materials and the manufacturing of the end product.

3 NF EN ISO 8402 standard 4 ISO 9000:2000 standard 5 Regulation (EC) No 1935/2004 6 Codex Alimentarius and the European regulation EC 178/2002

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2.2 Packaging See definition in chapter7, appendices page 24 It is important to identify the core elements of the performance criteria defined in standard EN 13428 ‘Prevention by Source Reduction’ as these parameters entail the management of traceability. Traceability is then at the core of criteria such as the protection of the product, logistics, information and safety. These performance criteria generally go hand in hand with requirements regarding the product, its transport, and the protection of the consumer/user. They remind us that packaging has a part to play in the way companies manage traceability.

Source: CNE

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3. Regulation CNE gives a few examples of regulatory laws concerning traceability (for additional information, see chapter 7, appendices).

Reference EU regulation French regulation

Related standards

EU alert system

All types of products

Directive 2001/95 on general product safety

French Consumer Code Art. L221-1-4 Marketed products must meet security requirements and entities must transmit information on the risks linked to this type of product.

HACCP ISO 9000

RAPEX: All products with the exception of foodstuff, Pharmaceutical products and medical devices

Food products

Regulation 178/2002: law laying down the general principles and requirements of food law. Framework law of the Hygiene Package Regulation 1169/2011 on the provision of food information to consumers regarding consumer safety (origin labelling) Directive 2011/91on indications or marks identifying the lot to which a foodstuff belongs Regulation 1830/2003 concerning the traceability of genetically modified organisms Commission Implementing regulation 931/2011 on traceability requirements set by Regulation (EC) No 178/2002

French Consumer Code Art. L 214-1 al. 9 Mandatory mentions, information and traceability Idem Art. R. 112-2. reference identifying the lot of foodstuff Art. R214-4 on GMO pursuant to European directives

ISO 22 005: 2007 Traceability in the feed and food chain

RASFF7: The Rapid Alert System for Food and Feed.

Fishery products

Regulation1224/2009 Regulation 1379/2013 Articles 7 and 13

ISO 12875: 2011 Traceability of fishery products

7 http://ec.europa.eu/food/safety/rasff/index_en.htm

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References EU regulation French regulation

Related standards

EU alert system

Pharmaceutical products

Directive 2011/62 on the prevention of the entry into the legal supply chain of falsified medicinal products

French Public Health Code Ordnance no. 2012-1427of 19 December 2012 on reinforcing the security of the supply chain of medicines, restricting online sales of medicines and the combat against falsified medicines Decree no. 2012-1562of 31 December 2012 on reinforcing the security of the supply chain of medicines and supervising online sale of medicines

RAPEX

Toys Directive 2009/48 on the safety of toys

Ministerial Order of 18 December 2012 amending the ministerial order of 24 February 2010 laying down the procedures for implementing decree no. 2010-166 of 22 February 2010 on the safety of toys Ministerial Order of 31 July2013 amending the ministerial order of 24 February 2010 laying down the procedures for implementing decree no. 2010-166 of 22 February 2010 on the safety of toys

Cosmetic products

Regulation 1223/2009 on cosmetic products

French Public Health Code Articles L5134-1 to L5134-9

ISO 22716 (Cosmetics Good Manufacturing Practices)

RAPEX

Packaging Regulation1935/2004 on materials and articles intended to come into contact with foodstuff: art 17

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4. Implementing Traceability

4.1 Introduction

In this chapter, packaging is presented as a way to ensure traceability: the packaging must include an indication tracing the product it contains.

The CNE draws a non-comprehensive list of the means for implementing the traceability of the product/packaging pairing8.

Marking is one of the tools used to ensure traceability. It makes the identification of a product easier; when there are different trading partners along the industrial and logistics chain, markings must be functional (legible and usable by everyone). The information regarding traceability includes:

Legal notices If a single product is traced:

o Product identification number; o Unique serial number.

When tracing products with product batches: o Product identification number; o Lot number (logistics lot and production batch).

There are standards in all sectors, which translate into several types:

GS1 standards on product codification and marking, among which: o GTIN (Global Trade Item Number) to identify a product (consumer unit, logistic

unit) o SSCC (Serial Shipping Container Code) to identify a parcel

GS1 standards for identifying companies and locations: GLN (Global Location Number) for identifying the destination

Standards for identifying medicines: o CIP 13 code for medicines

Standards for identifying parts in the automotive industry: o The Galia code of the vehicle

In order to combat counterfeiting, security printing is a crucial economic lever for brands that need to trace their products because of counterfeit products that challenge them on their own markets.

4.2 The main marking technologies on paper and cardboard

4.2.1 Visible markers

This type of marking does not need to be revealed and aims mostly at enabling the consumer to identify the product and to deterring counterfeiting. Its authenticity can be verified by sight.

Besides anti-violation systems (markers that are directly affixed to the container, shrink films or labels), the following technologies can be applied to paper and cardboard:

serialisation: the identification of each product by an individual number

holographic image: the most common visible marking. It can be two or three dimensional, and is mostly used for luxury products, pharmaceutical products and alcohol, etc. It is based on the use of self-adhesive stickers that may contain elements enabling traceability.

8 Written with the help of CTP(The Pulp and Paper Research & Technical Centre) and GS1

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watermarks These processes are based on the intrinsic characteristics of the product, which are used as a mean of authentication. They guarantee the protection of brands, the traceability of industrial products, and the authentication and safety of digital data and images as well as that of printed documents.

Watermarks have become a symbol of safety, as they have been effective for years. A watermark is a pattern (portrait or emblem, etc.) affixed to the paper during manufacturing that is mostly visible when the paper is held up to the light. This pattern is incorporated into the paper paste during the manufacturing of the sheets. It is based on the variation of the thickness and density of the paper, which translates into differences in opacity. It can hardly be seen under reflected light, but is easily seen under transmitted light. Watermarks are probably the first elements based on optical variation that were invented. They date back to the 13th century and were used at the beginning to identify some paper formats, then some types of paper and eventually the paper mills themselves. Nowadays, watermarks are an identification tool that is strongly promoted by Interpol, as they are really hard to reproduce.

4.2.2 Coded or invisible markings

This type of marking requires the use of tools in order to be interpreted and even when they are affixed to an object, they do no concern the end user.

Barcodes

One-dimensional barcodes – They are affixed to the container and/or the packaging These were the first codes to be printed on packaging or tags in 1973. Bar codes are made of a code represented by numbers and a symbol represented by bars. European countries refer to theGS1 EAN (Gencod EAN in France) (European Article Numbering). This is an international barcode standard9 for coding and marking which covers several symbols, among which the most widely spread is EAN 13. The use of a barcode enables the manufacturer to identify each unit composing a lot from the manufacturing process to distribution. It makes it easier for distributors to manage their stocks, among other things. The use of barcodes is subjected to physical requirements such as the dimension and form of the support, the background colour, etc. This type of code must be associated with an optical reading device.

Two-dimensional barcodes These are two-dimensional barcodes (or matrix codes) made of black dots arranged on white squares. There are two protocols, which serve the same purpose: Datamatrix, notably used in the health sector in France. QR (Quick Response Code) often linked to a URL address. These two codes are intended to be read by two-dimensional readers such as mobile phones or smartphones. They can hold more information than linear codes.

9 For additional information, see GS1

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RFID tags– They are put on/in the product or packaging itself. This technology enables contactless product marking and reading. RFID (Radio Frequency Identification) consists in attaching an electronic tag to a product or its packaging or container. The electronic tag contains information that can be used to manage stocks and trace products and is read with a specific device. A RFID system is made of 3 elements: o The tag:

is made of an antenna to communicate with reading devices and a chip with a unique number and with or without additional memory,

is affixed to the element to be identified, can have different designs (card, pellet, token, capsule, adhesive stickers), it is either read-only (most common case):the data transferred by the

manufacturer cannot be modified or completed afterwards; or read-write: the user can add information or write over existing information contained in the tag from afar,

it is either active (with an internal power source) to power additional memory, a sensor… or passive: data transmission to the tag is based on a remote power supply.

o The reader enables communication with the tag, o The information system (IS) manages the functions and processes that either have

an impact on the data exchanged with the tag or use them, All these components guarantee:

the physical traceability of exchanges(frequency, data transfer rate, modulation, etc...),a piece of information that follows the unit along the different steps of the supply chain,

the logical management of exchanges, notably to enable upstream and downstream traceability (protocols),

the storage of data, which will guarantee better traceability for all the stakeholders.

Integrating it into the manufacturing of the packaging helps to reduce the cost of the tag, increases transparency and optimises its use, for example, the distance from which it can be read.10 It is important to note that chipless RFID systems are being designed (CTP11) to:

decrease tag cost (the cost of the chip represents around 2/3 of the final cost), increase data safety (read-only) improve recyclability (no chip, no glue, no copper antenna), increase reliability: unaffected by temperature or vibrations.

Microelectromechanical Systems Systems, the size of which can vary from a few microns to a few dozens of nanometres. o Impervious to autoclaving, gamma sterilization and humidification o Immune to electromagnetic waves To date, they are seldom used in the packaging industry

Cryptoglyph12 crypto = crypting, Glyph = marking The markings are made of numerous microdots, invisible to the naked eye and printed by the standard equipment belonging to the manufacturers/printers of secondary or primary packaging, among which paper and cardboard packaging: AlpVision is the only technology which enables the embedding of dots in the imperfections of the printed material.

10 Expérience industrielle du projet DECARTE (Industrial experiment lead by DECARTE Project) –The Pulp and Paper Research & Technical Centre 11 A. Vena, E. Perret, S. Tedjini, G. Eymin-Petot-Tourtollet, A. Delattre, F. Garet, Y. Boutant, “Design of Chipless RFID Tags Printed on Paper by Flexography,” IEEE Transactions on Antennas and Propagation,

vol. 61, no. 12, pp. 5868 - 5877, Dec. 20 12 Technology designed and patented by Swiss company AlpVision SA.

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4.2.3 Expert markings

This type of marking covers markings that require tools to be read and checked. Chemical marking is the most widespread technology. It is based on the introduction of molecules (artificial DNA, nanoparticles, etc.) into the chemical makeup of the material in order to be able to precisely identify it. This process is generally used in the automotive industry, polymers, electronics, domestic appliances and packaging made of paper or cardboard, for example.

This technology allows:

Traceability to integrated into the material Easier identification of materials environmentally-friendly product design from the manufacturing process onwards in order

to manage the last step of their lifecycle (sorting, recycling or recovering secondary raw materials)

traceability of materials and products at each step of their lifecycle.

4.3 Printing techniques

Security markings are part of the printing process: invisible inks, UV, infrared, microspheres and artificial DNA. They have been adapted to the different printing techniques. The fact that there are different processes makes it easier to combine different security markings, when needed. For instance, invisible inks printed with inkjet digital presses will make it possible to personalize the lots. However, the size of the drops in the Piezo inkjet printing technique does not make it possible to emboss micro particles. These are then printed using screen-printing, heliography or flexography. The security printing market adapts to the brands’ demands, which can vary depending on the sector.

Microprinting– Microtag Microtags are a microscopic technology that aims at countering counterfeiting and increasing traceability. This technology is based on the piling of numerous coloured layers that form a digital code.

Printing with colour-changing thermochromic or photochromic inks Thermochromic or photochromic inks are based on metal pigments whose colours vary in response to heat and/or light variation. As of now, this type of marking is mostly used to print money. There are different types of inks used such as UV, infrared, magnetic and optical variable inks. Phosphorescent inks are either organic pigments that do not last long (Organophosphorus compounds) or mineral pigments that last longer, but are less effective (zinc sulphates, cadmium, strontium, calcium, etc.). They are used, for example, in the photoluminescent threads used to bind passports or in the fibers incorporated beforehand in the paper paste used to produce fiduciary documents.

Thermal inkjet coding on secondary packaging A compact printing block with ink cartridges that enables automatic inkjet coding on the fly on packaging in order to code cardboard packaging (lot, product code, barcodes).

Digital printing Digital technology has made it possible to apply reliable techniques that were previously only used for printing in the fiduciary business to product packaging, especially to protect documents against counterfeiting.

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5. Traceability and the Environment

5.1 Introduction

The means/markings described in chapter 4 are used to guarantee traceability. Their usage must be part of an environmentally-friendly approach to design that takes into consideration the recyclability of the packaging. Recycling aims at collecting the material forming the packaging in order to reuse it later on. Recyclability implies not only that the packaging can be sorted, but also that the material composing the packaging can be easily collected.

5.2. Ground rules for optimising recyclability

To ensure that the packaging can still be recycled, the marking process must follow certain ground rules, among which the following three are essential:

5.2.1. Reduce the association of “contaminating” elements and matter to the main material in the packaging

In theory, trackers affixed to the packaging should not make it more “complex”, for fear that recyclability be reduced. This is why watermarks, which mark the surface of the paper/cardboard by pressure without inking or adding other materials, represent a tracing method that has no impact on the recycling process of the packaging. Conversely, other trackers require materials differing from the packaging itself, which can restrict or hinder some recycling processes. For instance, the use of metals can potentially have a heavy impact on sorting and recycling, most notably in the following instances:

when it comes to glass packaging management because of disturbances induced in glass furnaces: the introduction of ‘contaminating elements’ (be they organic or metallic, etc.) in the furnaces causes the final cullet to change colour;

the PET recycling industry: metal, whatever its shape, disturbs the PET recycling process, because it has an impact at different steps of the process:

o during the sorting process: optical sorters detect metals that cause disturbance in the recycling process. As a consequence, the packaging containing metal is removed;

o during the recycling process itself: as their density is often higher than 1, metal particles cannot be separated using the PET flotation process, as PET has a density higher than 1. They are consequently collected with PET for recycling.

5.2.2. Encouraging the separation and elimination of the tracer

The removal of the marking depends on:

the ink type, the quantity used and the degree to which it can be eliminated, especially when the packaging is directly printed upon and then becomes the tracer itself. These parameters, which determine the choice of tracer, can have an impact on:

- the quality of recyclables Some inks, notably the UV inks used in thermochromic and photochromic markers, require ink adhesion treatment to improve the ink adhesion to the support. When it comes to recycling paper/cardboard, this means that de-inking the fibres can sometimes be necessary, depending on the chosen output, and implies the total suppression of the ink in the fibres, which is difficult to achieve with this type of ink.

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The recycling processes of plastic packaging waste tend generally to be based on the use of washable ink to eliminate any trace of adjuvants in the recycled flakes. The pigment type, its colour and the use of overcoats or adhesive products are criteria that need to be taken into account to optimise recycling quality;

- protecting the integrity of recycling equipment Being hydrosoluble, some adjuvants can, in some cases, pollute the recycling circuit and especially wash water. To optimise packaging recyclability, the quantity of adjuvants must be reduced as well as the use of bright colours, which wash out a lot and may taint the process water. The two types of markings – barcodes and QR codes– cause no such phenomenon, as less ink is used and only two colours– black and white– are used.

The type of glue and its level of adhesiveness when the tracer is directly affixed onto the packaging via a tag, a chip, etc. For instance, holograms on self-adhesive stickers are often highly adhesive.

5.2.3. Abiding by health legislation (heavy metals, food contact compliance, etc.)

Packaging is only recyclable when the waste recovery process that it undergoes leads to the integration of the material of which it is made into a new product. Marketed products containing recycled matter must not present health hazards. This is why regulation is strict regarding a number of substances such as heavy metals, bisphenol A, etc. Such risk may only be completely eliminated if the recyclable does not contain substances that are potentially harmful or toxic to human health.

5.3 Tools and guidelines To fulfil these objectives, tools have been designed and made available to professionals working in packaging manufacturing and conditioning who want guidance as to the choice of materials. Some of the tools are:

The TREE software (Packaging recyclability test): http://tree.ecoemballages.fr designed by Eco-Emballages. It makes it possible to assess the recyclability of domestic packaging and offers alternatives regarding design if a disturbance is identified in the recycling process.

The guidebook published by Revipac and Eco-Emballages on the ‘Recyclage et la recyclabilité des emballages ménagers papier-carton usagés’ (Recycling and recyclability of used paper/cardboard domestic packaging)

Two expert committees are also working to improve domestic packaging recyclability by explaining to companies the degree to which their packaging can be recycled and sharing their technical knowledge, by way of best practice guidelines.

Le Comité Technique pour le Recyclage des Emballages Plastiques (COTREP) (Technical Committee for Plastic Packaging Recycling): http://www.cotrep.fr

Le Comité d’Evaluation de la Recyclabilité de Emballages papier-Carton (CEREC) (Review Committee for Paper-Cardboard Packaging Recycling): http://www.cerec-emballages.fr

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6.1 Packaging Traceability This sub-chapter focuses on packaging traceability. It traces information regarding the packaging itself (origin of the material, packaging life cycle, etc.). The examples below, although far from complete, allow stakeholders to: - identify the origin of the raw materials used in the packaging, - trace the life of the packaging itself, - manage packaging stocks and flows.

6.1.1 Origin of Wood Used to Make Oak Barrels in Viticulture 13 Oak barrels in viticulture are an example of packaging. Many viticulturists use oak barrels to turn grapes into wine. They want to be able to determine the origin of the oak with certainty. Therefore, in order to meet the need for to be able to trace the material used to make this oak packaging, INRA Bordeaux-Aquitaine has developed two genetic marker kits that can identify the origin and species of the oak. Coopers will thus be able to verify and certify the conformity of the batch of oak used to make their barrels. The Technical Institute FCBA (Forestry, Cellulose, Construction Timber and Furniture) is responsible for transferring this technology to coopers and other stakeholders in the industry.

6.1.2 Reusable Cardboard Pallet Management by DS SMITH14

OTC-KAYPAL®15 MR concentrates its research and development projects on innovative ideas. The “service” component associated with this packaging is the Open Tracing Container function. The goal is to establish a unitary traceability model for this packaging. The following questions regarding the life cycles of these cardboard pallets should be answered:

Where are the pallets broken or lost? Where are they best handled? Where do they function quickly or more slowly? Where are they available for collection? Where is the sleeping stock? How often are they used and how long is their operating life? Where do they disappear? What is their storage time at each site?

The implemented solution is multi-partner:

Implementing Electronic Product Code (EPC) standards in an open loop. Moving information capture and transmission in “quasi-real time” to strategic points of

the supply chain using adapted RFID technology. Storing captured information in EPCIS traceability databases. Developing “Professional Web Service” applications based on standards as a real

support to an innovative business model.

13 Réussir Vigne – Novembre 2014 14 Source : DS SMITH et GS1 15 Open Tracing Container

6. Some Examples of Traceability

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Aims: Significantly improve the traceability of flows of reusable containers and their contents in an

open loop.

Act to limit the environmental footprint of goods transport through optimisation and improved performance.

Facilitate decision-making concerning investments in new generation reusable containers by proving their reliability (management, traceability, standards, web services, etc.).

Encourage the development of new business models in order to advance the mutualisation of logistic and transport resources and the development of multi-support solutions in a competitive and interoperable multi-stakeholder framework.

Thus, packaging itself can be traced in order to improve economic and environmental efficiency, at the same time as creating value. It is possible to follow the logistic route and the life cycle of the packaging, which allows planning of its value chain: manufacture, transportation, storage, repair, re-use, etc.

6.1.3 Packaging in contact with foodstuff Packaging that is intended to come into contact with foodstuff is governed by European Regulation no. 1935/2004 that aims “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 foodstuff, whilst providing the basis for securing a high level of protection of human health and the interests of consumers.”

This Regulation introduces in article 17 a traceability requirement for materials and articles that are intended to come into contact with foodstuff, namely:

1. The traceability of materials and articles shall be ensured at all stages in order to facilitate control, the recall of defective products, consumer information and the attribution of responsibility. 2. With due regard to technological feasibility, business operators shall have in place systems and procedures to allow identification of the businesses from which and to which materials or articles and, where appropriate, substances or products covered by this Regulation and its implementing measures used in their manufacture are supplied. That information shall be made available to the competent authorities on demand. 3. The materials and articles which are placed on the market in the Community shall be identifiable by an appropriate system which allows their traceability by means of labelling or relevant documentation or information.

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6.2 Product Traceability by the packaging In this sub-chapter, packaging provides information about its contents. The examples below are not complete, but they illustrate the field of possibilities for tracing the life of a product.

6.2.1 All Products

Material finger printing 16: a means of securing traceability data. It would be highly unlikely to find nowadays a product on which no date of production, batch number or some sort of bar code would appear. Alphanumeric codes, data matrix or even a two-out-of-five code - there are numerous ways to incorporate all sorts of information, either thanks to size or through connection to a database. The product and its indications therefore need to be printed on the production line or the packaging line, and then read before dispatch and again in the distribution channel, before the product is sold. There could also possibly be a link with the client, the final consumer. This code will therefore be vital for reasons of public health, warranty and customer care. If the code ever disappears or is falsified or reproduced on any products, traceability stops. Consequently, it is indispensable to protect traceability data and, where possible, to capture it in unitary authenticators. This concept will allow data to be secured, but also conserved, in the event that it disappears. The principle is simple and recent. It is similar to digital fingerprinting, except that there is the question of primary or secondary packaging and their products. Thus, the material fingerprint of a product and/or its packaging must be taken and paired with its clear identifier. Process:

A simple vision system, in other words a camera, is needed in the production, printing or packaging line. This camera, that can detect predetermined areas when a product to be registered passes in front of its field, immediately processes the detected markers in random alphanumeric codes that will be saved in a database. Beforehand, a code printed on a product (its identifier) will be read by the same system and will be paired with what is known as the material code. The visible data and the invisible data generated by the system become one. The unitary authenticator is thus created and saved in the database. The significant advantage is that it cannot be falsified, deleted, copied, imitated or re-produced, as it is immaterial. Traceability is thus protected and, except in the event of the destruction of the product or its packaging, the code can be read anonymously, without the person overseeing the proofreading having any knowledge of the location of the code. When the material code is read, all of the paired data will be revealed. For a case or a cardboard box, for example, material fingerprinting can be done at the printer or directly at the business that has put in place the system (the cases are thus delivered by the printer and re-dispatched after coding at the industrial user). These options depend on the required level of confidentiality. In fact, manufactures now have the possibility of an immaterial system, without consumables or zone identification. They can thus choose a completely secret process.

16 Concept Signoptic: Source Arjowiggins security

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Advantages of material fingerprinting: • It is impossible to falsify, imitate or re-produce the code: the signature is completely unique

and can only be located by means of the registered product. • The coding is invisible, since it does not materially exist: the protection cannot be questioned;

nothing is added to the product. • Authentication cannot be doubted. There is no human interpretation. • Its resistance to fraud is incomparable. Even in the case of identification zones, it is necessary

to damage the product to the extent that it can no longer be sold. • In the event that printed visible codes disappear, all information can be found thanks to

technology. • The code is very light: 1 million codes = 1GB. • All sorts of computer data can be paired. • Independent readers that are connected to Wi-Fi or 3G and have geolocation and timestamp

controls are available. They can also contain the database. • A simple add-on can also be added to a smartphone onto which the application has been

downloaded.

6.2.2 Food Products

Foodstuff is governed, among others, by Regulation no. 178/2002 that determines the general principles of food legislation and notably a general traceability requirement (article 18). In fact, in recital 28, the Regulation states, “it is […] necessary to establish a comprehensive system of traceability within food and feed businesses so that targeted and accurate withdrawals can be undertaken or information given to consumers or control officials, thereby avoiding the potential for unnecessary wider disruption in the event of food safety problems.”

Amongst the obligations set out by article 18 of this Regulation is the obligation to implement labelling or identification procedures for commercialised products to allow and facilitate traceability. Directive 2011/91 clarifies the identification conditions for batch numbers, stating that the batch number has to appear on the pre-packaging or on a label attached thereto in the case of pre-packaged food products. The indication has to be easily visible, clearly legible and indelible. Thus, pre-packaged foodstuff is identified by a batch number. The latter is indispensable for traceability, and the packaging is therefore a source of information. Packaging does not only convey traceability in the strictest sense. It also provides other information required by European regulation (particularly Regulation (EU) no. 1169/2011). The packaging gives information in relation to traceability, such as the name or registered name and the address of the person liable.

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6.2.3 Cosmetic Products17 Cosmetic products in particular are governed by cosmetic Regulation no. 1223/2009/EC18 . The following recommendations can be found in the preamble to this Regulation: (4) This Regulation comprehensively harmonises the rules in the Community in order to achieve an internal market for cosmetic products while ensuring a high level of protec¬tion of human health. (12) Ensuring traceability of a cosmetic product throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates market surveillance authorities’ task of tracing economic operators. In article 19 of this Regulation, packaging19 is clearly identified as a means of information in relation to traceability. For example: • Name or registered name and address of the person liable • Country of origin of cosmetic products imported into the EU • Date of minimum durability • Information concerning particular precautions to be observed in use (for example, a warning on toothpaste: “contains sodium fluoride”) • The manufacturing batch number or the reference number identifying the cosmetic product. It can guarantee identification of a batch of cosmetic products throughout the supply chain, particularly in the case of a recall. • A list of ingredients (INCI) The Fédération des Entreprises de la Beauté (FEBEA)20 has published a "best practices" guide for labelling. The required information must appear on the labels of the container and packaging of every cosmetic product. The list of ingredients may only appear on the packaging. FEBEA, ECR France and GS1 France have moreover published a “Logistics Best Practices Guide 21for Commercial Shipments to Warehouses” that confirms that packaging constitutes an integral part of the logistic flow of cosmetic products and carries information that makes the supply chain more fluid and facilitates any possible recalls. Moreover, packaging is a tool with which to combat counterfeiting thanks to the following measures: • Printing a unique code (fingerprint) on each product: if the same barcode appears twice or more, the products are counterfeits; • Printing a manufacturing number on all of the products: printing the date of manufacture in letters and numbers on the case and the primary container.

17 Source: Fédération des entreprises de la beauté (FEBEA) 18 Regulation no. 1223/2009/EC of the European Parliament and of the Council of 30 November 2009 on

cosmetic products 19

Two types of packaging:

The container (also referred to as the primary packaging or the interior packaging) is the

packaging that is intended to come into contact with the product;

The packaging (also referred to as the secondary packaging or the exterior packaging) is the

packaging that is intended to contain one or more containers, including protective materials, where appropriate.

20 A Practical Guide to Cosmetic Product Labelling – Compliancy with Cosmetics Regulation (October 2012). Available (French only):www.febea.fr 21 http://www.publications.gs1.fr/Publications/Parfumerie-Selective-bonnes-pratiques-des-flux-marchands-

sur-entrepots

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6.2.4 Pharmaceutical Products22 The packaging of pharmaceutical products is a guarantee of the quality, traceability and safety, security (one of the performance criteria of European Standard EN 13428) as well as of the integrity of its contents. The packaging does not only include the packaging of the pharmaceutical form that is in immediate contact with the medicine (primary packaging), but also the exterior packaging (secondary packaging) that contains the bottle, sachet, tube or (blister) pack where the product, its instructions and possibly its administration device are found. It should be made clear here that packaging, just like the results of clinical studies, toxicology and pharmacology studies and manufacturing and control processes studies, is part of the marketing authorisation application dossier (AMM) that is submitted to the health authorities. It is key to guaranteeing the authenticity and traceability of the medicine. The following obligatory indications must appear on the packaging:

• Name (INN23 + brand name or name of marketing authorisation holder) • Dose (composition of the active ingredients per dosage unit) • Pharmaceutical form • Method of administration • Batch number • Expiry date • Special storage precautions.

Moreover, falsifying drugs can lead to serious consequences for the health of anyone who is misled. It should be recalled that drug fraud has accompanied the growth of Internet shopping: according to the WHO24 , almost 50% of falsified medicines are bought on the Internet. Counterfeiting can affect both brand and generic drugs. The legal pharmaceutical supply and distribution channel particularly limits the risk of falsification in France. Directive25 2011/62/EU defines falsified medicine as medicine that falsely represents:

• Its identity, including its packaging and labelling, its name or its composition as regards to any of its ingredients, including excipients and the strength of those ingredients,

• Its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder,

• Its history, including records and documents relating to the distribution channels used.

It provides for the implementation of new provisions for securing the medicine supply chain and packaging in order to make it more difficult to introduce falsified drugs into the legal medicine channel, as well as much easier to detect any such introduction.

22 Source: French Pharmaceutical Industry Association (LEEM) 23 International Non-proprietary Name of principal ingredient 24 Bulletin of the World Health Organisation, “Growing threat from counterfeit medicines”, volume 88,

number 4, April 2010, 241-320. Available: http://www.who.int/bulletin/volumes/88/4/10-020410/en/ 25 Directive 2011/65/EU of the European Parliament and the European Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the

prevention of the entry into the legal supply chain of falsified medicinal products.

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Packaging is thus the first support for pharmaceutical products traceability, and contributes to patient trust:

• It carries important information for the patient concerning storage and usage of the product.

• It helps combat falsification while generalising the integration of safety systems (holograms, inviolability systems, indicators for cutting, etc.).

• From 2018 onwards, it will guarantee that the fight against falsification is more effective, as the exterior packaging of medicines will be required to carry serialised 2D codes (in accordance with the above Regulation).

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6.2.5 Wine Products Wine with a unique code carried by the packaging (security chip) For example, the Bordeaux Wines Council (CIVB)26 wants to guarantee throughout the logistic chain that the product in the bottle conforms to the expectations of the consumer. The packaging bottle is the means of traceability currently being investigated by the CIVB and its partners. Challenges: In the face of growing counterfeiting, particularly in Asia, the CIVB wants to protect all 65 appellations of Bordeaux wine by affixing an obligatory guarantee seal to the 700 million bottles that are produced every year. “It is therefore necessary to add new means of authentication to the containers of Bordeaux wines and particularly to bottles. These means have to be a real guarantee in the face of counterfeiting, which is particularly high in some markets. The deployment of an insufficiently effective solution would be dramatic. The consumer would associate an authenticator that is supposed to be reliable, but is actually false, with a substandard or fake wine that they believe to be authentic.” 27 Obligation to protect: The CIVB’s notes indicate how the system would be managed: “All containers of Bordeaux Wine that are put on the market will have to carry a seal of guarantee, subject to current tender offers. […] Economic criteria will influence the choice of supplier, although they should not be detrimental to the quality of the solution, the objective of which will be to guarantee strong authentication.” Thus, these are the principal technical solutions that should be implemented for real secure traceability of bottles. European legislation has intended them for a long time. General outline of the solution: “A unique and random serial number (identifier), created by the CIVB, is associated with each bottle. This code is carried by a seal of guarantee on which appears authenticating elements that can be verified by the consumer, players in the supply chain or control authorities according what they are authorised to do, what they know how to do and what the necessary tools are. […] The solution will have to allow the identification, authentication and traceability of all Bordeaux wine bottles” […].

26 Bordeaux Wines Council (Comité interprofessionnel des vins de Bordeaux) 27 Source: “Contre-façon Riposte” website, Philippe Collier on Jean Belaube, administrative director of the

Bordeaux Wines Council, October 2014

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7.1 Definitions Definition of Packaging Packaging28 is defined as any product made of any materials of any nature for the containment, protection, handling and delivery of goods, from the producer to the consumer or user. “Non-returnable” items used for the same purposes should also be considered to constitute packaging. Packaging29 consists only of: 1° Sales packaging or primary packaging (I), i.e. packaging conceived so as to constitute a sales unit for the final user or consumer at the point of purchase; 2° Grouped packaging or secondary packaging (II), i.e. packaging conceived so as to constitute at the point of purchase a grouping of a certain number of sales units, whether the latter is sold as such to the final user or consumer or whether it serves only as a means to replenish the displays at the point of sale. It can be removed from the product that it contains or protects without affecting its characteristics; 3° Transport packaging or tertiary packaging (III), i.e. packaging conceived so as to facilitate handling and transportation of a number of sales units or grouped packaging in order to prevent physical handling and transport damage. Transport packaging does not include road, rail, river, sea or air containers.

7.2 Main regulatory texts (to learn more)

European regulation 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 “Article 1: Aim and scope 1. This Regulation provides the basis for the assurance of a high level of protection of human health and consumers' interest in relation to food, taking into account in particular the diversity in the supply of food including traditional products, whilst ensuring the effective functioning of the internal market. It establishes common principles and responsibilities, the means to provide a strong science base, efficient organisational arrangements and procedures to underpin decision-making in matters of food and feed safety. 2. […] this Regulation lays down the general principles governing food and feed in general, and food and feed safety in particular, at Community and national level. It establishes the European Food Safety Authority. It lays down procedures for matters with a direct or indirect impact on food and feed safety.

28 Environmental Code (Book V, Title IV, Chapter III, section 5, Article R543-43) 29 Directive no. 94/62/EC on packaging and packaging waste

7. Appendices

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3. This Regulation shall apply to all stages of production, processing and distribution of food and feed. It shall not apply to primary production for private domestic use or to the domestic preparation, handling or storage of food for private domestic consumption.” It is therefore necessary to establish a comprehensive system of traceability within food and feed businesses so that targeted and accurate withdrawals can be undertaken or information given to consumers or control officials, thereby avoiding the potential for unnecessary wider disruption in the event of food safety problems. It is necessary to ensure that a food or feed business including an importer can identify at least the business from which the food, feed, animal or substance that may be incorporated into a food or feed has been supplied, to ensure that on investigation, traceability can be assured at all stages. “Article 13: International standards Without prejudice to their rights and obligations, the Community and the Member States shall: (a) contribute to the development of international technical standards for food and feed and sanitary and phytosanitary standards; (b) promote the coordination of work on food and feed standards undertaken by international governmental and nongovernmental organisations; (c) contribute, where relevant and appropriate, to the development of agreements on recognition of the equivalence of specific food and feed-related measures; (d) give particular attention to the special development, financial and trade needs of developing countries, with a view to ensuring that international standards do not create unnecessary obstacles to exports from developing countries; (e) promote consistency between international technical standards and food law while ensuring that the high level of protection adopted in the Community is not reduced.” “Article 14: Food safety requirements 1. Food shall not be placed on the market if it is unsafe […] 6. Where any food which is unsafe is part of a batch, lot or consignment of food of the same class or description, it shall be presumed that all the food in that batch, lot or consignment is also unsafe, unless following a detailed assessment there is no evidence that the rest of the batch, lot or consignment is unsafe. » “Article 17: Responsibilities Food and feed business operators at all stages of production, processing and distribution within the businesses under their control shall ensure that foods or feeds satisfy the requirements of food law which are relevant to their activities and shall verify that such requirements are met”.[…]

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“Article 18: Traceability 1. The traceability of food, feed, food-producing animals, and any other substance intended to be, or expected to be, incorporated into a food or feed shall be established at all stages of production, processing and distribution. 2. Food and feed business operators shall be able to identify any person from whom they have been supplied with a food, a feed, a food-producing animal, or any substance intended to be, or expected to be, incorporated into a food or feed. To this end, such operators shall have in place systems and procedures which allow for this information to be made available to the competent authorities on demand. 3. Food and feed business operators shall have in place systems and procedures to identify the other businesses to which their products have been supplied. This information shall be made available to the competent authorities on demand. 4. Food or feed which is placed on the market or is likely to be placed on the market in the Community shall be adequately labelled or identified to facilitate its traceability, through relevant documentation or information in accordance with the relevant requirements of more specific provisions”. […] “Article 19: Responsibilities for food: food business operators 1. If a food business operator considers or has reason to believe that a food which it has imported, produced, processed, manufactured or distributed is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food in question from the market where the food has left the immediate control of that initial food business operator and inform the competent authorities thereof. Where the product may have reached the consumer, the operator shall effectively and accurately inform the consumers of the reason for its withdrawal, and if necessary, recall from consumers products already supplied to them when other measures are not sufficient to achieve a high level of health protection. 2. A food business operator responsible for retail or distribution activities which do not affect the packaging, labelling, safety or integrity of the food shall, within the limits of its respective activities, initiate procedures to withdraw from the market products not in compliance with the food-safety requirements and shall participate in contributing to the safety of the food by passing on relevant information necessary to trace a food, cooperating in the action taken by producers, processors, manufacturers and/or the competent authorities. 3. A food business operator shall immediately inform the competent authorities if it considers or has reason to believe that a food which it has placed on the market may be injurious to human health. Operators shall inform the competent authorities of the action taken to prevent risks to the final consumer and shall not prevent or discourage any person from cooperating, in accordance with national law and legal practice, with the competent authorities, where this may prevent, reduce or eliminate a risk arising from a food. 4. Food business operators shall collaborate with the competent authorities on action taken to avoid or reduce risks posed by a food which they supply or have supplied.”

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DIRECTIVE 2001/95/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 3 December 2001 on general product safety Scope: It is […] necessary to establish at Community level a general safety requirement for any product placed on the market, or otherwise supplied or made available to consumers, intended for consumers, or likely to be used by consumers under reasonably foreseeable conditions even if not intended for them. In all these cases the products under consideration can pose risks for the health and safety of consumers which must be prevented. “Article 3 : Producers shall be obliged to place only safe products on the market.” […] Article 5 : 1. […] Within the limits of their respective activities, producers shall provide consumers with the relevant information to enable them to assess the risks inherent in a product throughout the normal or reasonably foreseeable period of its use, where such risks are not immediately obvious without adequate warnings, and to take precautions against those risks. The presence of warnings does not exempt any person from compliance with the other requirements laid down in this Directive. Within the limits of their respective activities, producers shall adopt measures commensurate with the characteristics of the products which they supply, enabling them to: a) be informed of risks which these products might pose; b) choose to take appropriate action including, if necessary to avoid these risks, withdrawal from the market, adequately and effectively warning consumers or recall from consumers. The measures referred to in the third subparagraph shall include, for example: a) an indication, by means of the product or its packaging, of the identity and details of the producer and the product reference or, where applicable, the batch of products to which it belongs, except where not to give such indication is justified and b) in all cases where appropriate, the carrying out of sample testing of marketed products, investigating and, if necessary, keeping a register of complaints and keeping distributors informed of such monitoring.[…] 2. Distributors shall be required to act with due care to help to ensure compliance with the applicable safety requirements, in particular by not supplying products which they know or should have presumed, on the basis of the information in their possession and as professionals, do not comply with those requirements. Moreover, within the limits of their respective activities, they shall participate in monitoring the safety of products placed on the market, especially by passing on information on product risks, keeping and providing the documentation necessary for tracing the origin of products, and cooperating in the action taken by producers and competent authorities to avoid the risks. Within the limits of their respective activities they shall take measures enabling them to cooperate efficiently. 3. Where producers and distributors know or ought to know, on the basis of the information in their possession and as professionals, that a product that they have placed on the market poses risks to the consumer that are incompatible with the general safety requirement, they shall immediately inform the competent authorities of the Member States […], giving details, in particular, of action taken to prevent risk to the consumer. The Commission shall, in accordance with the procedure referred to in Article 15(3), adapt the specific requirements relating to the obligation to provide information laid down in Annex I. 4. Producers and distributors shall, within the limits of their respective activities, cooperate with the competent authorities, at the request of the latter, on action taken to avoid the risks posed by products which they supply or have supplied. The procedures for such cooperation, including procedures for dialogue with the producers and distributors concerned on issues related to product safety, shall be established by the competent authorities.

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Article 8 1. […] the competent authorities of the Member States shall be entitled to take, inter alia, the measures in (a) and in (b) to (f) below, where appropriate: a) for any product: i) to organise, even after its being placed on the market as being safe, appropriate checks on its safety properties, on an adequate scale, up to the final stage of use or consumption; ii) to require all necessary information from the parties concerned; iii) to take samples of products and subject them to safety checks; b) for any product that could pose risks in certain conditions: i) to require that it be marked with suitable, clearly worded and easily comprehensible warnings, in the official languages of the Member State in which the product is marketed, on the risks it may present; ii) to make its marketing subject to prior conditions so as to make it safe; c) for any product that could pose risks for certain persons: to order that they be given warning of the risk in good time and in an appropriate form, including the publication of special warnings; d) for any product that could be dangerous: for the period needed for the various safety evaluations, checks and controls, temporarily to ban its supply, the offer to supply it or its display; e) for any dangerous product: to ban its marketing and introduce the accompanying measures required to ensure the ban is complied with; f) for any dangerous product already on the market: i) to order or organise its actual and immediate withdrawal, and alert consumers to the risks it presents; ii) to order or coordinate or, if appropriate, to organize together with producers and distributors its recall from consumers and its destruction in suitable conditions. 2. When the competent authorities of the Member States take measures…, they shall act in accordance… in such a way as to implement the measures in a manner proportional to the seriousness of the risk, and taking due account of the precautionary principle. In this context, they shall encourage and promote voluntary action by producers and distributors, in accordance with the obligations incumbent on them under this Directive… including where applicable by the development of codes of good practice. If necessary, they shall organise or order the measures provided […] if the action undertaken by the producers and distributors in fulfilment of their obligations is unsatisfactory or insufficient. Recall shall take place as a last resort. It may be effected within the framework of codes of good practice on the matter in the Member State concerned, where such codes exist. 3. In particular, the competent authorities shall have the power to take the necessary action to apply with due dispatch appropriate measures… in the case of products posing a serious risk. These circumstances shall be determined by the Member States… 4. The measures to be taken by the competent authorities under this Article shall be addressed, as appropriate, to: a) the producer; b) within the limits of their respective activities, distributors and in particular the party responsible for the first stage of distribution on the national market; c) any other person, where necessary, with a view to cooperation in action taken to avoid risks arising from a product.

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Consumer Code in France

Article L.214-1 al. 9 Article R.112-7. The labels and labelling methods used must not be such as to give rise to confusion in the mind of the purchaser or the consumer, particularly as to the characteristics of the foodstuff and, specifically, as to its nature, identity, properties, composition, quantity, durability, method of conservation, origin or provenance, method of manufacture or production […]. Article R.112-9. Without prejudice to the provisions relative to metrological control, the labelling of pre-packaged food products, under the conditions and subject to the derogations provided by this chapter, shall include the following compulsory mentions: 1. The trade name; 2. A list of ingredients; 3. The quantity of certain ingredients or categories of ingredients, as specified in articles R. 112-117 and R. 112-117-1; 4. The net quantity; 5. The date of minimum durability or, in the case of foodstuff which is microbiologically perishable, the use-by date, as well as an indication of the special conditions of preservation; 6. The name or company name and address of the manufacturer or the packer or a supplier established within the European Community; 7. The batch number; 8. The place of origin or source, whenever the omission of such information is likely to create confusion in the mind of the buyer concerning the real origin or source of the foodstuff; 9. The instructions for use, whenever they are necessary for appropriate use of the foodstuff and, where applicable, the special conditions for use. Essential Requirements – Article R. 543-44 of the Environmental Code

Packaging referred to in article R. 543-42 has to meet the essential requirements defined below: 1° Requirements specific to the manufacturing and composition of packaging: a) Packaging shall be designed and manufactured so as to limit its volume and mass to the minimum required to maintain the necessary level of safety, hygiene and acceptance. b) Packaging shall be designed, produced and commercialised so as to permit its re-use or recovery, including its preparation for re-use or recycling, and to minimise its impact on the environment when packaging waste or residues from packaging waste management operations are disposed of. c) Packaging shall be manufactured so as to minimise the presence of noxious and other hazardous substances and materials in the packaging material with regard to emissions, ash or leachate that result from the incineration or storage of packaging or from waste management operations. 2° Requirements specific to the re-usable or recoverable nature of packaging: a) Re-usable packaging must simultaneously meet the following requirements: -the physical properties and characteristics of the packaging shall enable a number of trips or rotations in normally predictable conditions of use; -it must be possible to process the used packaging for new use without contravening existing health and safety requirements for the workforce; -the requirements specific to recoverable packaging when the packaging is no longer re-used and thus becomes waste must be met. b) Recoverable packaging shall be designed and manufactured so as to enable at least one of the following forms of recovery:

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-Preparation for re-use: it must be possible to process waste packaging for new use without contravening existing health and safety requirements for the workforce; -Material recycling: It must be possible to recycle a certain percentage by weight of the used materials into the manufacture of marketable products, in compliance with current standards in the European Community. This percentage can vary, depending on the type of material of which the packaging is composed. - Energy recovery: Packaging waste processed for the purpose of energy recovery shall have a minimum inferior calorific value to allow optimisation of energy recovery. - Composting: It must be possible to process the biodegradable nature of packaging for the purpose of composting without hindering separate collection or the composting process or activity into which it is introduced. - Biodegradable packaging: Biodegradable packaging waste shall be of such a nature that it is capable of undergoing physical, chemical, thermal or biological decomposition such that most of the finished compost ultimately decomposes into carbon dioxide, biomass and water.

7.3 Bibliography

‘Enquête: Traçabilité alimentaire: en toute transparence?’, Points de vente, no. 1132, March 2013. (Survey: Food Products Traceability: Is It Transparent?’)

‘Quand la Chine s'empoisonnera’, Courrier international, November 2011.(‘When China

Poisons Itself’) ‘La traçabilité, Quelles limites?’, Bulletin de l'ILEC, October 2010.(Traceability: Are There

Limits?’) ‘Sécurité: un consommateur sous haute protection’, Emballages Magazine, May

2010.(‘Safety: Consumers Under High Protection’) ‘Traçabilité, guide pratique pour l’agriculture et l’industrie alimentaire’, ACTIA, 2007.

('Traceability, a Practical Guide for Agriculture and the Food Industry’) ‘Sécurité consommateur: Qualité, traçabilité, gestion de crise’, ECR, April 2004.(‘Consumer

Safety: Quality, Traceability and Crisis Management’) French Consumer Code and French Public Health Code http://tree.ecoemballages.fr

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French Packaging Council – All Rights Reserved – March 2015 31

With thanks to members of the working group and contributors

LAWYER AT THE COURT OF APPEAL OF PARIS E. BON LAWYER AT THE COURT OF APPEAL OF PARIS S. MARTIN ARJOWIGGINS SECURITY H. CARN CARREFOUR B. GARNIER CARTON ONDULE DE FRANCE K. DESBOUIS CENTRE TECHNIQUE DU PAPIER D. OTTENIO CLUB BIOPLASTIQUES F. NYS CNE M. BRICOUT CNE M. FONTAINE CNE B. SIRI DSSMITH G. MATHIEU DSSMITH N. LE LAY DSSMITH M. BULTELLE ECO-EMBALLAGES M. PAILLEUX FEBEA N. DELANGLE FEBEA V. D’ENFERT FEDERATION DE LA PLASTURGIE ET DES COMPOSITES M. MADEC FROMAGERIES BEL P. BRAUN FROMAGERIES BEL K. CZYZOWICZ GS1 S. CREN GS1 (doctoral student at the AgroParisTech Foundation) G. PETIT LEEM D. CAROFF LEEM A. CARPENTIER LEEM C. MARECHAL L'OCCITANE P. DE BRUGIERE SYSTEME U J.M. POINTET

All of our publications are available on our website: www.conseil-emballage.org

For more information, please contact:

Bruno Siri, General Manager, or Maryse Bricout The French Packaging Council

Telephone: +33 (0)1 53 64 80 30 E-mail: [email protected]

8. Acknowledgements

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French Packaging Council – All Rights Reserved – March 2015 32

Board of Directors

Michel Fontaine, President

Georges Robin, Honorary President Noel Mangin, REVIPAC, Treasurer

Evangeline Baeyens, ILEC Jacques Bordat, CSVMF

Eric Brac de la Perriere, ECO-EMBALLAGES François Carlier, CLCV Jacques Creyssel, FCD

Olivier Draullette, CLIFE Françoise Gérardi, ELIPSO

Philippe Joguet, FCD Guy Lagonotte, Familles de France Jan Le Moux, ECO-EMBALLAGES

Arnaud Rolland, COCA-COLA Fabrice Peltier, INDP

Bruno Siri, General Manager

The CNE's Nine Colleges

Packaging material manufacturers, Packaging manufacturers,

Companies in the consumer goods sector and their suppliers, Retail companies,

Companies authorised by the public authorities to organise the collection and recovery of packaging waste on the national level and operators in the sector,

Consumer associations, Environmental protection organisations,

Local authorities, Other federations and companies.

THE FRENCH PACKAGING COUNCIL

71 Avenue Victor Hugo – 75116 PARIS

Telephone: +33(0)153648030 – Fax: +33(0)145017516

E-mail: [email protected] – Website: http://www.conseil-emballage.org

SIRET no. 41513678700025 APE: 9499Z