SYBILLE MILLET
Regulatory affairs manager, COSMED

Abstract

The sale of bulk cosmetics is booming, due to growing consumer expectations, and to a strongly encouraging legislative framework, like that in France. COSMED takes stock of this new format, reminding us of the vigilance points to be taken into account in order to remain in compliance with the European cosmetic regulation, and the Good Manufacturing practice. This implies adapting product development, creating new procedures, and training shop and consumers in this new distribution method.

INTRODUCTION
It is a fact, the sale of product without primary packaging, commonly known as “bulk sales” is growing. Not only in food but also in cosmetic. This format is more and more appreciated by consumers because of its “environmentally friendly” side. A regulatory framework is being defined, particularly in France, in order to develop this distribution method.

EXAMPLE WITH THE REGULATORY FRAMEWORK IN FRANCE
In February 2020, the law n°2020-1051 on the circular economy and the fight against waste was published in France. This law strongly impacts cosmetic products in many aspects. However, bulk sales are mentioned (article 41), and are strongly encouraged. They are defined as: “the sale to the consumer of products presented without packaging, in quantities chosen by the consumer, in refillable or reusable container. Bulk sales are offered on a self-service”.

With this law, all everyday consumer products can be sold in bulk, except for a specific list defined by decree (for public health reasons).

It is now written in the French Consumer Code2 that:
“In retail outlets, the refillable container may be provided by the retailer at the point of sale or brought by the consumer.”

Any final consumer may ask to be served in a container brought by him, provided that the container is visibly clean and suitable for the nature of the product purchased.

A display in the shop informs the final consumer about the rules for cleaning and suitability of reusable containers.

In this case, the consumer is responsible for the hygiene and suitability of the container.

The trader may refuse the service if the container offered is obviously dirty or unsuitable. »

“Retail businesses with a sales area of more than 400m2 shall ensure that clean refillable or reusable container, replacing single-use packaging, are made available to the final consumer, free of charge or for a fee, in connection with the sale of products presented without packaging. »

The regulatory framework is further strenghtenen with the Bill to combat climate change and strengthen resilience to its effects (3), more commonly known as the ‘Climate and Resilience Bill’ which has been published on the 24 August 2021.

This new law requires that by 1st January 2030, retails shops with a surface area of more than 400m2 to devote for bulk sales and sales of products without primary packaging 20% of the sales area, or an equivalent expressed as a number of references or as a proportion of turnover. Further details on the objective per product category and on implementation should also be defined., but bulk sales are thus strongly encouraged in a legal manner.

The sale of cosmetics in bulk will thus necessarily develop to reach the objective, but this must be done while respecting the regulatory requirements for cosmetics.

Cosmetic products, in France and in the European Union, are governed by the Cosmetic Regulation (EC) n°1223/2009. Manufacturing and packaging must be done according to Good Manufacturing Practices (GMP), defined by the ISO 22716 standard. This standard sets out the objectives to be achieved, but not the way. The bulk sales format introduces new challenges with regard to GMP and the requirements of the cosmetics regulation, but these are not insurmountable, provided that certain points of vigilance are taken into account.

WHAT ARE THE OBLIGATIONS TO BE COMPLIANT WITH THE COSMETIC REGULATION?

French specificity
In France, any manufacturing site of cosmetic products have to be declared to the National Agency for the Safety of medicines and Health Products (ANSM). On the same scheme, establishments that carry out packaging of cosmetic products at the point of sale have to be declared, except if the step consists in packaging solid cosmetic products (soaps).

Clearly defining responsibilities in a contract
The manufacturer placing a bulk product on the market is the responsible person for the product within the meaning of the Cosmetic Regulation. He is thus responsible for the conformity and safety of his product and must comply with all the requirements of the Cosmetic Regulation. Thus, the packaging of cosmetic products at the point of sale can only be set up by a distributor in agreement with the responsible person. A contract must be established specifying the responsibilities and tasks of each party. In particular with regard to:

• batch traceability;
• staff and consumer training;
• hygiene of equipment and room;
• the packaging items to be used;
• the labelling to be provided

Take into account this mode of distribution from the development stage
This mode of distribution must be taken into account in the safety assessment, the responsible person has to fill in all relevant elements in the Product Information File (PIF).

This involves stability/compatibility studies on the container that will be provided by the distributor or that may be used by the consumer.

Because of the consumer’s choice of quantity served, the stability study should take into account this incomplete filling of the product, including prolonged contact with air. The expiry date should be assessed taking into account this filling method. To be noted, while cosmetic products may have a date of minimum durability or a Period After opening (PAO), the PAO is not suitable for bulk sales, as the product is open in store. The exact expiry date should be indicated to the consumer.

The extended life of the packaging due to its successive reuse must be taken into account in the compatibility study of the packaging.

The compatibility of the filling equipment with the product must also be assessed.

The cleaning protocol to be passed on to the consumer and the shop should be evaluated and indicated in the PIF.

If the shop or distributor has defined and implemented a standard and common cleaning protocol for the cleaning of bottles and equipment in the shop, the suitability of this protocol for the product must be confirmed by the responsible person.

Consumer information
The consumer is made responsible for the hygiene of the container, but only up to a certain limit. This implies clear and appropriate labelling and instructions.

Products sold in bulk are not exempted from the labelling requirement of Article 19 of the Cosmetic Regulation.

This information must be available for the consumer prior to his choice of product (not only the INCI list, the product identity, the precaution for use but all the information required in Article 19).

The manufacturer shall provide for the supply of labels or leaflets. The distributor shall ensure the consumer information at the time of sale.

If containers are considered unsuitable, as may be the case for the distribution of perfumes or oils, provision should be made to inform the consumer and the distributor.

The date of minimum durability must be mentioned.

In order to guarantee product traceability, batch tracking must be ensured. In the case of automated distribution, for example, information on the date and time of filling, transmitted back to the consumer, can be a means.

In-store signage should avoid any risk of confusion for the consumer. Equipment should be clearly identified.

In the case of formula changes, it is important to ensure that the information is clear to the consumer, particularly in the case of packages brought in by the consumer to be refilled, which would already carry an old label.

Product monitoring
The management of cosmetovigilance and any adverse effects will have to be adapted to this distribution method. Procedures must be put in place.

In the same way as for the distribution of finished cosmetic products, the control of products distributed in bulk must be adapted according to the risk analysis performed.

WHAT ARE THE POINTS OF VIGILANCE TO RESPECT THE GMP?

Notion of chosen or defined quantity
There are two possibilities: the consumer chooses the exact quantity he needs, or the bottle is refilled for a fixed and defined quantity.

In the first case, it is necessary to respect the requirements linked to metrology, in particular through the use of scales, calibrated and controlled. This option represents a real challenge for e-commerce sites.

In the second case, the use of a graduated container can be a way of ensuring the quantity refilled, in the absence of weighing.

Manual or automated filling
Solutions are being developed to facilitate the delivery of bulk, including automated filling. This can simplify compliance with metrology, hygiene and traceability requirements.
If the filling is done manually, the intervention of an operator is preferable to ensure the control of traceability and hygiene rules. Greater vigilance will be required if the consumer serves himself.

New protocol and operation at shop/boutique level:
The reception of bulk goods, the identification of products, the respect of the FEFO (First Expired First Out) and FIFO (First In First Out) principles in the stock management. All of this must be the subject of a protocol at shop level.

If the shop is to manufacture bulk, all GMPs must be followed, from weighing to sampling.

The shop undertakes to respect the cleaning and disinfection protocols. The RP remains responsible according to cosmetic regulation, and can organise control.

Staff/consumer training
It is essential that staff at the distribution point are trained in GMP, whether they are in charge of refilling the product directly, or supervising it if the consumer refills it himself.
This includes checking the bottles (cleanliness), cleaning the nozzles and equipment, monitoring traceability, compliance with metrology requirements, compliance with hygiene rules, FIFO, etc.

Staff should be trained in the procedures.
The consumer should also be made aware of the hygiene rules. The protocol for cleaning and filling the bottles must be displayed.
COSMED is currently discussing with the French authorities to define and frame this concept, and will also bring the subject to the European Commission level. To be continued.

REFERENCE AND NOTES

1. Loi No. 2020-105 du 10 Février 2020 sur la lutte contre le gaspillage et l’économie circulaire
2. Code de la consommation français – Article L120-2 et Article L. 112-9
3. Loi française No. 2021-1104 du 22 août 2021 portant lutte contre le dérèglement climatique et renforcement de la résilience face à ses effets.

ABOUT THE AUTHOR

Sybille MILLET is regulatory affairs manager at COSMED, specialized in EU cosmetic regulations and in charge of the representation. COSMED, the French Professional Association for SME in the cosmetic field, counts 920 members. COSMED participates in the European Commission’s working groups on the Cosmetics Regulation and contributes to the development of a regulatory framework for the marketing of safe and effective cosmetic products. Cosmed regulatory monitoring is a tool that helps companies to be informed of cosmetic regulation in Europe and abroad, thanks to an extensive database on 120 countries, real time alert and assistance. (www.cosmed.fr)