12 December 2022

Regulatory constraints: a complex aspect no to take lightly when choosing appropriate packaging for your sensitive products

Technical and economic requirements are often put at the forefront when looking at difficulties penetrating international markets. Regulatory requirements and the various rules that all add up from one state to another, one administration to another, and one industrial sector to another are sometimes underestimated. You may think that industrial packaging for sensitive products is not affected by this as much: this is far from the case, especially for the pharmaceutical and chemical sectors and the food industry. Overlooking these constraints can have serious consequences.

 I/ What types of constraints are there for industrial containers?

Tests to ensure the product’s compatibility and stability with its packaging are often standardised, especially for active ingredients in medicines: the various pharmacopoeia require standardised test procedures (for example, in terms of duration, temperature, humidity, etc.) with precise objectives for non-interaction between the contents and its packaging.

To guarantee its safety, packaging in contact with food must meet increasingly strict requirements that vary according to the region. So, some components cannot be used during manufacturing.

For the pharmaceutical markets, the authorities in some countries require a registration document (DMF or Drug Master File) for primary packaging in direct contact with APIs (Active Pharmaceutical Ingredients). This very substantial and detailed file is registered by the packaging manufacturer with the appropriate administration (FDA in the USA[1]).

Most industries now require thorough traceability of packaging and its components, as well as its manufacturing cycle.

Sealing and physical integrity tests must guarantee that no packaging logistics or use constraints will alter the product’s properties when it is used.

Hazardous products and their transportation are subject to strict regulations requiring suitable labelling and UN approved This guarantees that the packaging has gone through a series of stacking, drop, and pressure tests approved by an official laboratory – see the article “Choosing the right packaging to transport your dangerous materials”.[2]

Environmental constraints vary from one region to another and for one packaging material to another. Europe has enacted several decrees to encourage and make it easier to reuse and recycle packaging. This starts with identifying the packaging materials, forbidding or limiting certain components, as well as requiring a certain recycling rate or even forbidding single-use plastic packaging by 2040 as stipulated in the AGEC law.

Customs, health or logistical constraints top off the list of obligations, often requiring additional documentation or the processing of pallets.

 

II/ How to meet all these regulatory requirements?

At multinational corporations experienced in exporting sensitive products, a multidisciplinary team is often set up to address these constraints. These teams also rely on their packaging suppliers and their in-house services to anticipate all national requirements or those specific to their sector.

Average-sized companies can call on independent consultants, administrations, or their local correspondents to handle some demands. A good partnership with a reliable packaging supplier well used to international requirements will however help avoid discrepancies and the use of external service providers.

The reliability of your packaging manufacturer is key to ensuring compliance with all regulations throughout a product’s use: packaging material compatibility, reliable and certified manufacturing process, trusted organisation and effective support for packaging and regulatory issues.

 

III/ Tournaire helps you comply with regulatory requirements 

With over 180 years of experience in industrial packaging, Tournaire helps you to choose and design your packaging right up to its qualification and, of course, throughout the sale of your sensitive products.

With Tournaire, you can rely on:

– A multidisciplinary team to help you choose or develop your packaging, from the development of your product: choice of materials, finishes, types of closures, types of outer packaging, etc.

– A laboratory that can conduct content-container compatibility tests and various stacking, drop, and leak tests among others.

– Direct access to our files (DMF), UN certification and approval to help you approach regulated markets more easily.

– Complete documentary support: detailed information about the packaging materials, seals, varnishes, procedures, etc.

– Recommendations for outer packaging suited to your logistics requirements: pallets, boxes, various protections – see the article “Protecting your sales packaging to provide maximum satisfaction for your clients”.[3]

– A Quality Hygiene Security Environment organisation certified ISO 9001, 14001 and 45001 with a high level of social commitment confirmed by a gold Ecovadis medal in 2022.

Tournaire can assist you during your regulatory proceedings and help you to access all your markets faster and with greater peace of mind.

Feel free to contact our teams via this contact form.[4]

 

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[1] https://www.fda.gov/

[2] https://www.tournaire.fr/choisir-lemballage-le-plus-adapte-au-transport-de-vos-matieres-dangereuses/

[3] https://www.tournaire.fr/bien-proteger-vos-emballages-de-vente-pour-la-plus-grande-satisfaction-de-vos-clients/

[4] https://www.tournaire.fr/produits-services/emballage/contact/