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REGULATORY MANAGEMENT



Formpak is a powerful tool for regulatory management; it's tuned to your business sector yet remains extendable. With standard and customisable documents, forms and properties, it delivers a highly effective combination of client specific needs and general regulatory requirements, right down to the final product, as used by your customers. It also integrates with other systems so you can share regulatory data easily across your company and divisions.

 

Regulatory Management Ethos

We know that regulatory affairs management is an increasingly complex and critical part of your business. Our goal at Formpak is to make it easier to manage regulatory affairs through the lifecycle of your product so you and your customer are always up to date. Formpak includes powerful and customisable tools which help you to:

  • Determine ingredient and formulation safety and status for the regulations relevant to you and your supply chain, including compliance to complex restrictions from customers

  • Record, calculate and report both technical and commerical attributes such as hazards and safety, global inventory status, allergens, nutritional data, origin, botanical and INCI names

  • At the touch of a button, print labels for your products and author complex documents such as technical data sheets, compliance certificates and Safety Data Sheets for multiple regions and languages

  • Automate document revisions and resupply - so you can easily keep your customers up to date with the latest relevant information for products you supply

  • Easily manage and view changes to product information within your business over time, with visibility about past information and the impact on documents. When you have a query about a change to a regulatory document, you can easily access the reasons - peace of mind for you and your customers.

Formpak activities will continue to be focussed on:

  • Understanding the legislation in great detail, monitoring new guidance and determining how this impacts our clients

  • Implementing software solutions within the Formpak system to enable clients to manage the changing requirements seamlessly

  • Being a direct resource for customers on legislation matters

  • Supporting industries by participation in technical committees and informing the wider community by giving talks at seminars

Please explore below some of the different regulatory topics covered by Formpak


Formpak software can help you manage the requirements of the Globally Harmonized System. We include as many automatic calculations as possible so that from one set of ingredient data, you can produce different GHS results based on regional rules, such as CLP and OSHA.

In addition, you can author different formats of compliant Safety Data Sheets and hazard labels in multiple languages. Transport classifications are also automatically calculated. If you have products with exceptions, you can easily override the calculated values to show other information.

For more information please visit our Globally Harmonized System page

Formpak can help you manage many aspects of Cosmetic regulations. You can generate INCI lists, including fragrance allergens. You can ensure compliance to cosmetic ingredient limits, in relation to specific applications and different customer requirements.

Regional cosmetic limits can be added for ingredients and results calculated for cosmetic formulations. This can include contributions from fragrances and essential oils.

Limits and other restrictions for ingredients and formulations can easily be calculated, reported and kept up to date. During product development you can access rapid feedback to be confident you develop compliant cosmetic formulations.

For more information please visit our Cosmetics page

Formpak can help simplify management of transport rules by automatically calculating the most appropriate Proper Shipping Name (PSN), transport class and group based on the GHS hazards of your mixtures.

The allocation of Proper Shipping Names can also be directly added for ingredients when very specifc PSN's apply.

There are standard transport rules in Formpak which can be adjusted and added to, so the most specific PSN is automatically allocated to your products, wherever possible and in different circumstances.

For more information please visit our Transport Regulations page

Formpak can manage the data required for Poison Centre Notifications including UFIs. You can generate Poison Centre Notifications directly in Formpak. The dossier is produced in the required i6z file format making submission to the ECHA portal process quicker and simpler.

For more information please visit our Poison Centre Notifications page

IFRA Standards can be fully managed in Formpak. Our team members have worked directly on IFRA standards for decades and understand both how IFRA limits should be calculated and why.

In Formpak you can add IFRA limits for chemicals, natural complex substances (NCS) and their components. You can group related components together to properly take account of all sources relevant to a Standard such as Citral. Based on the limits of ingredients and components, the IFRA limits for formulations can easily be calculated and kept up to date.

You can author IFRA Certificates for IFRA 49th and 48th Amendment independently, and automate how they are updated when there are changes to information.

For more information please visit our International Fragrance Association page

Many aspects of Flavour regulations can be managed in Formpak. For example you can ensure compliance to flavour ingredient limits, in relation to specific applications, apply rules relating to specific diets and ensure compliance even during recipe development.

You can also generate specifications and Technical Data Sheets at the click of a button, including nutritional data, ingredient labelling lists by weight of flavouring ingredients and also labelling 'for foodstuffs'.

Limits and other restrictions for ingredients and recipes can easily be calculated, reported and kept up to date. During product development you can access rapid feedback to be confident you develop recipes which comply to regional and customer specific requirements.

For more information please visit our Flavour Regulations page

For further information or to arrange an online demonstration, please contact us.