Regulatory Compliance for Flavors & Fragrances Industry

The complex regulatory environment surrounding the Flavors and Fragrances industry results in costly management and maintenance of compliance systems. The threat of fines and missed shipments are a concern but the financial effects of one major recall can hold the brand at ransom and destroy a company's image, resulting in lost market share and potentially even bankruptcy.

Atrion International enables its customers in the Flavors and Fragrances industry to leverage regulatory product compliance as a sustainable competitive advantage. Combining sophisticated software tools, and value-added, highly dynamic Managed Regulatory Content, Atrion’s solution ensures that compliance assessments as well as regulatory documents are in keeping with the regulations of over thirty countries, in over 40 languages.

Specific Flavor & Fragrances Content

Atrion International’s product compliance solutions and Managed Regulatory Content are developed with industry distinctiveness in mind. Here’s a glimpse of our offerings, which aptly address regulator roadblocks for the flavors and fragrances industry.

IFRA Certificates Implementation

The International Fragrance Association (IFRA) Code of Practice (CoP) prescribes standards for the safe use of certain fragrance ingredients in consumer products. Traditionally, different limits were set for targeted ingredients, based on two simple categories of products (leave-on skin, rinse-off). In the 40th amendment of it's CoP, the IFRA introduced 11 end-product categories (shampoo, toothpaste, lipstick...) against which different limitations are set for each concerned substance.

The introduction of these additional categories makes it more difficult than ever to determine the Maximum Allowed Concentration (MACs) of a given fragrance substance or mixture.

Atrion streamlines the production of an IFRA certificate by implementing the concentration limits for all restricted and prohibited substances by IFRA, and this for every category. Rules are also included in our software, enabling the determination of the MAC for any substance or mixture of fragrance material by taking in account all the limitations set by IFRA. Furthermore, the changes to the IFRA CoP are monitored and our data is kept up-to-date to ensure continuous compliance with the latest information available.

EFFA Code of Practice

The European Flavors and Fragrances Association (EFFA) publishes a list of substances commonly used by the industry. For each substance, EFFA proposes compliant classifications based on the current classification scheme enforced in Europe.

Atrion implements the published Risk and Safety phrases in its DataLink products, so it can be leveraged readily by standard rules calculating the classification for simple substances or complex mixtures (calculation compliant with the EU CLP). The changes to the EFFA Code of Practice are monitored to ensure Atrion has the most complete and up-to-date set of data to create safety data sheets and labels compliant with the European classification scheme.

Allergen Certificate

It is a common request to prove that your product does not contain any of the 26 allergens identified by the European cosmetics directive.

Atrion supplies the list of 26 allergens with DataLink, and offers a customizable template that calculates the net content of each of the 26 allergens in finished products. The calculation also allows you to distinguish between direct and indirect (from raw materials) contributions.

Colipa’s Fragrance Safety Evaluation

This important ‘Business-to-Business’ standard template is an integral part of Atrion’s offerings. This document is an aggregate of many pieces of information (application of cosmetics directives, IFRA information and substance classification). Because all these pieces are part of our Managed Regulatory Content, this document can be produced in an integrated and automated way, ensuring productivity and consistency with other related documents such as the safety data sheets (MSDS / SDS), labels, IFRA certificates.

FEMA and FDA Lists

These lists, incorporated into our Managed Regulatory Content, allow a company to conduct screening in order to assess regulatory constraints applicable to its raw materials or finished products.

Learn more about Atrion's solutions for REACH & GHS.