Category: Compliance

You can use Product Manager to manage your safety data which can be exported as the basis for the safety assessment – also known in the EU as the Cosmetic Product Safety Report (CPSR). Safety calculations such as Max. Daily Exposure, SED and MoS are performed and all safety data can be exported to Excel. In 2021 a new template-based CPSR module will be released for generation of the safety assessment. Please note, that in countries where the safety assessment is a requirement (such as in the EU), the CPSR must be physically signed by a person qualified to serve in the role as a safety assessor.

See the Product Manager User Guide for further support.

Product Manager’s ingredients database includes over 31,000 single ingredients for possible use in cosmetics and personal care products. Over 99% of required ingredients can be found in this list. If you search for an ingredient in any of the following pages/tabs of Product Manager and cannot find the ingredient, a ‘Submit Ingredient Request’ button will be displayed. Before contacting us, please do the following:

  1. Contact your supplier wherever possible, if the ‘missing’ ingredient is not clearly stated in any raw material SDS in terms of its INCI and CAS no. (see section 3 of the SDS).
  2. Use Google to verify that any INCI and/or CAS you have is correct. Check for example, if you are confusing the common or chemical name with the INCI.
  3. Check on the CosIng website that the ingredient is available there and is not in Annex II (banned substances). Here is the link:

    http://ec.europa.eu/growth/tools-databases/cosing/index.cfm?fuseaction=search.simple

  4. In CosIng and Product Manager, try searching for a narrower match of the INCI string you have instead of the entire INCI. For example, instead of entering “1,4 CYCLOHEXANEDIOL BIS-ETHYLHEXANOATE”, try “CYCLOHEXANEDIOL” and look for matches in the search results.

If the above steps show that the ingredient is available in CosIng and permitted for use in cosmetics and personal care products but cannot be found in Product Manager, please then forward the details of the ingredient to us and we will investigate.

A central pillar of the cosmetic regulatory framework in most countries is compliance with Cosmetics Good Manufacturing Practices (GMP) ISO 22716. For example, in the EU compliance with Regulation (EC) No 1223/2009 requires adherence to GMP and stipulates i). maintenance of complete and accurate documentation (para. 17) and ii). change control (para. 15). Paragraphs 6.4.4 and 7.2.1.2 set out requirements for documenting all batches of raw materials used to manufacture your product, as well as information on each supplier. Complying with ISO 22716 therefore extends responsibility above and beyond the regulatory requirements for maintaining up-to-date product information files (PIFs), resulting in complex and time-consuming administration for companies that have no effective system for managing these tasks.

A substance classified as CMR1B (or CMR1A) is prohibited in many countries from use in cosmetic products. By way of exception, the authorities may adopt measures for the authorization of these categories of substances. For example, in the EU all of the following conditions listed in article 15, paragraph 2 must be fulfilled:

  • No suitable alternative substances are available,
  • The application is made for a particular use of the product category with a known exposure,

    and

  • Assessment by the Scientific Committee for Consumer Safety (SCCS) of the European Commission concluding to the safety for use in cosmetic products.

Since regulatory data tends to be periodically updated by the responsible authority, we do not recommend importing such ‘static’ data to your Product Manager account. If you require additional compliance data and can provide us with a link to the official source data, we’ll be happy to review this and assess the possibility for including this data in Product Manager. Please contact us.

Since the European Commission’s CPNP portal does not allow integration with any third-party services such as Product Manager, you must submit your products manually. Entering and managing your product in Product Manager is a useful preparation for submitting your new product to the CPNP.

Compliance data is updated on a quarterly basis. Please note that the regulatory authority may not publish updates as regularly as this. EU CosIng data is updated daily. When checking compliance for an ingredient in your formula, you’ll see the date the data was last updated in Product Manager and the date it was published by the authority.

For further details on the compliance features and regulatory data available in Product Manager click here.

By maintaining batch traceable, up-to-date dossiers/PIFs for each of your products, following Cosmetics Good Manufacturing Practices (GMP) and exercising due care by consulting with a qualified, competent safety assessor, you will be positioned well for gaining compliance in whichever country you sell your products.

In our experience, most businesses fall foul of the regulators due to simple mistakes, or by not understanding the requirements of GMP ISO 22716 Unfortunately, some smaller businesses are still ignoring the regulations altogether! By using Cosmetri software you mitigate your risk and reduce the amount of time working on admin and compliance tasks instead of creating and selling your products.

For the E.U., Cosmetics Regulation (EC) No 1223/2009 states:

“Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by 11 July 2013 and shall notify it without delay of any subsequent amendment affecting them.”

In the event of infringement of the regulation, the so-called Competent Authority will first contact the Responsible Person. Remedial action will be required, and in cases where a real threat to human health is determined, a penalty will be incurred ‘proportionate to the violation’. In other words – make sure your products are compliant and that they stay compliant.

A central pillar of the cosmetic regulatory framework in most countries is compliance with Cosmetics Good Manufacturing Practices (GMP) ISO 22716. For example, in the EU compliance with Regulation (EC) No 1223/2009 requires adherence to GMP and stipulates i). maintenance of complete and accurate documentation (para. 17) and ii). change control (para. 15). Paragraphs 6.4.4 and 7.2.1.2 set out requirements for documenting all batches of raw materials used to manufacture your product, as well as information on each supplier. Complying with ISO 22716 therefore extends responsibility above and beyond the regulatory requirements for maintaining up-to-date product information files (PIFs), resulting in complex and time-consuming administration for companies that have no effective system for managing these tasks.