Cross Border Compliance: Navigating Regulatory Requirements

Have a new product idea that needs regulatory review? Thinking about expanding a product to other geographies and not sure of the regulations? Concerned about how an ingredient change might affect product registration?

Regulations for personal care and household products are continually changing and can be even more complex with differing global, state, local, and country laws and registration requirements. The regulations are meant to ensure product safety, labeling accuracy, and consumer protection but can add substantial lead time to the product development process if not managed proactively.

An outside expert can help with faster market entry and reduce compliance issues and legal risk. Some typical areas our consultants work in include:

Product Safety Assessments:

Determine what product testing is needed to establish safety, propose or conduct the testing, analyze testing results, and prepare documentation to remain in compliance with regional and national safety requirements.

Ingredient Restrictions:

Review formulation ingredients for any substances which may be banned or restricted by area. Additionally, if any included ingredients need to be replaced, they can propose alternative ingredients by jurisdiction or propose a reduced content to meet the regulations.

Labeling Requirements:

Assist in developing proper labeling which meets local and regional requirements. These requirements vary by product type and region, but typically include content labeling, weighted ingredient listing (INCI), manufacturer information including batch and lot codes, expiration dating, and any precautions for use.

Product Claims:

Review and / or determine allowable claims based upon the supporting data available and ingredients. Additionally, a regulatory consultant can appropriately classify claims (drug, performance, marketing, etc.) to ensure compliance with regulations by jurisdiction.

Good Manufacturing Practices (GMP):

Identify any processes and gaps which could result in product inconsistencies or safety concerns.

Product Notification (Registration):

Develop plans around product notification, or product registration, with the appropriate governing bodies before market entry. Product notification is required before market entry in many regions including the EU.

Even companies with a Regulatory department often need a specialized expert or additional resources to help with new product launches or reviewing existing products as regulations change.

Our consultants are skilled at navigating all these regulatory requirements and leveraging their broad experience, insights, and networks to develop solutions. They have deep industry knowledge and know international regulations, how to optimize ingredient selection, and can advise on ingredient sourcing, packaging materials, and manufacturing partners.

On Line Design, Inc. has experts across a variety of regulatory divisions including cosmetics, personal care products, home care, and more. Contact us for more information to help with your specific needs.