Product Safety
Commitment to quality and sustainability
As a manufacturer of hygiene products, quality and product safety are our key priorities. Safety is controlled along the whole value chain from component validation, through finished product testing and manufacturing, but also when the product is on the market. This strategy allows us to cover the entire product life cycle.
Ensure safety at the source
All raw materials are selected carefully in accordance with all applicable regulations on product safety. Furthermore, we want our products to be compliant with various other legal obligations, official recommendations, code of practices, and voluntary commitments.
We ask our suppliers to state their compliance with all those regulations and standards.
We require complete transparency on material composition from our suppliers.
All intentionally added substances need to be communicated to Ontex and a trace chemical report must be shared.
This allows us to perform a toxicological exposure-based risk assessment and ensure the level of chemicals present is safe.
Our suppliers also need to prove the excellent biocompatibility of their materials with direct skin contact. Biocompatibility is the ability of a material to perform its desired function while being in contact with a living system without causing any local or systemic (distinct to contact point) adverse effect.
Testing
Testing our components and finished goods is part of our safety evaluation strategy which goes beyond any regulatory requirements.
Monitoring traces of unwanted substances down to parts per million, even per billion, is done on representative finished goods under the EDANA Stewardship Program.
The EDANA Stewardship Program is an industry voluntary initiative that defined a list of substances of concern, their level of acceptance, and a realistic methodology to quantify them.
Moreover, we have certified an exponential number of product compositions over the years under OEKOTEX STANDARD 100 class 1 certification.
OEKO-TEX® is one of the world’s best-known labels for textiles tested for harmful substances.
It stands for customer confidence and high product safety.
This certification is fully integrated into our strategy to keep safe control of product composition.
Microbiological evaluation is also performed during production, following strict standards such as the European Pharmacopoeia.
And finally, after ensuring perfect biocompatibility of components, dermatological/gynecological tests are performed on representative finished goods to ensure perfect compatibility between the product and its user.
Quality control and safety
We maintain a quality culture supported by appropriate processes as part of the Quality Management System aiming to drive compliance, end to end focus and ensure decision making by putting product quality, patient, consumer, customer requirements and safety first. Certification with ISO 9001:2015 and ISO13485:2016 is a statement of compliance to Quality and a performant Management System. Some of our sites are additionally certified to the BRC and IFS HPC standards.
Advocacy & market surveillance
Each complaint is treated carefully and immediately by our teams.
When a complaint is related to safety topics, our experts analyze it and perform a counter analysis and safety assessment.
Post-marketing surveillance and vigilance activities such as complaint investigations, test results, published articles, scientific studies, new regulations, and voluntary standards allow us to continuously adapt our requirements for the whole value chain.
Ontex has been an active member of EDANA* for over 25 years.
We actively participate in building industry safety standards within different Steering Committees and Working Groups.
We are also members of other local industry associations such as BAHP** in North America or Group’hygiène*** in France.
Actively participating in those advocacy initiatives allows us to properly define with our partners the standards to meet the expectations of regulatory bodies and consumers.
* EDANA is a leading global non-woven association focusing on Europe, Middle East and Africa.
https://www.edana.org/about-us/who-we-are
** BAHP is a trade association which serves the absorbent hygiene products value chain in North America.
https://www.bahp.com/
*** Group’hygiène is a French association representing single use hygienic products.
https://www.grouphygiene.org/fr/