We at JIOrings, as distributors, comply with both REACH and RoHS.
The design, which includes the formulation of rubber compounds (mixtures), is becoming increasingly complex due to the increase in regulatory requirements in Europe and the world in general. Here are some examples of regulations:
- The REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation.
- The Food Contact Materials Regulation.
- The Drinking Water Directive.
- The RoHS Directive on the Restriction of Substances in Electrical and Electronic Equipment.
- The SEVESO Directive.
- The CLP (Classification, Labeling and Packaging) Regulation regarding the classification, labeling and packaging of substances and mixtures.
These standards result in materials becoming obsolete and require the implementation of constant vigilance.
In was in June 1999 that the World Health Organization (WHO) made the following declaration at the Health and Environment Conference: “The environment is the key to improving health”: REACH is a European regulation launched in 2007 (REACH is has since been copied in numerous countries) in order to fully protect human health and the environment against the risks of exposure, assimilation and spillage in the usage of chemical products. A complete overthrow of the need for testing has occurred and industrialists are now required to manage the risks posed by chemicals. In addition, 8 years after the introduction of REACH:
Candidate List of Very High Concern (SVHC)
According to the EU ECHA regulation (Reg. 1907/2006), as well as Directive 2008/98/CE on waste to the (EU) 2018/851, manufacturers must provide information on SVHCs (Substances of Very High Concern) in their products along with other information to ECHA via the central SCIP database (Substances of Concern In articles as such or in complex objects (Products)). This requirement applies to all manufacturers and sales organizations that supply products to the EU, so it also applies to JIOrings, S.L. The regulation requires a declaration in the SCIP-ECHA database, if the articles and/or compounds manufactured or marketed contain any SVHC (Substances of Extreme Concern) that are listed in the following updated database.
In accordance with the foregoing, JIOrings, S.L. certifies that according to the information provided to us by our manufacturers and to our knowledge, all the compounds of the products we sell do not contain any of the substances classified as SVHC in a concentration greater than 0.1% w/w. Therefore, the compounds of the O-rings distributed by JIOrings do not require a declaration in the SCIP-ECHA database.
In accordance with these constant regulatory changes (updating of the lists at least every 6 months), formulations need to be reviewed and foreseen in a sustainable manner). As of today, the rubber industry has had to implement a surveillance system adapted to products/materials. More than a hundred substances are under surveillance while others have already been replaced.
However, REACH is not the only regulation industrialists have to deal with. Rubber materials in contact with food must comply with Regulation 1935/2004 and Regulation 2023/2006, in addition to different laws imposed in each of the countries of the Union. Being familiar with all these lists of substances is an essential requirement for anyone wishing to market materials that are likely to come into contact with food in order to guarantee the health of consumers and users.
Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals
As downstream users, we make a vital contribution to the goal of ensuring chemicals are safe, in addition to promoting the safe use of our materials in their respective workplaces and providing both our suppliers and customers with relevant information.
RoHS – Restriction of Hazardous Substances
RoHS is a directive adopted by the European Community in February 2003 (2002/95/EC) and is aimed at reducing the use of a number of hazardous substances in electrical and electronic equipment. It has recently been replaced by Directive 2011/65/EU, which covers the previous regulation, but extends to other products besides electrical and electronic equipment.
MSDS – Material Safety Data Sheet
A material safety data sheet (MSDS) is a document specifying the specific characteristics and properties of a certain substance for the most appropriate use thereof. The main objective of this sheet is to provide information on the properties of the substances or mixtures, the hazards involved and instructions on handling, disposing and transporting them. Although it is only mandatory to provide an MSDS to downstream users for:
- Substances and mixtures classified as hazardous in accordance with the CLP Regulation.
- Persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances.
- Substances included in the Candidate List of Substances of Very High Concern (SVHC).
And although this is not the case of the substances used in JIOrings products, all information to prevent risks is important.
Certificate of Conformity
We certify that the materials used to manufacture these seals comply with the FDA standard (CFR21 177-1550/CFR21 177-2600) and can be used safely in articles intended to come into contact with food. We also certify that the materials used to manufacture this seal also comply with the USP standard (Class VI-121C). The components used in the manufacture of our encapsulated seals are free of animal products (TSE / BSE / AFO), mercury and pthalates.
JIOrings delivery note
In addition, every time we make a sale, our system automatically generates the corresponding delivery note, a document containing a series of traceability data: batch, approvals, the name of the mixture, the statistical customs code, origin…
Moreover, we have all the certifications of our main suppliers. If you should need a specific mix, contact the Sales Department.
JIOrings will not be held liable for the manner in which customers use or come to use the seals we have sold them in compliance with all the legal requirements.