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REACH SVHC Free Certification

Non-testing approach to compliance with the SVHC free certification demanded by European buyers of “articles”

INTRODUCTION

Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) is a European Union Regulation and addresses the production and use of chemical substances and their potential impacts on both human health and the environment.

The impact of REACH is not only on the chemical industry but also on the article producers/importers.Articles such as electrical equipments, electronics, toys, garments, tiers, tools, plastic products, auto components etc, are all affected by REACH. For example, chemical companies need to do REACH registration and prepare SDS. Following are the various industry sectors impacted by REACH:

REACH also addresses the continued use of chemical 'substances of very high concern' (SVHC) because of their potential to have negative impacts on human health or the environment. The SVHC include substances which are carcinogenic, mutagenic or toxic according to the criteria in Annex XIII of the REACH regulation. The list of SVHC substance is published by the agency under the name of ‘Candidate List’ and presently the list has 53 SVHC substances. From 1 June 2011, the European Chemicals Agency must be notified of the presence of SVHCs in articles if the total quantity used is more than one tonne per year and the SVHC is present at more than 0.1% of the weight of the object.

Within REACH, an article is defined as an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition. It may be produced from natural materials, such as wood or wool, or from synthetic ones, such as polyvinyl chloride (PVC). Most of the commonly used objects in private households and industries are articles, e.g. furniture, clothes, vehicles, books, toys, kitchen equipment and electronic equipment.

Substances, mixtures and articles can be contained inside of packaging, such as a carton, a plastic wrapping or a tin can. The packaging does not belong to the substance, mixture or article being packaged and is therefore to be considered as a separate article within REACH.

The articles which are being exported to the 27 EU have the obligations of REACH compliance for all the substances which are present in the article. When determining if and which requirements apply, the first step is to check whether the objects produced and exported to the EU market are considered to be articles within REACH or not.

The various obligations for the successful compliance at various levels have been bulleted below.

  1. Comply with existing restrictions (Annex XVII of the REACH Regulation)
  2. The content of substances in articles can be restricted or banned under the restrictions procedure as per the conditions outlined in Annex XVII of the REACH Regulation.

  3. Register with ECHA substances in articles intended to be released (Article 7(1))
  4. Pre-Registration and Registration are required for the substances which have the property of intentional released from articles under normal and reasonable foreseeable conditions of use. The registration would be required if the total amount of the substance present in the articles with intended release exceeds 1 tonne per year per exporter. The complete process of registration would be similar to the registration process of a general substance under the REACH regulation.

  5. Notify ECHA of SVHC in articles under certain conditions (Article 7(2))
  6. Notification would be required if:

    • The substance is included in the candidate list of SVHC
    • The substance is present in the article above a concentration of 0.1% (w/w)
    • The substance is present in all articles produced or imported in an amount totalling over 1 tonne per year (per producer or importer) andThe substance is present in all articles produced or imported in an amount totalling over 1 tonne per year (per producer or importer) and
    • The substance has not yet been registered for that specific use
  7. Communicate in the supply chain (Article 33)
  8. The exporters to the EU market have the obligation to communicate the presence or absence of the substances published in the candidate list to the users down the supply chain. The format of the communication would be through Safety Data Sheet (SDS) where ever applicable. In case SDS is not required then the details have to be communicated as per the Article 32 of the regulation.

RELEVANT ARTICLES OF THE REACH REGULATION

Article 7

Registration and notification of substances in articles

  1. Any producer or exporter of articles shall submit a registration to the Agency for any substance contained in those articles, if both the following conditions are met:

Duty to communicate information on substances in articles

  1. Any supplier of an article containing a SVHC in a concentration above 0,1 % weight by weight (w/w) shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum……...

The relevant information shall be provided within …….

WHY TESTING CANNOT BE THE FIRST OPTION FOR CHECKING FOR THE SVHC (As mentioned in the guidance document published by ECHA)

“Although chemical analyses may be helpful in certain situations, it is to be noted that they may yield ambiguous results and/or be very costly and are thus not recommended as the preferred instrument for obtaining information”.

Other difficulties associated with chemical analysis include the following:

  1. Articles may be very complex and composed of different parts and materials. It is therefore difficult to create a sample for the analysis that represents the whole article.
  2. Substances that are included in the article matrix may have to be extracted from it.
    • This may result in chemical reactions that could “create” substances which do not exist in the article.
    • The extraction may not be exhaustive, thus the full content of substances in the matrix may not be obtainable.
  3. Some methods may show the existence of certain elements (e.g. halogens) rather than the existence of substances.
  4. If a high number of different substances are contained, several analyses may be needed to identify all substances, and it is particularly difficult to assign an appropriate method if it is not clear what is being searched.
  5. The quantification of substances requires additional measurements
Thus, chemical analysis is not required as the first step to demonstrate the presence or absence of SVHC in the articles; it may be an option when other methods for information gathering fail.

In the absence of test information, suitable non- testing methods may be sufficient to arrive at a conclusion if SVHC is present or not.

  • The first step of assessment is to find all the components present in the Article.
  • The second step is to note the raw materials which have been used in the process of preparing the components of the article.
  • Once all these raw material information has been collected then the same is checked through various databases available, the restriction list, etc, to assess the absence or presence of SVHC
  • Where there is a probability of the presence of SVHC, it will need to be quantified by testing
  • This reduces the cost of testing to the bare essential

CONCLUSION

At the end of this assessment procedure, a certificate is provided for the probability of the presence of SVHC or absence of SVHC; as the results of the assessment suggest. If the company has been suggested to quantify the SVHC, the analytical results of testing are evaluated. Upon evaluation, if the need for Notification to the ECHA arises, our company in Europe (Sweden) can provide the Notification service. If there is no need of Notification, a REACH compliant certificate is provided to the client. At the end of this assessment procedure, a certificate is provided for the probability of the presence of SVHC or absence of SVHC; as the results of the assessment suggest. If the company has been suggested to quantify the SVHC, the analytical results of testing are evaluated. Upon evaluation, if the need for Notification to the ECHA arises, our company in Europe (Sweden) can provide the Notification service. If there is no need of Notification, a REACH compliant certificate is provided to the client. At the end of this assessment procedure, a certificate is provided for the probability of the presence of SVHC or absence of SVHC; as the results of the assessment suggest. If the company has been suggested to quantify the SVHC, the analytical results of testing are evaluated. Upon evaluation, if the need for Notification to the ECHA arises, our company in Europe (Sweden) can provide the Notification service. If there is no need of Notification, a REACH compliant certificate is provided to the client.

Co-ordinator,

REACH Support, Nagpur, INDIA(http://www.reach-support.com) (www.reach-or.com)

For Sustainability Support Services (Europe) AB, SWEDEN (www.sustainability-support.com)

Quotes from Companies

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