The Reach Regulation in the sector of packaging and packaging

Regulation (EC) No. 1907 / 2006 of the European Parliament and of the Council, concerning the registration, evaluation, authorisation and restriction of chemicals (Reach) and the substances, has been the implementation of an ambitious piece of legislation, whose main objective is to ensure a level of protection of human health and the environment, through the improvement of the knowledge of chemical substances, as such, in preparations or in articles.

Since its entry into force last June 1, 2007, the Reach regulation represents an essential milestone in the regulatory control over existing chemical substances, raised many questions about its impact on different industrial sectors. In general, the provisions set by the Reach Regulation apply to the manufacture, marketing or use of substances, as such, in preparations or in articles. There are some exceptions, such as radioactive substances, substances under customs supervision or waste, however individual cases should be explored to check the level of requirement of the regulations for each type of substances.

For those substances under the scope of Reach, the manufacturers and importers of the European Community have an obligation to submit an application for registration for each substance manufactured or imported in amounts greater or equal to the annual ton per company (legal entity). The deadline for submitting the registration ended on June 1, 2008, however the Reach Regulation provides also the process of pre-registration, which allows you to benefit from wider limits, depending on the toxicity of the substance and the tonnage stated. As aspect key in the implementation of Reach, there is no marketing without registration and as a result, only registered substances may be used as raw materials in companies located in territory of the Union.

The packaging sector is characterized by the wide range of activities included in the generic denomination of 'packaging and packaging', as well as a considerable diversity of production processes and raw materials used. In general, we can find those companies linked to the manufacture and/or distribution of machinery, as well as those engaged in the packaging, almost exclusively, encompassing both manufacturers such as importers and distributors.

In relation to the impact of Reach on the sector, the companies related to the packaging are affected most directly, both considering the materials used (wood, metal, paper, paperboard, complex cardboard, corrugated cardboard, plastic and glass), as well as to the sectors to which it is addressedmainly food, chemical, cosmetics and perfumes, beverages and pharmaceutical. In this sense, the sector of the packaging, any manufactured product and regardless of the raw material used, it will be affected by the regulation. Each company must comply in a manner specified by the requirements established by the regulation, depending on the agent type to represent the nature of substances that you use and/or imported and its application in the production process.

As an initial step in the analysis of the impact of Reach, the company must know what type of agent is part of the chain of uses of a chemical substance. So obviously, the account in the first instance as 'intermediate users', to the extent in which the development of the activity as such substances are used and more commonly as substances contained in preparations.

As intermediate users, the impact of Reach can be critical for the continuity of production processes, to the extent that only raw materials whose substances are recorded in the European Chemicals Agency may be used.

The application for registration includes the assessment of the chemical safety of the substance, where the manufacturer must incorporate the authorized uses of the substance, as well as the possible scenarios of exposure of the substance in its life cycle. Both aspects, applications and scenarios, will be communicated to the user of the product through safety data sheets extended, being an essential condition its compliance.

On the other hand, special impact to the sector, is the figure of 'producer of articles'. Consideration by producers of articles involved, as for intermediate users, the need to meet certain obligations and responsibilities, depending on whether the substances incorporated in the article during the production process are intended to rid, such as aromatics, or on the contrary case will form part of the material in its array or surface, as it is the case of inks or adhesives. In this regard, and save in exceptional cases, substances in the packaging will not are to released in normal use.

In such a case, and according to the rules of procedure, the producer of the article would have to identify if any of the substances incorporated into the container and packaging is considered as a substance of very high concern.

In relation to the principal obligations, producer and/or provider of the packaging or packaging that contains substances of very high concern in a concentration above 0.1% by weight/weight (w/w), it must communicate to your customer or at the request of a consumer the name of the substance and sufficient information to enable safe use of the article. The corresponding information will be provided, free of charge, within a period of 15 days from the receipt of the request. In addition, must be notified to the European Chemicals Agency if a substance meets the criteria of the article 57 of Reach (substances of very high concern).

In addition to the previous actors, there is a large number of companies that matter so much as preparations substances and articles, becoming importers of substances, assuming the same obligations as the manufacturers themselves. In the case of the importer of substances and/or preparations, prior to the import, you must check if substances have been prerregistradas or registered in the European Agency, and if not, you can no longer use the substance or preparation containing such a substance. As importer of articles, will have the same obligations as a producer of articles, and quantify the presence of substances of very high concern in the containers and packaging imported.