Scope and Exemptions of REACH Regulations

Scope and Exemptions of REACH Regulations in Italy


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The Ital­ian cen­tral admin­is­tra­tion has been work­ing to enforce reg­u­la­tions on the trade and activ­i­ties con­cern­ing chem­i­cal sub­stances and mix­tures since the late 1970’s.

How­ev­er, with the intro­duc­tion of REACH by the Euro­pean Chem­i­cal Agency in 2007, a more com­plex approach to the enforce­ment and man­age­ment was put in place. In order to coor­di­nate and ensure the ful­fill­ment of REACH reg­u­la­tions in Italy, a new gov­ern­ing body was formed head­ed by the Min­istry of Health: the REACH tech­ni­cal com­mit­tee.

Present­ly, the Ital­ian importers are required to reg­is­ter for REACH in addi­tion to ful­fill­ing oth­er import doc­u­men­ta­tions. As such, the US chem­i­cal com­pa­nies trad­ing in Italy are expect­ed to appoint a REACH Only Rep­re­sen­ta­tive.

To release importers of the reg­is­tra­tion oblig­a­tion and con­duct busi­ness smooth­ly. In this post, we will dis­cuss the scope and exemp­tions of REACH reg­u­la­tions in Italy which sub­stances, mix­tures or prod­ucts come under the REACH reg­u­la­tions to ensure com­plete com­pli­ance.

Scope of REACH Regulations

Most of the chem­i­cals sub­stances that are man­u­fac­tured, placed on the mar­ket or sim­ply used with­in the EU fall into the scope of REACH. These may be ‘sub­stances on their own’, used in mix­tures or as part of oth­er arti­cles. The low­er thresh­old for reg­is­tra­tion require­ment is 1 ton per year per reg­is­trant.

How­ev­er, there are oth­er oblig­a­tions under REACH that apply to cer­tain sub­stance man­u­fac­tured in the EU or import­ed even if the vol­ume is less than 1 ton per year.

These oblig­a­tions are con­cerned with the use of the sub­stance, restric­tions, and autho­riza­tion, and hence reg­u­la­tion is applic­a­ble irre­spec­tive of their vol­ume.

REACH reg­u­la­tions also applies to sev­er­al sub­stances occur­ring in nature. How­ev­er, if those sub­stances are not chem­i­cal­ly mod­i­fied, they might be eli­gi­ble for exemp­tion under REACH.

Exemptions from REACH Regulations

The rules and reg­u­la­tions of REACH apply to all the chem­i­cal sub­stances with the few exemp­tions- sub­stances under the cus­tomized super­vi­sion, non-iso­lat­ed inter­me­di­ates, and the var­i­ous radioac­tive sub­stances.

Waste is also an exempt­ed prod­uct as it is not a prepa­ra­tion or an arti­cle with­in the mean­ing of REACH.

Sub­stances such as car­bon diox­ide, water, and oth­er organ­ic sub­stances like veg­etable oils, cel­lu­lose pulp, and fat­ty acids etc, need not be reg­is­tered under REACH.

Also, the sub­stances used for R&D, bio­cides and plant pro­tec­tion prod­ucts, food and food addi­tives and the sub­stances recov­ered in the EU do not to be reg­is­tered again.

CAPLINQ offers reli­able REACH Only Rep­re­sen­ta­tive ser­vices to US chem­i­cal com­pa­nies plan­ning to expand in Italy and oth­er Euro­pean Union coun­tries. To learn more about our REACH Ser­vices you can vis­it www.caplinq.com or con­tact us direct­ly to learn all about REACH Reg­u­la­tions.

About Chris Perabo

Chris is an energetic and enthusiastic engineer and entrepreneur. He is always interested in taking highly technical subjects and distilling these to their essence so that even the layman can understand. He loves to get into the technical details of an issue and then understand how it can be useful for specific customers and applications. Chris is currently the Director of Business Development at CAPLINQ.

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